Breathing Exercises for Pulmonary Function of Post-laparotomy Patients .
Comparison of Blow-bottle Technique and Interdigital Breathing for Pulmonary Function of Post-laparotomy Patients .
1 other identifier
interventional
28
1 country
1
Brief Summary
The study is designed to compare the effects of blow bottle technique and interdigital exercises on the pulmonary functions of the post laparotomy patients where there is sudden decline in lung function and increased rate of complications after the surgery. A randomized control trial was conducted including post laparotomy patients, randomly allocated to interventional and control groups. Both the groups received breathing exercises along with conventional treatment during phase I rehabilitation. Data was collected at baseline, before and after every session and after 6 sessions before patient discharge from hospital. Outcome measures include assessment of lung volumes and capacities, oxygen saturation and vitals of the post laparotomy patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2018
CompletedFirst Submitted
Initial submission to the registry
May 30, 2021
CompletedFirst Posted
Study publicly available on registry
June 4, 2021
CompletedJune 4, 2021
May 1, 2021
6 months
May 30, 2021
May 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Peak expiratory flow rate (PEFR)
Peak expiratory flow rate (PEFR) measured through digital spirometer. Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings.
5 days
Forced vital capacity (FVC)
Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal.
5 days
Forced expiratory volume in 1sec (FEV1)
Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal.
5 days
FVC/FEV1
FVC/FEV1 measured through digital spirometer. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65).
5 days
Secondary Outcomes (4)
Oxygen Saturation (SPO2)
5 days
Heart rate
5 days
Chest expansion
5 days
Respiratory rate
5 days
Study Arms (2)
Interdigital exercise group
EXPERIMENTALInterdigital exercises: 12 repetitions in 3 sets of 4 repetitions Conventional Physical Therapy: Incentive spirometer 3 - 4 times a day, Percussion twice a day, Mobilization of the patient Total session given was for 20 -30 minutes
Blow-Bottle technique group
ACTIVE COMPARATORBlow-Bottle technique: 12 repetitions in 3 sets of 4 repetitions Conventional Physical Therapy: Incentive spirometer 3 - 4 times a day, Percussion twice a day, Mobilization of the patient Total session given was for 20 -30 minutes
Interventions
Patient asked to sit in upright position interlocking their fingers with inhaling deeply bringing the arms up and exhaling through mouth while bring the arm down.
For blow bottle 20cm of bottle filled with 10cm of water in which a tube of length 35- 40cm inserted with the inner diameter of ≥8mm(21).Patient is asked to form bubbles in bottle by exhaling in bottle performing Forced Expiratory Techniques.
Eligibility Criteria
You may qualify if:
- Post laparotomy patients
- Age 25 to 45 years.
- Both genders.
You may not qualify if:
- Vitally unstable patients
- Complicated laparotomies
- Patients with post-operative complications e.g. delirium
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Riphah International University
Rawalpindi, Federal, 44000, Pakistan
Related Publications (9)
Giacalone PL, Daures JP, Vignal J, Herisson C, Hedon B, Laffargue F. Pfannenstiel versus Maylard incision for cesarean delivery: A randomized controlled trial. Obstet Gynecol. 2002 May;99(5 Pt 1):745-50. doi: 10.1016/s0029-7844(02)01957-9.
PMID: 11978282BACKGROUNDMiskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.
PMID: 28186222BACKGROUNDDagan Y, Wiser I, Weissman O, Farber N, Hundeshagen G, Winkler E, Kazula-Halabi T, Haik J. An Improvised "Blow Glove" Device Produces Similar PEP Values to a Commercial PEP Device: An Experimental Study. Physiother Can. 2014 Summer;66(3):308-12. doi: 10.3138/ptc.2013-31.
PMID: 25125786BACKGROUNDAlaparthi GK, Augustine AJ, Anand R, Mahale A. Comparison of Diaphragmatic Breathing Exercise, Volume and Flow Incentive Spirometry, on Diaphragm Excursion and Pulmonary Function in Patients Undergoing Laparoscopic Surgery: A Randomized Controlled Trial. Minim Invasive Surg. 2016;2016:1967532. doi: 10.1155/2016/1967532. Epub 2016 Jul 21.
PMID: 27525116BACKGROUNDCraig DB. Postoperative recovery of pulmonary function. Anesth Analg. 1981 Jan;60(1):46-52. No abstract available.
PMID: 7006464BACKGROUNDAgostini P, Naidu B, Cieslik H, Steyn R, Rajesh PB, Bishay E, Kalkat MS, Singh S. Effectiveness of incentive spirometry in patients following thoracotomy and lung resection including those at high risk for developing pulmonary complications. Thorax. 2013 Jun;68(6):580-5. doi: 10.1136/thoraxjnl-2012-202785. Epub 2013 Feb 21.
PMID: 23429831BACKGROUNDTyson AF, Kendig CE, Mabedi C, Cairns BA, Charles AG. The effect of incentive spirometry on postoperative pulmonary function following laparotomy: a randomized clinical trial. JAMA Surg. 2015 Mar 1;150(3):229-36. doi: 10.1001/jamasurg.2014.1846.
PMID: 25607594BACKGROUNDLunardi AC, Paisani DM, Silva CCBMD, Cano DP, Tanaka C, Carvalho CRF. Comparison of lung expansion techniques on thoracoabdominal mechanics and incidence of pulmonary complications after upper abdominal surgery: a randomized and controlled trial. Chest. 2015 Oct;148(4):1003-1010. doi: 10.1378/chest.14-2696.
PMID: 25973670BACKGROUNDWesterdahl E, Lindmark B, Almgren SO, Tenling A. Chest physiotherapy after coronary artery bypass graft surgery--a comparison of three different deep breathing techniques. J Rehabil Med. 2001 Mar;33(2):79-84. doi: 10.1080/165019701750098920.
PMID: 11474953BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Suman Sheraz, PhD*
Riphah International University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2021
First Posted
June 4, 2021
Study Start
March 30, 2018
Primary Completion
September 20, 2018
Study Completion
September 20, 2018
Last Updated
June 4, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share