Executive Summary

The Evidence Bar™: Evidence is somewhat favorable

 

Description: Endotracheal tubes (ETTs) with subglottic secretion drainage (SSD) ports are used to provide mechanical ventilation to patients in whom respiratory support is expected to be needed for more than 48 hours.

Intended benefit: ETTs with SSD ports are intended to lower ventilator-associated pneumonia (VAP) risk. The tube is designed with a small hole in its rear, a channel running through the tube and connected to a suction port. The design is intended to prevent subglottic secretion pooling, assist in secretion removal, and prevent leakage into the lungs to avoid the bacterial accumulation that can lead to VAP.

Focus: This report focuses on ETTs with SSD ports’ safety and effectiveness for preventing VAP.

Conclusions: ETTs with SSD ports work as intended to prevent VAP in patients requiring mechanical ventilation for more than 24 to 72 hours. Meta-analyses of randomized controlled trials (RCTs) in systematic reviews (SRs) consistently show ETTs with SSD ports reduce VAP incidence compared with use of conventional ETTs. An additional small RCT published after these meta-analyses compared ETTs with SSD ports with silver-coated ETTs and found no difference in VAP rate, but these data need confirmation in additional RCTs. An additional small RCT reported no difference in VAP rate between ETTs used with and without SSD ports, but these findings should be added to a meta-analysis of RCTs.

Rationale: The RCTs in the SRs had low to unclear risk of bias in each of six bias domains assessed; one of the SRs also analyzed nine other published SRs that performed meta-analyses and then performed an updated meta-analysis; all these meta-analyses showed ETTs with SSD ports reduce VAP. The included RCTs were performed in different countries and assessed patients with different etiologies, patients who underwent different procedures, and ETT use as part of bundled VAP preventive measures, which may limit generalization and interpretation of results.

Evidence gaps: Larger multicenter RCTs comparing ETTs with SSD ports and conventional ETTs, antimicrobial- agent-coated ETTs, and ETTs with SSD ports from different manufacturers that report VAP incidence in various patient populations with similar characteristics and etiologies would be useful to clarify findings.  

Guidelines: Two documents consider ETTs with SSD useful for reducing VAP incidence in adults who require mechanical ventilation for more than 48 to 72 hours.

Who Should Read This

Background

Ventilator-associated Pneumonia

VAP is a lung infection that develops 48 hours or more after initiating invasive mechanical ventilation. Mechanical ventilation assists breathing in patients who have weak respiration and cannot independently breathe sufficiently to remain alive. Examples of invasive mechanical ventilation techniques include endotracheal intubation and tracheostomy. In endotracheal intubation, a physician places a long ETT in the patient's trachea (windpipe) through the mouth. In tracheostomy, the trachea is accessed through a small incision on the patient's neck. Tracheal secretion accumulation during intubation is a high risk factor for VAP, which can be caused by lung and lower respiratory tract colonization with microorganisms. Patients who need mechanical ventilation after a diagnosis of underlying severe hospital-acquired pneumonia or those with preexisting pneumonia or an underlying condition that causes pneumonia do not meet the criteria for VAP. In critically ill patients, VAP risk factors include prolonged mechanical ventilation, patient characteristics and comorbidities, and prior use of antibiotics. (For more information, see the UpToDate article Clinical Presentation and Diagnostic Evaluation of Ventilator-associated Pneumonia and the article by Wu et al. 2019.)

VAP is common complication that occurs in intensive care unit patients and is a high-risk factor for patient mortality. Timely diagnosis is vital to prevent VAP incidence and antibiotic overuse. Physicians diagnose VAP using a combination of clinical and imaging findings. Gradual or sudden onset of pulmonary infiltrates may be observed during chest imaging. Clinical VAP symptoms include fever, increased respiratory rate, decreased oxygenation, and purulent sputum. Microbiological assessment of respiratory samples to identify associated pathogens is key in VAP diagnosis, treatment, and management. In patients who received endotracheal intubation, VAP preventive measures include daily monitoring of the ETT's cuff pressure, patient head alignment, maintaining oral hygiene, and SSD for secretion removal. (For more information, see the UpToDate articles Clinical Presentation and Diagnostic Evaluation of Ventilator-associated Pneumonia and Risk Factors and Prevention of Hospital-acquired and Ventilator-associated Pneumonia in Adults and the article by Papazian et al. 2020.)

Endotracheal Tubes with Subglottic Secretion Drainage Ports

SSD ports used with ETTs are designed to facilitate continuous or intermittent subglottic secretion removal to lower VAP risk. Newer-generation tubes are designed with a small hole in the rear, a channel running through the tube, and connection to a suction port. The design is intended to prevent subglottic secretion pooling, assist in secretion drainage, and prevent leakage into the lungs to avoid microbial growth that can lead to VAP. Unlike older ETT models, some of the newer devices with SSD ports also have a barrel shape and low-pressure and high-volume cuffs intended to help lower the risk of secretion pooling. Preventing VAP purportedly reduces antibiotic use, length of hospital stay, and overall morbidity and mortality, all of which also depend on surgery complexity, disease etiology, and underlying comorbidities. Manufacturers supply ETTs with SSD ports that are sterile, made of different materials (e.g., polyurethane, polyvinyl chloride), and in multiple cuff sizes and inner tube diameters. (For more information, see the U.S. Agency for Healthcare Research and Quality document Benefits of Subglottic Secretion Drainage Endotracheal Tubes: Facilitator Guide, the website for the Microcuff Adult Endotracheal Tube, the website for the Sacett Suction Above Cuff Endotracheal Tube, and the website for the Shiley Evac Endotracheal Tube with TaperGuard Cuff.)

Clinical Literature

Search dates: January 1, 2017, through July 18, 2022. We reviewed full text of two SRs with meta-analysis (one was reported in two publications [original and erratum]) and two RCTs. These publications reported on 3,907 unique patients.

We searched PubMed, EMBASE, and selected web-based resources for documents relevant to this topic. Our search strategies included the following keywords: subglottic secretion drainage, ventilator associated pneumonia. Please see the Selected Resources and References section for detailed search strategies.

Study selection criteria: We sought comparative clinical studies that reported on VAP incidence in patients who underwent mechanical ventilation using ETTs with and without SSD ports. We selected the best available evidence, which consisted of SRs that meta-analyzed RCTs. We also included RCTs published after the search dates specified in the included SRs. We excluded nonrandomized comparative studies because of the availability of higher-quality studies (i.e., RCTs). We also excluded less comprehensive SRs and studies described as comparisons that assessed different SSD port procedures, protocols, or ETTs made of different materials because they did not report on patient-oriented comparisons of interest.

To avoid double-counting patients, we reviewed the most comprehensive or recent of any two publications with patient overlap; however, we included SRs with overlapping RCTs if they reported on different outcomes of interest. We excluded studies with fewer than 10 patients per arm and conference abstracts.

We identified and reviewed full text of two SRs and two RCTs. The 2 SRs with meta-analyses had an overlap of 9 RCTs (i.e., 1,250 of 3,757 patients overlapped).

Included SRs:

  • 1 SR (Pozuelo-Carrascosa et al. 2022a) reviewed 9 existing SRs with meta-analyses and then performed an updated meta-analysis of 20 RCTs ([Erratum: Pozuelo-Carrascosa et al. 2022b] n = 3,757). The SR compared VAP risk ratio of patients who had ETTs with and without SSD ports for mechanical ventilation.(1,2) We identified but excluded an overlapping SR (Rahimibashar et al. 2019) that did not report comparative outcomes.(3)
  • 1 SR with meta-analysis (Huang et al. 2018, 9 RCTs, n = 1,250) compared ETTs with and without SSD ports for mechanical ventilation in patients who were admitted to intensive care units. Although this SR included 9 of the 20 RCTs in the Pozuelo-Carrascosa et al. SR (2020a, 2020b), we included it because it also reported on specific microorganisms associated with VAP incidence.(4)

RCTs published after the SRs' search dates:

  • 1 single-center RCT (Mahmoodpoor et al. 2020, n = 90) compared an ETT with SSD port (TaperGuard Evac, Medtronic plc., Dublin, Ireland, n = 45) with a silver-coated ETT (Bactiguard, Tullinge, Sweden, n = 45) in adults requiring mechanical ventilation for >48 hours and reported on VAP incidence.(5)
  • 1 single-center RCT (Gunjan et al. 2018, n = 60) compared an ETT with SSD port (n = 30) and a conventional ETT (n = 30) in adults who underwent neurosurgery and required mechanical ventilation for >48 hours. The study reported on VAP incidence.(6)

See Table 1 and 2 for study summaries. We review full text of the included studies available through open access or our library subscriptions.

Findings

We assessed two SRs with meta-analyses (one reported in two publications [original and erratum]) and two RCTs that addressed ETTs with SSD ports' capability for mechanical ventilation and reported on VAP.

Evidence from the SR with meta-analyses of RCTs consistently shows lower VAP incidence in patients who received ETTs with SSD ports for mechanical ventilation than those who received conventional ETTs. See details below.

VAP incidence:

  • The most recent SR (Pozuelo-Carrascosa et al. 2022a and b) reviewed 9 other SRs with meta-analyses and performed an updated meta-analysis of 20 RCTs. In the updated meta-analysis, authors reported lower VAP risk in patients who received ETTs with SSD ports for mechanical ventilation than patients who received conventional ETTs (risk ratio 0.60, 95% confidence interval [CI] 0.53 to 0.68, I2 = 0%). Authors further noted that these results were consistent with the nine prior meta-analyses they analyzed.(2)
  • The Huang et al. 2018 meta-analysis reported on gram-positive cocci and Haemophilus influenzae-associated VAP in patients and found a lower VAP incidence in patients who underwent mechanical ventilation using ETTs with SSD ports than in those who received conventional ETTs (OR 0.29, 95% CI: 0.18 to 0.48). Huang et al. 2018 also found no statistically significant difference in nonfermentative bacteria-associated and enterobacteria-associated VAP incidence between groups that received ETTs with SSD ports and groups that received conventional ETTs for mechanical ventilation (odds ratio 0.73, 95% CI: 0.53 to 1.01).(4)
  • A small RCT published after these meta-analyses found no difference in VAP incidence between groups receiving ETT with or without an SSD port (Gunjan et al. 2018, clinical VAP 12% [3/25] versus 20% [5/25], p = 0.70, microbiological VAP 44% [11/25] versus 52% [13/25], p = 0.78).(6)

ETT with SSD port versus silver-coated ETT:

  • A small, single-center RCT (Mahmoodpoor et al. 2020) reported no statistically significant difference in VAP incidence between an ETT with SSD port group and silver-coated ETT group (20% [9/45] versus 31% [14/45], p = 0.227).(5)

Evidence limitations: Neither of the two small RCTs we reviewed provide conclusive results due to small sample size, single- center focus, and moderate risk of bias. The RCTs in the SRs we reviewed had either a low or unclear risk of bias for each of six potential bias domains examined. Included RCTs were performed in different countries, assessed patients with different etiologies who underwent different surgical procedures, and ETT use was part of bundled VAP preventive measures. These factors may affect generalization and interpretation of results. Additional larger, multicenter RCTs that report VAP from comparisons of ETTs with SSD ports and conventional ETTs, antimicrobial agent-coated ETTs, and ETTs with SSD ports from different manufacturers would be useful to validate findings.  

Table 1. Systematic Reviews
Author/Year Purpose Searches and Inclusion Criteria Findings Reported by Authors Authors' Conclusions

Pozuelo-Carrascosa et al. 2020a(1)

 

Erratum: Pozuelo-Carrascosa et al. 2022b(2)

 

Reviewed full text and erratum

Overview of 9 systematic reviews and an updated meta-analysis “to assess the effectiveness of subglottic secretion drainage (SSD) for preventing VAP [ventilator-associated pneumonia]."

Searched MEDLINE (via PubMed), EMBASE (via Scopus), Cochrane Library, and Web of Science through July 2019 for randomized controlled trials (RCTs) assessing SSD port effectiveness in adults admitted to an intensive care unit (ICU).

Included: 20 RCTs published from 1992 to 2017 (n = 3757)*.

*9 of 20 RCTs overlap with Huang et al. below

From Erratum: “After correction, the new results [from updated meta-analysis] continue to show an association between SSD and lower incidence of VAP (RR 0.60, 95% CI 0.53–0.68, p< 0.001; I2=0%)."

“[SSD] is an effective measure to reduce VAP incidence."

Huang et al. 2018(4)

 

Reviewed full text

 

 

Meta-analysis on the SSD port's influence on the microorganisms of VAP

Searched PubMed, EMBASE, Cochrane Library, Google scholar, China National Knowledge Infrastructure, and VIPI (Database for Chinese Technical Periodicals) through August 2016 for RCTs comparing standard endotracheal tubes (ETT) with ETT with SSD capability in patients who required invasive manual ventilation (MV) and reported on VAP.

Included studies: 9 RCTs published from 1995 through 2010 (n = 2,150).

“There was no significant difference in the rate of VAP caused by nonfermentative bacteria and enterobacteria between SSD group and control group (OR=0.73, 95%CI, 0.53–1.01; p = 0.06). The episodes of VAP caused by Gram-positive cocci and Haemophilus influenzae organisms were lower in the SSD group (OR=0.29, 95%CI, 0.18–0.48; p< 0.00001)."“We found SSD to be associated with significant decreases in VAP caused by Gram-positive cocci and H influenzae organisms but no significant differences in VAP caused by nonfermentative bacteria and enterobacteria."

 

Table 2. Randomized Controlled Trials
Author/Year Study Type and
Patients
Intervention Findings Reported by Authors Authors' Conclusions
Randomized Controlled Trials (RCTs)

Mahmoodpoor et al. 2020(5)

 

Reviewed full text (available only with subscription)

 

Iran

Single-center RCT of 90 patients who require mechanical ventilation for over 48 hoursEndotracheal tube (ETT) with subglottic secretion drainage port (ETTs with SSD port, TaperGuard Evac, n = 45) or Silver-coated ETT (Bactiguard, n = 45)“VAP [ventilator-associated pneumonia] developed in 31% [14/45 patients of the Bactiguard group and 20% [9/45] of the Taperguard group (p = 0.227).“The use of Bactiguard or Taperguard ETTs was not associated with any difference in the incidence of VAP."

Gunjan et al. 2018(6)

 

Reviewed full text

 

India

 

Single-center RCT of 60 adults who underwent neurosurgery and required mechanical ventilation for >48 hoursETTs with SSD ports (n = 30) or standard ETTs (SETT, n = 30)“The incidence of clinical VAP in this study was 20% (5/25) in SETT group and 12% (3/25) in [ETTs with SSD port] group (p = 0.70). The incidence of microbiological VAP was higher in the SETT group (13/25; 52%) as compared to the [ETTs with SSD port] group (11/25; 44%) but not statistically significant (p = 0.78)."“In this study involving neurological population, there was no significant difference in incidence of clinical and microbiological VAP between SETT and [ETTs with SSD port] group, when other strategies for VAP prevention were similar."

Guidelines, Position and Consensus Statements

Searched PubMed, EMBASE, and ECRI Guidelines Trust® (EGT) for relevant documents published January 1, 2017, through July 18, 2022. We identified two documents.

We sought guidelines that are clearly supported by published SRs or included in EGT, a publicly available online repository of guidelines supported by SRs and developed by nationally and internationally recognized medical organizations and specialty societies. These guidelines must meet certain U.S. National Academy of Medicine criteria. We found no guidelines on ETT with SSD ports supported by SRs.

The [ETT] with subglottic suction can reduce the incidence of VAP, and decrease the length of ICU stay…. It is recommended to use such an [ETT] in the patients who are expected to undergo invasive ventilation for more than 48 or 72 hours … (IA [evidence level and recommendation grade]). The cuff pressure should be kept at 25 cmH2O or higher (IA). The subglottic secretions should be removed as clean as possible before balloon deflation or extubation.

The following interventions may lower VAP rates, but current data are insufficient to determine their impact on duration of mechanical ventilation, length of stay, and mortality.

Consider using [ETTs] with [SSD] ports to minimize pooling of secretions above the endotracheal cuff in patients likely to require >48–72 hours of intubation (Quality of Evidence: MODERATE).

This intervention uses [ETTs] with [SSD] ports (Quality of Evidence: LOW).] has not been studied in children and is only feasible for children aged ≥10 years because the smallest available [ETTs] with [SSD] ports is size 6.0.

Glossary

Bibliography

References

References Reviewed (PubMed and EMBASE search dates 2017 Jan 1 through 2022 Jul 18)  

  1. Pozuelo-Carrascosa, DP, Herráiz-Adillo, Á, Alvarez-Bueno, C, Añón, JM, Martínez-Vizcaíno, V, and Cavero-Redondo, I. Subglottic secretion drainage for preventing ventilator-associated pneumonia: an overview of systematic reviews and an updated meta-analysis. Eur Respir Rev. 2020;29(155). PubMed abstract
  2. Pozuelo-Carrascosa, DP, Herráiz-Adillo, Á, Alvarez-Bueno, C, Añón, JM, Martínez-Vizcaíno, V, and Cavero-Redondo, I. Erratum: Subglottic secretion drainage for preventing ventilator-associated pneumonia: an overview of systematic reviews and an updated meta-analysis (Eur Respir Rev, (2020) 29, 190107, 10.1183/16000617.0107-2019). European Respiratory Review. 2022;31:163 Article Number: 195107. PubMed abstract
  3. Rahimibashar, F, Farsi, Z, Danial, Z, Dalvand, S, and Vahedian-Azimi, A. Subglottic secretion drainage to prevent ventilator-associated pneumonia in mechanically ventilated adult patients: A systematic review and meta-analysis. Trauma Monthly. 2019;24:4 Article Number: e88979. PubMed abstract
  4. Huang, XA, Du, YP, Fu, BB, and Li, LX. Influence of subglottic secretion drainage on the microorganisms of ventilator associated pneumonia: A meta-analysis for subglottic secretion drainage. Medicine.2018 97:28 Article Number: e11223. PubMed abstract
  5. Mahmoodpoor, A, Sanaie, S, Parthvi, R, Shadvar, K, Hamishekar, H, Iranpour, A, Nuri, H, Rahnemayan, S, et al. A clinical trial of silver-coated and tapered cuff plus supraglottic suctioning endotracheal tubes in preventing ventilator-associated pneumonia. J Crit Care. 2020;56:171-176. PubMed abstract
  6. Gunjan, Ankesh, Shekhar, S, Akhileshwar, and Kumar, P. Would "Suction above Cuff" be a Better Option than the "Standard" Endotracheal Tube for the Prevention of Ventilator-Associated Pneumonia: A Randomized Study in Postoperative Neurological Patients. Anesth Essays Res. 2018;12(2):480-483. PubMed abstract 

Resource List

Related Resources

ECRI Resources [searched 2017 Jan 1 through 2022 Jul 18].

Search Strategy:

  • endotracheal tubes; subglottic secretion drainage; ventilator associated pneumonia

Universal Medical Device Nomenclature System (UMDNS) Codes:

  • Tubes, Tracheal [14-085]

Results:

PubMed. Bethesda (MD): National Library of Medicine [searched 2017 Jan 1 through 2022 Jul 18]. Available from: http://www.pubmed.gov.

Search Strategy:

  • #1 - "Pneumonia, Ventilator-Associated"[Mesh] OR "ventilator associated pneumonia"
  • #2 - subglott* AND (drain* OR suction*)
  • #3 - microcuff* OR sacett OR shiley OR "suction above cuff endotracheal tube" OR taperguard
  • #4 - #1 AND (#2 OR #3)

EMBASE. Amsterdam (The Netherlands): Elsevier B.V. [searched 2017 Jan 1 through 2022 Jul 18]. Available from: www.embase.com. Subscription required.

Search Strategy:

  • #1 - 'ventilator associated pneumonia'/exp OR "ventilator associated pneumonia"
  • #2 - subglott* AND (drain* OR suction*)
  • #3 - microcuff* OR sacett OR shiley OR 'suction above cuff endotracheal tube' OR taperguard
  • #4 - #1 AND (#2 OR #3)
  • #5 - #4 NOT (('book'/de OR 'case report'/de OR 'conference paper'/exp OR 'editorial'/de OR 'letter'/de OR book:it OR chapter:it OR conference:it OR editorial:it OR letter:it OR [conference abstract]/lim OR [conference paper]/lim OR [conference review]/lim OR [editorial]/lim OR [letter]/lim OR abstract:nc OR annual:nc OR conference:nc OR congress:nc OR meeting:nc OR proceedings:nc OR sessions:nc OR symposium:nc OR book:pt) NOT series:pt OR 'conference proceeding':pt OR 'case report':ti OR comment*:ti OR editorial:ti OR letter:ti OR news:ti OR (protocol:ti AND (study:ti OR trial:ti) NOT ('therapy protocol*':ti OR 'treatment protocol*':ti)))

Guidelines, Position and Consensus Statements [searched 2017 Jan 1 through 2022 Jul 18].

Search Strategy:

  • subglottic secretion drainage; ventilator associated pneumonia

Selected Standards and Guidelines:

Medicare Coverage Database. Baltimore (MD): Centers for Medicare & Medicaid Services [searched 2022 Jul 18]. Available from: https://www.cms.gov/medicare-coverage-database/new-search/search.aspx.

Search Strategy:

  • endotracheal tube; subglottic secretion drainage; ventilator associated pneumonia

Results: We did not identify any national or local pending coverage analyses, determinations, articles, or policies.

Selected Web Resources [searched 2022 Jul 18].

Selected Manufacturers

Other Selected Web Resources

Topics and Metadata

Topics

Technology Selection; Treatment of Disease

Caresetting

Hospital Inpatient; Rehabilitation Facility; Short-stay Facility; Skilled-nursing Facility

Clinical Specialty

Otolaryngology; Pulmonary Medicine

Roles

Clinical Practitioner; Nurse

Information Type

Guidance

Phase of Diffusion

 

Technology Class

Device

Clinical Category

Preventive

SourceBase Supplier

Product Catalog

MeSH

ICD9/ICD10

FDA SPN

SNOMED

HCPCS

Disease/Condition

 

Publication History