Back to resultsAssesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar
Primary Purpose
Respiratory Tract Diseases, Respiratory Tract Infections, Pneumonia, Ventilator-Associated
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
traning seminar
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Tract Diseases focused on measuring endotracheal tube cuff pressure, Ventilator-Induced Lung Injury, traning
Eligibility Criteria
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
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
once a day
three times a day
Arm Description
Cuff pressure checks once a day.
Cuff pressure checks three times a day
Outcomes
Primary Outcome Measures
monitoring of cuff pressures
The effectiveness of pressure monitoring in various time intervals
Secondary Outcome Measures
preventing complications of incorrect pressure in tracheal cuff
preventing of an VAP or airway damage
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03401463
Brief Title
Assesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar
Official Title
Assesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 26, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
July 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jagiellonian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Diseases, Respiratory Tract Infections, Pneumonia, Ventilator-Associated, Ventilator-Induced Lung Injury
Keywords
endotracheal tube cuff pressure, Ventilator-Induced Lung Injury, traning
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
once a day
Arm Type
Active Comparator
Arm Description
Cuff pressure checks once a day.
Arm Title
three times a day
Arm Type
Active Comparator
Arm Description
Cuff pressure checks three times a day
Intervention Type
Other
Intervention Name(s)
traning seminar
Intervention Description
There will be provided 30 min training seminar on the function of endotracheal cuff and cuff pressure.
Primary Outcome Measure Information:
Title
monitoring of cuff pressures
Description
The effectiveness of pressure monitoring in various time intervals
Time Frame
1 year
Secondary Outcome Measure Information:
Title
preventing complications of incorrect pressure in tracheal cuff
Description
preventing of an VAP or airway damage
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
We are undecided on this point.
Learn more about this trial
Assesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar
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