Endotracheal Tube Cuff Pressure Measurement

May 20, 2020 updated by: Bagcilar Training and Research Hospital

Comparison of Two Different Measurement of Endotracheal Tube Cuff Pressure for Ventilatory Associated Pnemonia in Severe Brain Injured Patients

The effect of endotracheal cuff pressure measurement technique for preventing ventilatory associated pneumonia.

Study Overview

Status

Completed

Conditions

Detailed Description

Aim of this study is to evaluate the effect of endotracheal cuff pressure measurement technique for preventing ventilatory associated pneumonia of severe traumatic brain injured patients in a tertiary level intensive care unit.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34200
        • Bagcilar Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who followed up in a tertiary intensive care unit diagnosed with traumatic brain injury and under mechanical ventilation.

Description

Inclusion Criteria:

Patients with ASA classification of 1 - 2- 3 patients Patients required mechanical ventilation support for more than 48 hours Patients diagnosed with Traumatic brain injury

Exclusion Criteria:

Official patient relatives who rejected to give informed consent for the study Patients diagnosed with aspiration pneumonia during ICU follow up Patients diagnosed with Acute Respiratory Distress Syndrome Patients diagnosed with cavitary lung lesion Primary lung cancer Metastatic lung cancer Congenitally immune deficiency Leukopenia Neutropenia Tracheostomized patients Post cardiopulmonary arrest patients Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration
Time Frame: 30 days
Follow up duration in ICU
30 days
Ventilation
Time Frame: 30 days
Mechanically ventilated period
30 days
Score
Time Frame: 48.hour - 72.hour - 96.hour
Clinical Pulmonary Infection Score Change from baseline at 48.hour, 72.hour and 96.hour
48.hour - 72.hour - 96.hour
CRP
Time Frame: 48.hour - 72.hour - 96.hour
C Reactive Protein measurement change from Baseline at 48.hour, 72.hour and 96.hour
48.hour - 72.hour - 96.hour
Oxygenation
Time Frame: 48.hour - 72.hour - 96.hour
Fractional Inspiratory Oxygen levels change from baseline at 48.hour, 72.hour and 96.hour
48.hour - 72.hour - 96.hour
PEEP
Time Frame: 48.hour - 72.hour - 96.hour
Positive End Expiratory Pressure levels change from baseline at 48.hour, 72.hour and 96.hour during ventilatory support
48.hour - 72.hour - 96.hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tracheal aspirate
Time Frame: 0.hour - 48.hour - 72.hour - 96.hour
Tracheal aspirate sample for culture
0.hour - 48.hour - 72.hour - 96.hour
Bacterial distribution
Time Frame: 0.hour - 48.hour - 72.hour - 96.hour
Bacterial distribution of tracheal aspirate culture
0.hour - 48.hour - 72.hour - 96.hour
Mortality
Time Frame: 30 days
Total mortality ratio during study period
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bagcilar Training and Research Hospital

Investigators

  • Principal Investigator: Salih SS Sevdi, MD, Univesity of Health Sciences Bagcilar Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

April 15, 2018

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

January 20, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

May 21, 2020

Last Update Submitted That Met QC Criteria

May 20, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017.11.1.02.008.r1.010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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