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

• Sponsor: Jagiellonian University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03401463
• Collaborator: (none)
• Enrollment: 188
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.3
• Patients Per Site Per Month: 22.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Tract Diseases; Respiratory Tract Infections; Pneumonia, Ventilator-Associated; Ventilator-Induced Lung Injury	Other: traning seminar	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 188 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The study will include patients staying in the intensive care unit, requiring ventilation of the artificial airways in the form of endotracheal or tracheostomy tube. Patients will be over 18 years of age.The study will include patients staying in the intensive care unit, requiring ventilation of the artificial airways in the form of endotracheal or tracheostomy tube. Patients will be over 18 years of age.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Assesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar
• Actual Study Start Date: Oct 26, 2017
• Actual Primary Completion Date: Jun 30, 2018
• Actual Study Completion Date: Jul 5, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. monitoring of cuff pressures [1 year]

   The effectiveness of pressure monitoring in various time intervals

Secondary Outcome Measures

1. preventing complications of incorrect pressure in tracheal cuff [5 years]

   preventing of an VAP or airway damage

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Kraków		Poland	31-501

Sponsors and Collaborators

• Jagiellonian University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tomasz Skladzien, MD PhD, Principal Investigator, Jagiellonian University
• ClinicalTrials.gov Identifier: NCT03401463
• Other Study ID Numbers: 1072.6120.194.2017
• First Posted: Jan 17, 2018
• Last Update Posted: Jul 31, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tomasz Skladzien, MD PhD, Principal Investigator, Jagiellonian University: endotracheal tube cuff pressure; Ventilator-Induced Lung Injury; traning
• Additional relevant MeSH terms: Respiratory Tract Infections; Pneumonia, Ventilator-Associated; Lung Injury; Respiratory Tract Diseases; Ventilator-Induced Lung Injury

Study Results

No Results Posted as of Jul 31, 2018