- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04877353
Postoperative Noninvasive Ventilation After Upper Abdominal Surgery in Chronic Obstructive Lung Disease
May 3, 2021 updated by: Asmaa Mohamed, South Valley University
In Qena university hospital a prospective, randomized study was carried out on 100 COPD patients, all were divided into; conventional therapy without NIV (C group) 50 patients or with prophylactic NIV(N group) 50 patients.NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery .
Primary endpoint was the acute respiratory events (ARE) .Secondary endpoints were acute respiratory failure (ARF), intubation rate, mortality rate, infectious and non-infectious complications, and ICU stay.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Luxor, Egypt, 85951
- asmaa Mostafa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Age˃18 years, scheduled for upper abdominal surgery under general anesthesia.
- Moderate to very severe COPD (GOLD II to IV).
- ASA functional status II or greater.
Exclusion criteria:
- Contraindications to the application of NIV.
- Sleep apnea syndrome.
- Facial deformation.
- Inability to follow the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group N
50 patients.NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery
|
NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery
|
No Intervention: group C
50 patients recieved conventional oxygen therpy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
acute respiratory events
Time Frame: 28days
|
patients %
|
28days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
acute respiratory failure
Time Frame: 28 days
|
patients %
|
28 days
|
intubation rate
Time Frame: 28 days
|
patients %
|
28 days
|
ICU mortality
Time Frame: 28 days
|
patients %
|
28 days
|
ICU length of stay
Time Frame: 28 days
|
days
|
28 days
|
infectious and non infectious complications
Time Frame: 28 days
|
patients %
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
March 30, 2020
Study Completion (Actual)
November 15, 2020
Study Registration Dates
First Submitted
April 29, 2021
First Submitted That Met QC Criteria
May 3, 2021
First Posted (Actual)
May 7, 2021
Study Record Updates
Last Update Posted (Actual)
May 7, 2021
Last Update Submitted That Met QC Criteria
May 3, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIV _COPD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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