Endotracheal Tubes for Prevention of Ventilator-associated Pneumonia

NCT01744483 | Completed Results DMC

• 2 other identifiers: 422305R34HL105581-02
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers are looking at three different types of breathing tubes to see if any of them are better at preventing pneumonia than the others. Two of the tubes have design features to prevent leakage of fluids from the mouth and throat into the lungs. This is importance, since leakage of small amounts of fluid into the lungs may lead to pneumonia. The third tube is the standard tube used at most hospitals. The hypothesis is that the use of a breathing tube that reduces fluid leakage into the lungs will reduce the risk of developing pneumonia, compared to the standard tube. The study will also look at the safety of the modified breathing tubes, compared to the standard tube. This study is a small, "pilot" study that will determine if it is possible to perform a larger study that will provide more certain results.

Conditions

Ventilator-acquired Pneumonia

Keywords

pneumonia; endotracheal intubation

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Tracheal Bacterial Colonization

  The percentage of patients with quantitative culture growth from tracheal aspirate specimens of \>1,000,000 CFU between Day 2 and Day 4 of tracheal intubation/mechanical ventilation. Percentage of patients will be compared between the three study arms.

  Tracheal colonization by Day 4 or extubation

Study Arms (3)

PVC ETT

ACTIVE COMPARATOR

Polyvinylchloride cuff endotracheal tube

Device: PVC ETT

PUC ETT

EXPERIMENTAL

Polyurethane cuff endotracheal tube

Device: PUC ETT

PUC-CASS ETT

EXPERIMENTAL

Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube

Device: PUC-CASS ETT

Interventions

PVC ETT DEVICE

Placement of a PVC-cuffed ETT in the setting of emergent intubation.

Also known as: Mallinckrodt Hi-Lo Oral/Nasal ETT Cuffed. Murphy Eye.

PVC ETT

PUC ETT DEVICE

Placement of a PUC-cuffed ETT in the setting of emergent intubation.

Also known as: Mallinckrodt Seal Guard, oral/nasal ETT.

PUC ETT

PUC-CASS ETT DEVICE

Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation.

Also known as: Mallincrodt Evac Oral ETT, Seal Guard, Murphy Eye

PUC-CASS ETT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older;
• Emergency intubation with a study device either in the field by Medic One, (the Seattle Fire Department program that provides basic and advanced life support services to the city) or at HMC;
• Absence of out-of-hospital cardiac arrest;
• Absence of major burns, penetrating trauma or absence any major trauma with systolic blood pressure \< 90 mmHg at the time of tracheal intubation.

You may not qualify if:

• Use of a non-study designated intubation device (such as nasal intubation, tracheostomy, intubation in the operating room, intubation outside the study network such as occurring in an outside hospital or by other emergency response providers);
• Patients with permanent tracheostomy;
• Federally protected populations: Children (age \<18 years), pregnant women, and prisoners.

Sponsors & Collaborators

• University of Washington: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Deem S, Yanez D, Sissons-Ross L, Broeckel JA, Daniel S, Treggiari M. Randomized Pilot Trial of Two Modified Endotracheal Tubes To Prevent Ventilator-associated Pneumonia. Ann Am Thorac Soc. 2016 Jan;13(1):72-80. doi: 10.1513/AnnalsATS.201506-346OC.

  PMID: 26523433 DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Pneumonia

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Miriam Treggiari
• Organization: Oregon Health Science & Science University

treggiar@ohsu.edu

(503) 494-8311

Study Officials

• Miriam Treggiari, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: December 6, 2012
• Study Start: December 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: February 1, 2016
• Last Updated: October 26, 2017
• Results First Posted: June 12, 2017

Record last verified: 2017-09

Locations

US (1)