- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06454305
Effects of ACBT and Blow Bottle Technique in Patients With Abdominal Surgeries Under General Anesthesia
Comparative Effects of Active Cycle of Breathing Technique and Blow Bottle Technique to Prevent Post-operative Pulmonary Complications in Patients With Abdominal Surgeries Under General Anesthesia
A postoperative pulmonary complication (PPC) is the most common serious complication after Abdominal surgery under GA which lead to longer hospital stays and have deleterious outcomes on lung volumes, mucociliary clearance, accumulation of mucus, saliva and cough reflex. Chest physiotherapy for airway clearance which includes postural drainage, chest percussion, vibrations, Along with these, breathing exercises such ACBT and Blow bottle technique are recommended to clear secretion which aid in enhancing pulmonary function by effectively mobilizing and eliminating excess bronchial secretions.
This study of randomized clinical trial will check the comparative effect of ACBT and Blow Bottle Technique in patients with abdominal surgeries under GA by taking a sample of 44 patients through non probability convenience sampling technique. Subject of both gender will be included between the age of 30 to 50 years who will undergoes with elective abdominal surgeries under GA (Cholecystectomy, Hysterectomy ,Appendectomy, Hemorrhoidectomy) and Laparoscopic /open. Elective surgeries under spinal anesthesia, emergency surgeries, cardiothoracic surgeries and hemodynamically unstable subjects will be excluded. 22 subjects will receive ACBT and other 22 subjects will receive Blow bottle technique for 20 minutes duration per session, two sessions per day for a period of 5 days. The status of airway clearance, oxygen saturation and lungs volumes will be measured pre and post intervention on day 1 and at the end of 5th day by using BCSS, Pulse oximeter and Spirometer.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: Imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: iqbal Tariq, phd
- Phone Number: 03338236752
- Email: iqbal.tariq@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Recruiting
- Cairns Railway Hospital Lahore
-
Contact:
- Sidra Afzal, PP-DPT
- Phone Number: 03124378540
- Email: sidra.afzal@riphah.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 30 to 50 Gender: male/Female Both Elective surgeries Under General Anesthesia (Cholecystectomy, Hysterectomy ,Appendectomy, Hemorrhoidectomy) Laparoscopic /open both POCs: Sputum retention, hypoxemia, impair pulmonary function From the day 0 or immediate after surgery
Exclusion Criteria:
- Elective surgeries under spinal anesthesia Emergency surgeries Cardiothoracic surgeries Neurological impairment, prolong surgeries Psychological impairment Head and neck surgeries and vascular surgeries Hemodynamically unstable
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active cycle of breathing technique
Breathing control, thoracic expansion and forced expiratory training are the three components of ACBT.
The purpose of the thoracic expansion phase is to facilitate the release of secretions, enhance ventilation, and supply the necessary volume for forced expiratory breathing
|
Breathing control, thoracic expansion and forced expiratory training are the three components of ACBT.
The purpose of the thoracic expansion phase is to facilitate the release of secretions, enhance ventilation, and supply the necessary volume for forced expiratory breathing.
Secretions are moved into the central airways during the forceful expiratory exercise that follows The three stages of ACBT
|
|
Active Comparator: Blow Bottle Technique
1-liter plastic bottle was filled with water to a height of 10 centimeters for this intervention.
The water in the bottle was filled using a 30-cm-long tube that was placed 8 cm down.
The participants were instructed to sit on a bed with comfortable position, Hold the bottle with one hand and the tube with the other Blowing Technique, Put the tube in mouth by holding lips firmly,Breathing in through nose and out through mouth,Blowing enough water is bubbled,Short Breaks for 2 to 3 mints, When mucus rises up get out of by cough and huff
|
A 1-liter plastic bottle was filled with water to a height of 10 centimeters for this intervention.
The water in the bottle was filled using a 30-cm-long tube that was placed 8 cm down.
The participants were instructed to sit on a bed with comfortable position, Hold the bottle with one hand and the tube with the other Blowing Technique, Put the tube in mouth by holding lips firmly, Breath in through nose and out through mouth, Blowing enough water is bubbled, Short Breaks for 2 to 3 mints, When mucus rises up get out of it by coughing or huffing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulse Oximeter
Time Frame: baseline and fourth week
|
An invasive technique for keeping an eye on someone's blood oxygen saturation is pulse oximetry.
The accuracy of peripheral oxygen saturation measurements is usually 2% of the arterial oxygen saturation level obtained from arterial blood gas analysis, which is a more precise measurement.
It may decrease and remain low owing to specific cardiovascular problems, or it may peak and climb after a run or other physical activity.
Nonetheless, conventional research indicates that the usual range for pulse rate on an oximeter in healthy persons is between 60 and 100 beats per minute
|
baseline and fourth week
|
|
Spirometer
Time Frame: baseline and fourth week
|
The most used pulmonary function test is spirometry.
It assesses the capacity of the lungs to breathe in and out, especially the volume and/or velocity of air that can be expelled.
When evaluating breathing patterns to detect diseases including asthma, pulmonary fibrosis, cystic fibrosis, and COPD, spirometry is useful.
An FEV1/FVC ratio larger than 0.70 with both FEV1 and FVC over 80% of the expected value are considered normal spirometry data.
TLC exceeding 80% of the predicted value is typical in the event that lung volumes are measured.
Diffusion capacity that is more than 75% of the expected value is likewise regarded as typical
|
baseline and fourth week
|
|
Breathlessness, Cough and Sputum Scale (BCSS)
Time Frame: baseline and fourth week
|
A three-item questionnaire used to evaluate the patient's cough, sputum, and dyspnea forms the basis of the BCSS.
Using a Likert scale, with 0 denoting improved symptoms and a 4 denoting deteriorating symptoms, individuals can register their symptoms on the BCSS.
Patients are asked to assess the severity of each of the three symptoms on a 5-point scale as part of the BCSS, a patient-reported outcome measure.
Higher scores denote more severe symptoms.
A total score is obtained by adding the item scores
|
baseline and fourth week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sidra Afzal, PP-DPT, Riphah International University
Publications and helpful links
General Publications
- Cui Y, Cao R, Li G, Gong T, Ou Y, Huang J. The effect of lung recruitment maneuvers on post-operative pulmonary complications for patients undergoing general anesthesia: A meta-analysis. PLoS One. 2019 May 29;14(5):e0217405. doi: 10.1371/journal.pone.0217405. eCollection 2019.
- Kokotovic D, Berkfors A, Gogenur I, Ekeloef S, Burcharth J. The effect of postoperative respiratory and mobilization interventions on postoperative complications following abdominal surgery: a systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2021 Aug;47(4):975-990. doi: 10.1007/s00068-020-01522-x. Epub 2020 Oct 7.
- Boden I, Robertson IK, Neil A, Reeve J, Palmer AJ, Skinner EH, Browning L, Anderson L, Hill C, Story D, Denehy L. Preoperative physiotherapy is cost-effective for preventing pulmonary complications after major abdominal surgery: a health economic analysis of a multicentre randomised trial. J Physiother. 2020 Jul;66(3):180-187. doi: 10.1016/j.jphys.2020.06.005. Epub 2020 Jul 14.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REC/RCR&AHS/23/0380
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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