Assesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar

There is no accepted standard for the frequency of monitoring endotracheal tube cuff pressures (ETCP). the investigators plan on comparing two strategies for monitoring ETCP in mechanically ventilated patients.

Nowadays ETCP is evaluated once every 24 hours. Next, the investigator want to conduct training for medical and nursing staff. After the training, ETCP will be measured every 8 hours.

The aim of the study is to prove that more frequent pressure control (3 times a day) reduces the occurrence of abnormal ETCP.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections; Respiratory Tract Diseases; Ventilator-Induced Lung Injury; Pneumonia, Ventilator-Associated
• Intervention / Treatment: Other: traning seminar

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Kraków, Poland, 31-501
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Mechanically ventilated patients intubated in a medical intensive care unit

Exclusion Criteria:

• Patient requiring prone positioning, tracheo-esophageal fistula, lung transplant and neutropenic patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: once a day; Cuff pressure checks once a day.	Other: traning seminar; There will be provided 30 min training seminar on the function of endotracheal cuff and cuff pressure.
Active Comparator: three times a day; Cuff pressure checks three times a day	Other: traning seminar; There will be provided 30 min training seminar on the function of endotracheal cuff and cuff pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
monitoring of cuff pressures	The effectiveness of pressure monitoring in various time intervals	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
preventing complications of incorrect pressure in tracheal cuff	preventing of an VAP or airway damage	5 years

Collaborators and Investigators

• Sponsor: Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): July 5, 2018

Study Registration Dates

• First Submitted: January 3, 2018
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 28, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Ventilator-Induced Lung Injury; endotracheal tube cuff pressure; traning
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Pneumonia; Lung Diseases; Wounds and Injuries; Disease Attributes; Cross Infection; Iatrogenic Disease; Thoracic Injuries; Healthcare-Associated Pneumonia; Respiratory Tract Infections; Lung Injury; Pneumonia, Ventilator-Associated; Respiratory Tract Diseases; Ventilator-Induced Lung Injury
• Other Study ID Numbers: 1072.6120.194.2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: We are undecided on this point.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No