Clinical trial NCT06460584: Effect of Incentive Spirometer and Pursed Lip Breathing After Whipple Procedure.
Official title: Effect of Incentive Spirometer and Pursed Lip Breathing to Improve Dyspnea, Oxygen Saturation and Hospital Stay After Whipple Procedure.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hospital Stay
Keywords: Dyspnea,
Incentive Spirometer
Oxygen Saturation
Whipple procedure
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Whipple procedure is one of the most complex surgeries among hepatobiliary surgeries. It has named as Pancreaticoduodenectomy. It can cause many PPCs. Lung volumes are reduced due to atelectasis and pneumonia. Incentive spirometer (IS) is used to prevent PPCs. Due to general anesthesia, atelectasis is among most frequent PPCs. Pursed Lip Breathing (PLB) supports the patient to control the breath. The shriveling lips provide resistance to the air flowing out of the lungs. Airway collapse can be prevented by prolonged exhalation. Dyspnea occurs during 6MWT when patient performs walk in corridor. The aim of this study is to check the effect of Incentive Spirometer and Pursed Lip Breathing to improve dyspnea, oxygen saturation and hospital stay after Whipple procedure. This research of RCT will check the effect of IS and PLB by taking sample size of 60 post-operative patients through convenient sampling technique by allocating them randomly in group A and group B. Group A will receive PLB and group B will receive IS with baseline treatment chest percussions up to the duration of every day till discharge (reading will be collected on every 4rth day), dyspnea will be assessed through 6MWT and measured by Modified MRC dyspnea scale. The data will be analyzed through SPSS 26.


Eligibility criteria: Inclusion Criteria:

* Age (45 to 70)
* Type of Abdominal Surgery (Whipple Procedure) (11)
* Gender (Male and Female)
* Patients who has no history of pulmonary disease
* Smokers and nonsmokers

Exclusion Criteria:

* COPD (COPD patient with postoperative whipple procedure)
* Heart patient (patients who had history of heart disease along with whipple procedure)
* Uncontrolled Hypertension (patients who has have history of uncontrolled hypertension in postoperative whipple procedure)

Primary outcomes:
measure: Pulse Oximeter
timeFrame: baseline and fourth week
measure: Modified MRC Dyspnea Scale
timeFrame: baseline and fourth week
measure: 6-MWT
timeFrame: baseline and fourth week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Sheikh Zayed Hospital,
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sidra Afzal, PP-DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karim SAM, Abdulla KS, Abdulkarim QH, Rahim FH. The outcomes and complications of pancreaticoduodenectomy (Whipple procedure): Cross sectional study. Int J Surg. 2018 Apr;52:383-387. doi: 10.1016/j.ijsu.2018.01.041. Epub 2018 Feb 10.
citation: Kotta PA, Ali JM. Incentive Spirometry for Prevention of Postoperative Pulmonary Complications After Thoracic Surgery. Respir Care. 2021 Feb;66(2):327-333. doi: 10.4187/respcare.07972. Epub 2020 Aug 25.