Endotracheal Tube Cuff Pressure Measurement

Completed

• Conditions: Trauma, Brain; Ventilator Associated Pneumonia; Endotracheal Aspiration; Morality

• Registration Number: NCT04397952
• Lead Sponsor: Bagcilar Training and Research Hospital

Brief Summary

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

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 Timeline

• Study Start: 2017-11-01
• Primary Completion: 2018-04-15
• Study Completion: 2020-01-01
• Study First Submitted: 2020-01-20
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-20
• Last Update Submitted: 2020-05-20
• Study First Posted: 2020-05-21
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Score	48.hour - 72.hour - 96.hour	Clinical Pulmonary Infection Score Change from baseline at 48.hour, 72.hour and 96.hour
CRP	48.hour - 72.hour - 96.hour	C Reactive Protein measurement change from Baseline at 48.hour, 72.hour and 96.hour
Oxygenation	48.hour - 72.hour - 96.hour	Fractional Inspiratory Oxygen levels change from baseline at 48.hour, 72.hour and 96.hour
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
Duration	30 days	Follow up duration in ICU
Ventilation	30 days	Mechanically ventilated period

Secondary Outcome Measures

Name	Time	Method
Tracheal aspirate	0.hour - 48.hour - 72.hour - 96.hour	Tracheal aspirate sample for culture
Mortality	30 days	Total mortality ratio during study period
Bacterial distribution	0.hour - 48.hour - 72.hour - 96.hour	Bacterial distribution of tracheal aspirate culture

Trial Locations

Locations (1)

Bagcilar Training and Research Hospital; 🇹🇷 Istanbul, Turkey