NCT06454305

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 6, 2024

Last Update Submit

June 6, 2024

Conditions

Keywords

Abdominal SurgeriesActive cycle of breathing TechniqueBlow Bottle TechniquePulmonary Complications,

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    baseline and fourth week

Study Arms (2)

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

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

Other: Blow Bottle Technique

Interventions

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 cycle of breathing technique

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

Blow Bottle Technique

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Elective surgeries under spinal anesthesia Emergency surgeries Cardiothoracic surgeries Neurological impairment, prolong surgeries Psychological impairment Head and neck surgeries and vascular surgeries Hemodynamically unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairns Railway Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (3)

  • 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.

    PMID: 31141541BACKGROUND
  • 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.

    PMID: 33026459BACKGROUND
  • 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.

    PMID: 32680742BACKGROUND

Study Officials

  • Sidra Afzal, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2024

First Posted

June 12, 2024

Study Start

January 15, 2024

Primary Completion

July 15, 2024

Study Completion

July 15, 2024

Last Updated

June 12, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations