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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03401463
Other study ID # 1072.6120.194.2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 26, 2017
Est. completion date July 5, 2018

Study information

Verified date July 2018
Source Jagiellonian University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 188
Est. completion date July 5, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
traning seminar
There will be provided 30 min training seminar on the function of endotracheal cuff and cuff pressure.

Locations

Country Name City State
Poland University Hospital Kraków

Sponsors (1)

Lead Sponsor Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary monitoring of cuff pressures The effectiveness of pressure monitoring in various time intervals 1 year
Secondary preventing complications of incorrect pressure in tracheal cuff preventing of an VAP or airway damage 5 years
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