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Endotracheal Tube Cuff Pressures in Ventilated Patients

Primary Purpose

Pneumonia, Ventilator-Associated

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
monitoring of cuff pressures
Sponsored by
Barnes-Jewish Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Ventilator-Associated

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mechanically ventilated patients intubated in a medical intensive care unit

Exclusion Criteria:

  • Patient requiring prone positioning, lung transplant and neutropenic patients

Sites / Locations

  • Barnes-Jewish Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

As needed Cuff Pressure Checks

Cuff Pressure checks every 8 hrs

Arm Description

Cuff pressure checks upon intubation and after any manipulation of ET tube

Cuff pressure checks upon intubation, after manipulation of ET tube, and minimum of 8 hr interval

Outcomes

Primary Outcome Measures

Ventilator Associated Condition (VAC) as defined by CDC
Lung Condition that developed in association with mechanical ventilation

Secondary Outcome Measures

Length of stay (hospital)
Through hospital admission until hospital discharge for patients admitted and discharged for a period up to 6 months
Hospital mortality
Through hospital admission until hospital discharge up to a period of 6 months
Ventilator Associated Pneumonia (VAP)
Pneumonia that developed in association with mechanical ventilation

Full Information

First Posted
October 6, 2016
Last Updated
January 16, 2018
Sponsor
Barnes-Jewish Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02950519
Brief Title
Endotracheal Tube Cuff Pressures in Ventilated Patients
Official Title
Assessing Endotracheal Tube Cuff Pressures in Mechanically Ventilated Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barnes-Jewish Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
There is no accepted standard for the frequency of monitoring endotracheal tube cuff pressures (ETCP). Investigators plan on comparing two strategies for monitoring ETCP in mechanically ventilated patients. The two strategies will be the currently employed practice at Barnes-Jewish Hospital (BJH) which requires ETCP to be assessed immediately after the endotracheal tube is placed and after any manipulation of the endotracheal tube to include repositioning, manipulation of the cuff volume, or presence of an audible leak. Investigator will compare this current practice to a more intensive monitoring of ETCP which is employed at some hospitals and includes the same elements as noted in the current practice plus monitoring ETCP every work shift (every 8 hours or three times per day).
Detailed Description
There is no accepted standard for the frequency of monitoring endotracheal tube cuff pressures (ETCP). Investigator plans on comparing two strategies for monitoring ETCP in mechanically ventilated patients. The two strategies will be the currently employed practice at Barnes-Jewish Hospital (BJH) which requires ETCP to be assessed immediately after the endotracheal tube is placed and after any manipulation of the endotracheal tube to include repositioning, manipulation of the cuff volume, or presence of an audible leak. The alternate practice will be pre-scheduled as is performed at other hospitals and includes the same elements as noted in the current practice but also require monitoring ETCP a minimum of every work shift (every 8 hours or three times per day). The ETCP will be assessed using a standard manometer. The two practices will be compared by assessing patients assigned to odd and even beds in the medical ICU (8400 ICU) with alternate methods. Specifically, patients in odd numbered rooms will have ETCP checked per the current Barnes-Jewish practice and those in even rooms having the additional checks of ETCP performed immediately following intubation as well as every shift and when when assessed required by respiratory therapist. It is important to note that the respiratory therapists performing ETCP assessments are simply performing a routine 2- 3 minute task (per cuff pressure measurement) while taking care of patients on mechanical ventilation. Our hypothesis is that increased monitoring frequency of ETCP will not result in a decrease in the duration of mechanical ventilation for patients admitted to the medical intensive care unit (ICU) of BJH or a reduction in ventilator-associated events. Currently there is no accepted gold standard for the frequency of monitoring ETCP. There are widely different strategies reported for monitoring ETCP to include continuous monitoring. The goal of ETCP monitoring is to maintain the ETCP between 20-30 cmH2O in order to minimize cuff leaks and pressure injury to the tracheal mucosa. It is known that 20 to 30% of the time the ETCP may deviate above or below this threshold. However, the impact of such deviation on clinical outcomes is not well described in the medical literature. The two most common methods for assessing ETCP is the use of a manometer and/or setting a minimal leak, with the former being the most accepted method. However, the optimal frequency for conducting manometric monitoring of ETCP is unknown. One recent study suggests that the act of measuring ETCP frequently in order to achieve a desired pressure level results in the removal of air from the cuff and can result in under inflation of the cuff. However, a recent animal study suggests that the material used to manufacture the endotracheal tube cuff may play a more important role in determining the presence or absence of mucosal injury, with polyurethane being better than polyvinylchloride. The main problem with these studies is the failure to assess clinical outcomes at the bedside with the use of various strategies to maintain an appropriate endotracheal tube cuff seal. A recent survey of intensivists in Queensland Australia and accompanying systematic literature review made the following conclusions regarding ETCP monitoring: "Twenty-eight out of twenty-nine respondents reported routinely monitoring tracheal cuff function, primarily employing cuff pressure measurement (26/28). Target cuff pressures varied, with 3/26 respondents aiming for 10 to 20 cmH2O, 10/26 for 21 to 25 cmH2O, and 13/26 for 26 to 30 cmH2O. Fifteen out of twenty-nine reported they had no current guideline or protocol for tracheal cuff management and only 16/29 indicated there was a dedicated area in the clinical record for reporting cuff intervention. The results indicated that many ICUs across Queensland routinely measure tracheal cuff function, with most utilising pressure monitoring devices. Consistent with existing literature, the optimum cuff pressure remains uncertain. Most, however, considered that this should be a routine part of ICU care". Thus, the available literature on ETCP and their relationship to clinical outcomes is lacking.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Ventilator-Associated

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
305 (Actual)

8. Arms, Groups, and Interventions

Arm Title
As needed Cuff Pressure Checks
Arm Type
Active Comparator
Arm Description
Cuff pressure checks upon intubation and after any manipulation of ET tube
Arm Title
Cuff Pressure checks every 8 hrs
Arm Type
Experimental
Arm Description
Cuff pressure checks upon intubation, after manipulation of ET tube, and minimum of 8 hr interval
Intervention Type
Other
Intervention Name(s)
monitoring of cuff pressures
Intervention Description
Cuff pressure will be checked per standard and additionally a minimum of every 8 hours.
Primary Outcome Measure Information:
Title
Ventilator Associated Condition (VAC) as defined by CDC
Description
Lung Condition that developed in association with mechanical ventilation
Time Frame
48 hours after intubation
Secondary Outcome Measure Information:
Title
Length of stay (hospital)
Description
Through hospital admission until hospital discharge for patients admitted and discharged for a period up to 6 months
Time Frame
Time in days of hospital stay for patients admitted and discharged for a period up to 6 months
Title
Hospital mortality
Description
Through hospital admission until hospital discharge up to a period of 6 months
Time Frame
Any time during hospitalization up to a period of 6 months
Title
Ventilator Associated Pneumonia (VAP)
Description
Pneumonia that developed in association with mechanical ventilation
Time Frame
48 hrs after intubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mechanically ventilated patients intubated in a medical intensive care unit Exclusion Criteria: Patient requiring prone positioning, lung transplant and neutropenic patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marin Kollef, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We are undecided on this point.

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Endotracheal Tube Cuff Pressures in Ventilated Patients

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