Breathing Exercises for Pulmonary Function of Post-laparotomy Patients .

NCT ID: NCT04913428

Last Updated: 2021-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-30

Study Completion Date

2018-09-20

Brief Summary

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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

Detailed Description

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Pulmonary complications are common in post laparotomy patients because of multiple pre operative, intra operative and post operative factors. To manage these complications many interventions and breathing techniques are used. These complications alter the pulmonary function leading to decreased chest expansion, oxygen saturation and post operative atelectasis. Anesthetic drugs that also cause cardiac depression along with hemodynamic instability of the patient. Incision given to the chest or abdominal wall during procedure causes to lose the integrity of respiratory muscles which effects the functions of the muscle directly. Respiratory muscles are compromised, normal lung volumes are depressed. More than 75% of patients who are receiving neuromuscular blocking agent develops atelectasis. The estimated time after surgery for patient to return to its preoperative health status is approximately 6 weeks. These complications increase the hospital length of stay and cost associated with it as well as increase the morbidity and mortality.

Lung expansion techniques (LETs) are widely used to prevent postoperative pulmonary complications (PPCs). However, the effects of each of these techniques on thoraco-abdominal mechanics and PPC incidence after abdominal surgery remain unclear. Active Cycle of Breathing Techniques (ACBT) has shown to be effective in mobilizing and clearing the excess bronchial secretions and to improve lung function. It neither causes nor increases hypoxemia or increases airflow obstruction. Chest physiotherapy and breathing exercises are often prescribed to patients undergoing cardiac surgery and abdominal surgery in order to prevent or reduce post-operative pulmonary complications. There are different breathing techniques with and without mechanical devices after the surgery, but there is controversy regarding which breathing techniques are the most effective.

Researches have proved change in pulmonary functions by the use of various breathing exercises. Depressed pulmonary functions i.e. decreased forced vital capacity (FVC) , decreased forced expiratory volume (FEV1), Peak Expiratory Flow Rate (PEFR) are seen as result of disturbed lung function. Alteration in function of diaphragm contributes in postoperatively pulmonary function disturbances. Chest physiotherapy is implied for minimizing the altered lung functions and complications. This includes multiple breathing exercises, percussion , vibrations, huffing, coughing techniques, postural drainage and mobilization.

The current study is conducted to compare two respiratory techniques for the improvement in post operative pulmonary function; because of incisional pain, patients find the inspiratory exercises difficult to perform, therefore, the study is conducted to assess if easy-to -perform expiratory techniques are similar in effect to the inspiratory techniques and for the said purpose comparison of blow bottle technique and interdigital breathing on post laparotomy patients is made for the improvement of pulmonary function and vitals of these patients.

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Conditions

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Laparotomy Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Interdigital exercise group

Interdigital 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

Group Type EXPERIMENTAL

Interdigital exercise

Intervention Type OTHER

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.

Blow-Bottle technique group

Blow-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

Group Type ACTIVE_COMPARATOR

Blow-Bottle technique

Intervention Type OTHER

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.

Interventions

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Interdigital exercise

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.

Intervention Type OTHER

Blow-Bottle technique

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Post laparotomy patients
* Age 25 to 45 years.
* Both genders.

Exclusion Criteria

* Vitally unstable patients
* Complicated laparotomies
* Patients with post-operative complications e.g. delirium
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suman Sheraz, PhD*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Riphah International University

Rawalpindi, Federal, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 11978282 (View on PubMed)

Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.

Reference Type BACKGROUND
PMID: 28186222 (View on PubMed)

Dagan 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.

Reference Type BACKGROUND
PMID: 25125786 (View on PubMed)

Alaparthi 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.

Reference Type BACKGROUND
PMID: 27525116 (View on PubMed)

Craig DB. Postoperative recovery of pulmonary function. Anesth Analg. 1981 Jan;60(1):46-52. No abstract available.

Reference Type BACKGROUND
PMID: 7006464 (View on PubMed)

Agostini 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.

Reference Type BACKGROUND
PMID: 23429831 (View on PubMed)

Tyson 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.

Reference Type BACKGROUND
PMID: 25607594 (View on PubMed)

Lunardi 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.

Reference Type BACKGROUND
PMID: 25973670 (View on PubMed)

Westerdahl 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.

Reference Type BACKGROUND
PMID: 11474953 (View on PubMed)

Other Identifiers

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REC/00313 Huda Anjum

Identifier Type: -

Identifier Source: org_study_id

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