Endotracheal Tube Cuff Pressures in Ventilated Patients

NCT02950519 | Completed

• 1 other identifier: 201605155
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 1

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).

Conditions

Pneumonia, Ventilator-Associated

Outcome Measures

Primary Outcomes (1)

• Ventilator Associated Condition (VAC) as defined by CDC

  Lung Condition that developed in association with mechanical ventilation

  48 hours after intubation

Secondary Outcomes (3)

• Length of stay (hospital)

  Time in days of hospital stay for patients admitted and discharged for a period up to 6 months

• Hospital mortality

  Any time during hospitalization up to a period of 6 months

• Ventilator Associated Pneumonia (VAP)

  48 hrs after intubation

Study Arms (2)

As needed Cuff Pressure Checks

ACTIVE COMPARATOR

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

Other: monitoring of cuff pressures

Cuff Pressure checks every 8 hrs

EXPERIMENTAL

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

Other: monitoring of cuff pressures

Interventions

monitoring of cuff pressures OTHER

Cuff pressure will be checked per standard and additionally a minimum of every 8 hours.

As needed Cuff Pressure Checks; Cuff Pressure checks every 8 hrs

Eligibility Criteria

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

You may qualify if:

• Mechanically ventilated patients intubated in a medical intensive care unit

You may not qualify if:

• Patient requiring prone positioning, lung transplant and neutropenic patients

Sponsors & Collaborators

• Barnes-Jewish Hospital: lead

Study Sites (1)

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

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

Study Officials

• Marin Kollef, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MS

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: November 1, 2016
• Study Start: October 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 18, 2018

Record last verified: 2018-01

Locations

US (1)