Endotracheal Tube Cuff Pressure Measurement

NCT04397952 | Completed

• 1 other identifier: 2017.11.1.02.008.r1.010
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ventilator Associated Pneumonia; Morality; Trauma, Brain; Endotracheal Aspiration

Keywords

pneumonia, cuff pressure, brain injury

Outcome Measures

Primary Outcomes (6)

• Duration

  Follow up duration in ICU

  30 days

• Ventilation

  Mechanically ventilated period

  30 days

• Score

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

  48.hour - 72.hour - 96.hour

• CRP

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

  48.hour - 72.hour - 96.hour

• Oxygenation

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

  48.hour - 72.hour - 96.hour

• 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 Outcomes (3)

• Tracheal aspirate

  0.hour - 48.hour - 72.hour - 96.hour

• Bacterial distribution

  0.hour - 48.hour - 72.hour - 96.hour

• Mortality

  30 days

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bagcilar Training and Research Hospital: lead

Study Sites (1)

Bagcilar Training and Research Hospital

Istanbul, 34200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Brain Injuries, Traumatic; Pneumonia; Brain Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Salih SS Sevdi, MD

  Univesity of Health Sciences Bagcilar Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: May 21, 2020
• Study Start: November 1, 2017
• Primary Completion: April 15, 2018
• Study Completion: January 1, 2020
• Last Updated: May 21, 2020

Record last verified: 2020-05

Locations

TU (1)