Abdominal SurgeryNCT06454305
Effects of ACBT and Blow Bottle Technique in Patients With Abdominal Surgeries Under General Anesthesia
A study testing Active cycle of breathing technique and Blow Bottle Technique in people with Abdominal Surgery, run by Riphah International University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Abdominal Surgery
- What is being tested?
- Active cycle of breathing technique and Blow Bottle Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2024to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Elective surgeries under spinal anesthesia Emergency surgeries Cardiothoracic surgeries Neurological impairment, prolong surgeries Psychological impairment Head and neck surgeries and vascular surgeries Hemodynamically unstable
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Cairns Railway Hospital Lahore
Lahore, Punjab Province, 54000
Sidra Afzal, PP-DPT, 03124378540, sidra.afzal@riphah.edu.pk
About this study
Official title: 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.
- Conditions
- Abdominal Surgery
- Being tested
- Active cycle of breathing technique, Blow Bottle Technique
- Keywords
- Abdominal Surgeries, Active cycle of breathing Technique, Blow Bottle Technique, Pulmonary Complications,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active cycle of breathing techniqueOther
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
Blow Bottle TechniqueOther
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
| Study group | Role | What they receive |
|---|---|---|
| Active cycle of breathing technique | Experimental | 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 Receives: Other: Active cycle of breathing technique |
| Blow Bottle Technique | Active comparator | 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 Receives: Other: Blow Bottle Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Oximeter
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
Measured: baseline and fourth week
Spirometer
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
Measured: baseline and fourth week
Breathlessness, Cough and Sputum Scale (BCSS)
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
Measured: baseline and fourth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start15 Jan 2024
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Afzal, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454305
- Sponsor's protocol ID
- REC/RCR&AHS/23/0380
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31141541Kokotovic 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.
PubMed 33026459Boden 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.
PubMed 32680742
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06454305
- Acronym / sponsor ID
- REC/RCR&AHS/23/0380
- Conditions
- Abdominal Surgery
- Keywords
- Abdominal Surgeries, Active cycle of breathing Technique, Blow Bottle Technique, Pulmonary Complications,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active cycle of breathing technique | Experimental | Other: Active cycle of breathing techniqueBreathing 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 |
| Blow Bottle Technique | Active comparator | Other: Blow Bottle Technique1-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 |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Elective surgeries under spinal anesthesia Emergency surgeries Cardiothoracic surgeries Neurological impairment, prolong surgeries Psychological impairment Head and neck surgeries and vascular surgeries Hemodynamically unstable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active cycle of breathing techniqueBreathing 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 | Other | Active cycle of breathing technique |
| Blow Bottle TechniqueA 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 | Other | Blow Bottle Technique |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Background: PubMed 31141541Cui 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.
- Background: PubMed 33026459Kokotovic 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.
- Background: PubMed 32680742Boden 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.
- Individual participant dataSharing planned: No
Related trials for Abdominal Surgery
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruiting
Nurse-Led Prehabilitation Before Major Abdominal Cancer Surgery
Colorectal Cancer
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Recruiting
Vagal Stimulator to Reduce Nasogastric Tube Use
Nasogastric Tube Intubation
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sidra Afzal, PP-DPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active cycle of breathing technique and Blow Bottle Technique in people with Abdominal Surgery, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact IQBAL TARIQ, PHD (03338236752, iqbal.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Oximeter (time frame: baseline and fourth week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06454305, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.