Clinical trial NCT06078644: Respiratory Exercise Diary in Major Abdominal Surgery
Official title: Effect of Respiratory Exercise Diary Use on Pulmonary Complications and Functional Capacity in Major Abdominal Surgery: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Complication
Keywords: general surgery
breathing exercises
dyspnea
fatigue
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Postoperative pulmonary complications are common and lead to increased morbidity and mortality in patients. These complications are observed especially after major surgical interventions. Breathing exercises performed with or without the use of a device are extremely important in preventing postoperative pulmonary complications. Breathing exercises that increase total lung capacity by encouraging the use of the diaphragm reverse alveolar collapse and postoperative hypoxemia. This study aim to determine the effect of postoperative respiratory exercise diary use in patients undergoing major abdominal surgery on dyspnea, fatigue, respiratory parameters (respiratory rate, SPO2, cough, sputum), early pulmonary complications, spirometry use and functional capacity.The research is planned to be conducted in a single-blind, randomized controlled manner. In the study, 60 patients (30 intervention and 30 control) who underwent major abdominal surgery will be included.Data will be collected using the Patient Introduction Form, Visual Analogue Scale, Medical Research Board Scale, 2-minute walk test, breathing exercise diary and patient follow-up chart.Patients in the intervention and control groups will be visited by the researcher for 3 postoperative days, respiratory parameters, cough, and sputum status will be recorded in the patient follow-up chart, and the use of a respiratory exercise diary will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Undergoing elective surgery
* Receiving general anesthesia
* Having major abdominal surgery (colorectal surgery, gastrectomy, liver resection, pancreatectomy)
* Staying in the general surgery service for at least 3 days after the surgery
* Becoming literate

Exclusion Criteria:

* Psychoactive drug use
* Having Alzheimer's or dementia
* Having chronic respiratory diseases (COPD, asthma)

Primary outcomes:
measure: Spirometry use
timeFrame: 1-3 days
Secondary outcomes:
measure: dyspnea
timeFrame: 1-3 days
measure: fatigue
timeFrame: 1-3 days
measure: Pulmonary functional capacity
timeFrame: 1-3 days
measure: Respiratory rate
timeFrame: 1-3 days
measure: Oxygen saturation
timeFrame: 1-3 days
measure: Cough
timeFrame: 1-3 days
measure: Mucus
timeFrame: 1-3 days
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
Study officials:
References:
citation: Toor H, Kashyap S, Yau A, Simoni M, Farr S, Savla P, Kounang R, Miulli DE. Efficacy of Incentive Spirometer in Increasing Maximum Inspiratory Volume in an Out-Patient Setting. Cureus. 2021 Oct 4;13(10):e18483. doi: 10.7759/cureus.18483. eCollection 2021 Oct.
citation: Unver S, Kivanc G, Alptekin HM. Deep breathing exercise education receiving and performing status of patients undergoing abdominal surgery. Int J Health Sci (Qassim). 2018 Jul-Aug;12(4):35-38.
citation: Westerdahl E, Lindmark B, Eriksson T, Hedenstierna G, Tenling A. The immediate effects of deep breathing exercises on atelectasis and oxygenation after cardiac surgery. Scand Cardiovasc J. 2003 Dec;37(6):363-7. doi: 10.1080/14017430310014984.
citation: McTier L, Botti M, Duke M. Patient participation in pulmonary interventions to reduce postoperative pulmonary complications following cardiac surgery. Aust Crit Care. 2016 Feb;29(1):35-40. doi: 10.1016/j.aucc.2015.04.001. Epub 2015 May 1.