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Endotracheal Tube Cuff Pressure Measurement

Sponsor
Bagcilar Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04397952
Collaborator
(none)
30
Enrollment
1
Location
26
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    30 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Comparison of Two Different Measurement of Endotracheal Tube Cuff Pressure for Ventilatory Associated Pnemonia in Severe Brain Injured Patients
    Actual Study Start Date :
    Nov 1, 2017
    Actual Primary Completion Date :
    Apr 15, 2018
    Actual Study Completion Date :
    Jan 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Duration [30 days]

      Follow up duration in ICU

    2. Ventilation [30 days]

      Mechanically ventilated period

    3. Score [48.hour - 72.hour - 96.hour]

      Clinical Pulmonary Infection Score Change from baseline at 48.hour, 72.hour and 96.hour

    4. CRP [48.hour - 72.hour - 96.hour]

      C Reactive Protein measurement change from Baseline at 48.hour, 72.hour and 96.hour

    5. Oxygenation [48.hour - 72.hour - 96.hour]

      Fractional Inspiratory Oxygen levels change from baseline at 48.hour, 72.hour and 96.hour

    6. PEEP [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

    Secondary Outcome Measures

    1. Tracheal aspirate [0.hour - 48.hour - 72.hour - 96.hour]

      Tracheal aspirate sample for culture

    2. Bacterial distribution [0.hour - 48.hour - 72.hour - 96.hour]

      Bacterial distribution of tracheal aspirate culture

    3. Mortality [30 days]

      Total mortality ratio during study period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bagcilar Training and Research Hospital Istanbul Turkey 34200

    Sponsors and Collaborators

    • Bagcilar Training and Research Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bagcilar Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT04397952
    Other Study ID Numbers:
    • 2017.11.1.02.008.r1.010
    First Posted:
    May 21, 2020
    Last Update Posted:
    May 21, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bagcilar Training and Research Hospital
    pneumonia, cuff pressure, brain injury
    Additional relevant MeSH terms:
    Pneumonia
    Pneumonia, Ventilator-Associated
    Brain Injuries, Traumatic

    Study Results

    No Results Posted as of May 21, 2020