Autogenic Drainage Effect on Blood Gases and Prevention of Pulmonary Complication After Upper Abdominal Surgery
Primary Purpose
Postoperative Complications
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
autogenic drainage
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Complications focused on measuring Autogenic drainage, blood gases, Pneumonia,, upper abdominal surgery, Postoperative pulmonary Complications
Eligibility Criteria
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.
Sites / Locations
- Kasr Alaini
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
autogenic drainage and traditional physiotherapy
traditional physiotherapy
Arm Description
autogenic drainage technique plus traditional physiotherapy (localized breathing exercise, diaphragmatic breathing and splinted coughing)
traditional physiotherapy (localized breathing exercise, diaphragmatic breathing, and splinted coughing)
Outcomes
Primary Outcome Measures
arterial blood gases
Secondary Outcome Measures
prevalence of post operative pulmonary complication (pneumonia, hypoxemia and atelectasis) and number of days staying in ICU
Full Information
NCT ID
NCT04446520
First Posted
June 21, 2020
Last Updated
November 23, 2020
Sponsor
Cairo University
Collaborators
Princess Nourah Bint Abdulrahman University
1. Study Identification
Unique Protocol Identification Number
NCT04446520
Brief Title
Autogenic Drainage Effect on Blood Gases and Prevention of Pulmonary Complication After Upper Abdominal Surgery
Official Title
Autogenic Drainage Effect on Blood Gases and Prevention of Pulmonary Complication After Upper Abdominal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 27, 2020 (Actual)
Primary Completion Date
August 28, 2020 (Actual)
Study Completion Date
September 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Princess Nourah Bint Abdulrahman University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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)
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
Autogenic drainage, blood gases, Pneumonia,, upper abdominal surgery, Postoperative pulmonary Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
autogenic drainage and traditional physiotherapy
Arm Type
Experimental
Arm Description
autogenic drainage technique plus traditional physiotherapy (localized breathing exercise, diaphragmatic breathing and splinted coughing)
Arm Title
traditional physiotherapy
Arm Type
Active Comparator
Arm Description
traditional physiotherapy (localized breathing exercise, diaphragmatic breathing, and splinted coughing)
Intervention Type
Procedure
Intervention Name(s)
autogenic drainage
Intervention Description
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)
Primary Outcome Measure Information:
Title
arterial blood gases
Time Frame
7 days
Secondary Outcome Measure Information:
Title
prevalence of post operative pulmonary complication (pneumonia, hypoxemia and atelectasis) and number of days staying in ICU
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona Taha, PhD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alaini
City
Cairo
ZIP/Postal Code
11711
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34787294
Citation
Taha MM, Draz RS, Gamal MM, Ibrahim ZM. Adding autogenic drainage to chest physiotherapy after upper abdominal surgery: effect on blood gases and pulmonary complications prevention. Randomized controlled trial. Sao Paulo Med J. 2021 Nov 15;139(6):556-563. doi: 10.1590/1516-3180.2021.0048.0904221. eCollection 2021.
Results Reference
derived
Learn more about this trial
Autogenic Drainage Effect on Blood Gases and Prevention of Pulmonary Complication After Upper Abdominal Surgery
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