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Completed

NCT Number: NCT04397952

Endotracheal Tube Cuff Pressure Measurement

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

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Key information

Conditions

Ventilator Associated Pneumonia Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Cross Infection Disease Attributes Endotracheal Aspiration Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Morality Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections Trauma, Brain Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bagcilar Training and Research Hospital

Istanbul, 34200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Duration

    Time frame: 30 days

    Follow up duration in ICU

  2. Ventilation

    Time frame: 30 days

    Mechanically ventilated period

  3. Score

    Time frame: 48.hour - 72.hour - 96.hour

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

  4. CRP

    Time frame: 48.hour - 72.hour - 96.hour

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

  5. Oxygenation

    Time frame: 48.hour - 72.hour - 96.hour

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

  6. 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

Secondary outcomes

  1. Tracheal aspirate

    Time frame: 0.hour - 48.hour - 72.hour - 96.hour

    Tracheal aspirate sample for culture

  2. Bacterial distribution

    Time frame: 0.hour - 48.hour - 72.hour - 96.hour

    Bacterial distribution of tracheal aspirate culture

  3. Mortality

    Time frame: 30 days

    Total mortality ratio during study period

Sponsors and collaborators

Lead sponsor

Bagcilar Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
May 21, 2020
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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