- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04446520
Autogenic Drainage Effect on Blood Gases and Prevention of Pulmonary Complication After Upper Abdominal Surgery
November 23, 2020 updated by: Mona Mohamed Taha, Cairo University
Purpose: This study will find out the effect of Autogenic drainage on the prevention of pulmonary complications after upper abdominal surgery.
Method: Sixty patients post upper abdominal surgeries will be included, their ages ranged from 50 to 60 years old.
The patients will be divided into two groups, study group (A) include patients that receive first traditional physiotherapy (localized breathing exercise, diaphragmatic breathing, and splinted coughing) then autogenic drainage (B)-Group B: patients that receive traditional physiotherapy (localized breathing exercise, diaphragmatic breathing and splinted coughing)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Purpose: This study will find out the effect of Autogenic drainage on the prevention of pulmonary complications after upper abdominal surgery.
Method: Sixty patients post upper abdominal surgeries will be included, their ages ranged from 50 to 60 years old.
The patients will be divided into two groups, study group (A) include patients that receive first traditional physiotherapy (localized breathing exercise, diaphragmatic breathing, and splinted coughing) then autogenic drainage (B)-Group B: patients that receive traditional physiotherapy (deep breathing exercise, diaphragmatic breathing and splinted coughing)
Study Type
Interventional
Enrollment (Actual)
60
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
-
-
-
Cairo, Egypt, 11711
- Kasr Alaini
-
-
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
50 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age from 50 to 60 years
- Patients undergoing elective upper abdominal surgery with an abdominal incision longer than 5 cm that is above or extending above the umbilicus.
- Non-smoker patients
Exclusion Criteria:
- Patients developing cancer
- Patients with rib fractures
- Inability to comprehend and follow instructions.
- Pre-existing obstructive sleep apnea
- Current hospital patient for a separate episode of care.
- Patients requiring esophageal surgery or organ transplant.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: autogenic drainage and traditional physiotherapy
autogenic drainage technique plus traditional physiotherapy (localized breathing exercise, diaphragmatic breathing and splinted coughing)
|
breathing control using expiratory airflow to mobilize secretions from smaller to larger airways.
Secretions are cleared independently by adjusting the depth and speed of respiration in a sequence of controlled breathing techniques during exhalation in addition to traditional physiotherapy (deep breathing exercise, diaphragmatic breathing and splinted coughing)
|
Active Comparator: traditional physiotherapy
traditional physiotherapy (localized breathing exercise, diaphragmatic breathing, and splinted coughing)
|
breathing control using expiratory airflow to mobilize secretions from smaller to larger airways.
Secretions are cleared independently by adjusting the depth and speed of respiration in a sequence of controlled breathing techniques during exhalation in addition to traditional physiotherapy (deep breathing exercise, diaphragmatic breathing and splinted coughing)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
arterial blood gases
Time Frame: 7 days
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
prevalence of post operative pulmonary complication (pneumonia, hypoxemia and atelectasis) and number of days staying in ICU
Time Frame: 7 days
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mona Taha, PhD, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
June 27, 2020
Primary Completion (Actual)
August 28, 2020
Study Completion (Actual)
September 5, 2020
Study Registration Dates
First Submitted
June 21, 2020
First Submitted That Met QC Criteria
June 23, 2020
First Posted (Actual)
June 25, 2020
Study Record Updates
Last Update Posted (Actual)
November 24, 2020
Last Update Submitted That Met QC Criteria
November 23, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T REC/012/001740
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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