Randomized pilot trial of two modified endotracheal tubes to prevent ventilator-associated pneumonia

Steven Deem, Norbert Yanez, Laura Sissons-Ross, Jo Ann Elrod Broeckel, Stephen Daniel, Miriam Treggiari

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Rationale: Ventilator-associated pneumonia (VAP) is a prevalent and costly nosocomial infection related to instrumentation of the airway with an endotracheal tube (ETT), enabling microaspiration of contaminated secretions. Modification of the ETT design to reduce microaspiration and/or biofilm formation may play an important role in VAP prevention. However, there is insufficient evidence to provide strong recommendations regarding the use of modified ETT and unaddressed safety concerns. Objectives: We performed a pilot randomized controlled trial comparing two modified ETTs designed specifically to prevent VAP, with the standard ETT, to test the feasibility of and inform planning for a large, pivotal, randomized trial. Methods: This study was conducted with institutional review board approval under exception from informed consent.Werandomized in a blinded fashion patients undergoing emergency endotracheal intubation both out of and in hospital to receive one of three different ETT types: (1) a polyurethane-cuffed tube (PUC-ETT), (2) a polyurethane-cuffed tube equipped with a port for continuous aspiration of subglottic secretions (PUC-CASS-ETT), or a (3) standard polyvinylchloride-cuffed tube (PVC-ETT). In addition to investigating feasibility and safety, the study coprimary end points were tracheal bacterial colonization reaching a cfu count .106 cfu per milliliter and the incidence of invasively diagnosed VAP. Measurements and Main Results: A total of 102 subjects were randomized and met the eligibility criteria. Randomization procedures performed well and integrity of blinding at randomization was maintained. The majority of intubations occurred in the hospital setting (n = 77), and the remainder occurred out of hospital (n = 25). Compared with the PVC-ETT, there were no significant differences in tracheal colonization for PUC-ETT (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.31-3.09) or for PUC-CASS-ETT (OR, 1.26; 95% CI, 0.42-3.76). There were no differences in the risk of invasively diagnosed VAP (OR, 1.14; 95% CI, 0.21-6.08 for PUC-ETT; OR, 1.47; 95% CI, 0.30-7.10 for PUC-CASS-ETT), or of clinically diagnosed VAP by either clinical signs or chest radiograph criteria. We did not observe unexpected or serious adverse events related to the devices. Conclusions: A randomized trial of ETTs inserted during emergency intubation for the prevention of VAP is feasible and did not appear to carry heightened safety concerns. These preliminary data did not suggest different patterns of tracheal colonization or occurrence of VAP among the study groups. Clinical trial registered with www.clinicaltrials.gov (NCT01744483).

Original languageEnglish (US)
Pages (from-to)72-80
Number of pages9
JournalAnnals of the American Thoracic Society
Volume13
Issue number1
DOIs
StatePublished - Jan 1 2016

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Ventilator-Associated Pneumonia
Odds Ratio
Confidence Intervals
Polyurethanes
Random Allocation
Safety
Polyvinyl Chloride
Intubation
Emergencies
Intratracheal Intubation
Research Ethics Committees
Feasibility Studies
Biofilms
Cross Infection
Informed Consent
Thorax
Randomized Controlled Trials
Clinical Trials
Equipment and Supplies
Incidence

Keywords

  • Clinical trial
  • Microaspiration
  • Nosocomial pneumonia
  • Subglottic suction

ASJC Scopus subject areas

  • Medicine(all)
  • Pulmonary and Respiratory Medicine

Cite this

Randomized pilot trial of two modified endotracheal tubes to prevent ventilator-associated pneumonia. / Deem, Steven; Yanez, Norbert; Sissons-Ross, Laura; Broeckel, Jo Ann Elrod; Daniel, Stephen; Treggiari, Miriam.

In: Annals of the American Thoracic Society, Vol. 13, No. 1, 01.01.2016, p. 72-80.

Research output: Contribution to journalArticle

Deem, Steven ; Yanez, Norbert ; Sissons-Ross, Laura ; Broeckel, Jo Ann Elrod ; Daniel, Stephen ; Treggiari, Miriam. / Randomized pilot trial of two modified endotracheal tubes to prevent ventilator-associated pneumonia. In: Annals of the American Thoracic Society. 2016 ; Vol. 13, No. 1. pp. 72-80.
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abstract = "Rationale: Ventilator-associated pneumonia (VAP) is a prevalent and costly nosocomial infection related to instrumentation of the airway with an endotracheal tube (ETT), enabling microaspiration of contaminated secretions. Modification of the ETT design to reduce microaspiration and/or biofilm formation may play an important role in VAP prevention. However, there is insufficient evidence to provide strong recommendations regarding the use of modified ETT and unaddressed safety concerns. Objectives: We performed a pilot randomized controlled trial comparing two modified ETTs designed specifically to prevent VAP, with the standard ETT, to test the feasibility of and inform planning for a large, pivotal, randomized trial. Methods: This study was conducted with institutional review board approval under exception from informed consent.Werandomized in a blinded fashion patients undergoing emergency endotracheal intubation both out of and in hospital to receive one of three different ETT types: (1) a polyurethane-cuffed tube (PUC-ETT), (2) a polyurethane-cuffed tube equipped with a port for continuous aspiration of subglottic secretions (PUC-CASS-ETT), or a (3) standard polyvinylchloride-cuffed tube (PVC-ETT). In addition to investigating feasibility and safety, the study coprimary end points were tracheal bacterial colonization reaching a cfu count .106 cfu per milliliter and the incidence of invasively diagnosed VAP. Measurements and Main Results: A total of 102 subjects were randomized and met the eligibility criteria. Randomization procedures performed well and integrity of blinding at randomization was maintained. The majority of intubations occurred in the hospital setting (n = 77), and the remainder occurred out of hospital (n = 25). Compared with the PVC-ETT, there were no significant differences in tracheal colonization for PUC-ETT (odds ratio [OR], 0.98; 95{\%} confidence interval [CI], 0.31-3.09) or for PUC-CASS-ETT (OR, 1.26; 95{\%} CI, 0.42-3.76). There were no differences in the risk of invasively diagnosed VAP (OR, 1.14; 95{\%} CI, 0.21-6.08 for PUC-ETT; OR, 1.47; 95{\%} CI, 0.30-7.10 for PUC-CASS-ETT), or of clinically diagnosed VAP by either clinical signs or chest radiograph criteria. We did not observe unexpected or serious adverse events related to the devices. Conclusions: A randomized trial of ETTs inserted during emergency intubation for the prevention of VAP is feasible and did not appear to carry heightened safety concerns. These preliminary data did not suggest different patterns of tracheal colonization or occurrence of VAP among the study groups. Clinical trial registered with www.clinicaltrials.gov (NCT01744483).",
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T1 - Randomized pilot trial of two modified endotracheal tubes to prevent ventilator-associated pneumonia

AU - Deem, Steven

AU - Yanez, Norbert

AU - Sissons-Ross, Laura

AU - Broeckel, Jo Ann Elrod

AU - Daniel, Stephen

AU - Treggiari, Miriam

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N2 - Rationale: Ventilator-associated pneumonia (VAP) is a prevalent and costly nosocomial infection related to instrumentation of the airway with an endotracheal tube (ETT), enabling microaspiration of contaminated secretions. Modification of the ETT design to reduce microaspiration and/or biofilm formation may play an important role in VAP prevention. However, there is insufficient evidence to provide strong recommendations regarding the use of modified ETT and unaddressed safety concerns. Objectives: We performed a pilot randomized controlled trial comparing two modified ETTs designed specifically to prevent VAP, with the standard ETT, to test the feasibility of and inform planning for a large, pivotal, randomized trial. Methods: This study was conducted with institutional review board approval under exception from informed consent.Werandomized in a blinded fashion patients undergoing emergency endotracheal intubation both out of and in hospital to receive one of three different ETT types: (1) a polyurethane-cuffed tube (PUC-ETT), (2) a polyurethane-cuffed tube equipped with a port for continuous aspiration of subglottic secretions (PUC-CASS-ETT), or a (3) standard polyvinylchloride-cuffed tube (PVC-ETT). In addition to investigating feasibility and safety, the study coprimary end points were tracheal bacterial colonization reaching a cfu count .106 cfu per milliliter and the incidence of invasively diagnosed VAP. Measurements and Main Results: A total of 102 subjects were randomized and met the eligibility criteria. Randomization procedures performed well and integrity of blinding at randomization was maintained. The majority of intubations occurred in the hospital setting (n = 77), and the remainder occurred out of hospital (n = 25). Compared with the PVC-ETT, there were no significant differences in tracheal colonization for PUC-ETT (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.31-3.09) or for PUC-CASS-ETT (OR, 1.26; 95% CI, 0.42-3.76). There were no differences in the risk of invasively diagnosed VAP (OR, 1.14; 95% CI, 0.21-6.08 for PUC-ETT; OR, 1.47; 95% CI, 0.30-7.10 for PUC-CASS-ETT), or of clinically diagnosed VAP by either clinical signs or chest radiograph criteria. We did not observe unexpected or serious adverse events related to the devices. Conclusions: A randomized trial of ETTs inserted during emergency intubation for the prevention of VAP is feasible and did not appear to carry heightened safety concerns. These preliminary data did not suggest different patterns of tracheal colonization or occurrence of VAP among the study groups. Clinical trial registered with www.clinicaltrials.gov (NCT01744483).

AB - Rationale: Ventilator-associated pneumonia (VAP) is a prevalent and costly nosocomial infection related to instrumentation of the airway with an endotracheal tube (ETT), enabling microaspiration of contaminated secretions. Modification of the ETT design to reduce microaspiration and/or biofilm formation may play an important role in VAP prevention. However, there is insufficient evidence to provide strong recommendations regarding the use of modified ETT and unaddressed safety concerns. Objectives: We performed a pilot randomized controlled trial comparing two modified ETTs designed specifically to prevent VAP, with the standard ETT, to test the feasibility of and inform planning for a large, pivotal, randomized trial. Methods: This study was conducted with institutional review board approval under exception from informed consent.Werandomized in a blinded fashion patients undergoing emergency endotracheal intubation both out of and in hospital to receive one of three different ETT types: (1) a polyurethane-cuffed tube (PUC-ETT), (2) a polyurethane-cuffed tube equipped with a port for continuous aspiration of subglottic secretions (PUC-CASS-ETT), or a (3) standard polyvinylchloride-cuffed tube (PVC-ETT). In addition to investigating feasibility and safety, the study coprimary end points were tracheal bacterial colonization reaching a cfu count .106 cfu per milliliter and the incidence of invasively diagnosed VAP. Measurements and Main Results: A total of 102 subjects were randomized and met the eligibility criteria. Randomization procedures performed well and integrity of blinding at randomization was maintained. The majority of intubations occurred in the hospital setting (n = 77), and the remainder occurred out of hospital (n = 25). Compared with the PVC-ETT, there were no significant differences in tracheal colonization for PUC-ETT (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.31-3.09) or for PUC-CASS-ETT (OR, 1.26; 95% CI, 0.42-3.76). There were no differences in the risk of invasively diagnosed VAP (OR, 1.14; 95% CI, 0.21-6.08 for PUC-ETT; OR, 1.47; 95% CI, 0.30-7.10 for PUC-CASS-ETT), or of clinically diagnosed VAP by either clinical signs or chest radiograph criteria. We did not observe unexpected or serious adverse events related to the devices. Conclusions: A randomized trial of ETTs inserted during emergency intubation for the prevention of VAP is feasible and did not appear to carry heightened safety concerns. These preliminary data did not suggest different patterns of tracheal colonization or occurrence of VAP among the study groups. Clinical trial registered with www.clinicaltrials.gov (NCT01744483).

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KW - Microaspiration

KW - Nosocomial pneumonia

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