Endotracheal Tube Cuff Pressure Measurement

Ventilator Associated Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04397952
• Other study ID #: 2017.11.1.02.008.r1.010
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: May 2020
• Source: Bagcilar Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 1, 2020
• Est. primary completion date: April 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries, Traumatic
• Endotracheal Aspiration
• Morality
• Pneumonia
• Pneumonia, Ventilator-Associated
• Trauma, Brain
• Ventilator Associated Pneumonia

Locations

Country	Name	City	State
Turkey	Bagcilar Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bagcilar Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration	Follow up duration in ICU	30 days
Primary	Ventilation	Mechanically ventilated period	30 days
Primary	Score	Clinical Pulmonary Infection Score Change from baseline at 48.hour, 72.hour and 96.hour	48.hour - 72.hour - 96.hour
Primary	CRP	C Reactive Protein measurement change from Baseline at 48.hour, 72.hour and 96.hour	48.hour - 72.hour - 96.hour
Primary	Oxygenation	Fractional Inspiratory Oxygen levels change from baseline at 48.hour, 72.hour and 96.hour	48.hour - 72.hour - 96.hour
Primary	PEEP	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	Tracheal aspirate	Tracheal aspirate sample for culture	0.hour - 48.hour - 72.hour - 96.hour
Secondary	Bacterial distribution	Bacterial distribution of tracheal aspirate culture	0.hour - 48.hour - 72.hour - 96.hour
Secondary	Mortality	Total mortality ratio during study period	30 days