Effect of Incentive Spirometer and Pursed Lip Breathing After Whipple Procedure.

Hospital Stay Clinical Trial

Official title:

Effect of Incentive Spirometer and Pursed Lip Breathing to Improve Dyspnea, Oxygen Saturation and Hospital Stay After Whipple Procedure.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06460584
• Other study ID #: REC/RCR&AHS/23/0368
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: July 15, 2024

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: IQBAL TARIQ, PHD
• Phone: 03338236752
• Email: iqbal.tariq[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hospital Stay

Intervention

Other:
• Pursed Lip Breathing
In each set, 10 times will be included. Reading will be taken from 1st POD and comparison will be done on each 4rth POD. Ask the patient to sit in a comfortable position and relax. Then, instruct the patient to take deep breath 12 through nose for two counts, and keep mouth closed. Inhale for 2 seconds. Now, ask the patient to purse the lips as if the patient was going to gently flicker the flame of candle. Now the patient will breathe out gently while counting for 4 seconds.
• Incentive Spirometer
For the use of flow based IS, the Patient will be sited in a comfortable Position (Semi-Recumbent Position Of 45 Degrees), With a Pillow under the knees or Semi-Fowler Position on bed, and then asked to perform this technique with the same order to ensure that she / he understands the process. The patient will be instructed to inhale with a slow continuous and deep breathing, and hold for a period of not less than 5 seconds and exhale passively. And is instructed to hold the spirometry upright to perform slowly inhalation, thus lifting the ball. At the end of the evaluation of respiratory measures for patients with lung function, and then compare the results with the previous results. IS will be recommended to be performed by patient every 10 breaths hourly and 5 times per day.

Locations

Country	Name	City	State
Pakistan	Sheikh Zayed Hospital,	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse Oximeter	Pulse oximetry is a simple and non-invasive method used to examine oxygen saturation (SpO2) in various parts of body. Convenient use, speed and high accuracy in detection of hypoxia and continuous monitoring of patients are other features of pulse oximetry	baseline and fourth week
Primary	Modified MRC Dyspnea Scale	Medical Research Council (MRC) dyspnea scale the first clinical scale for the determination of dyspnea, is a 5-point scale based on the sensation of breathing difficulty experienced by the patient during daily life activities Patients, reading the 10 scale, are invited to recognize their own level of respiratory fatigue or, as is more often the case, the MRC can be directly administered	baseline and fourth week
Primary	6-MWT	For the performance ability in many cardiopulmonary diseases, the most commonly used assessment tool is six minute walk test (6MWT). It has been widely used in research to evaluate the exercise capacity of various patient population (15). The test is standardized and reproducible self-paced exercise test. Patient is being asked to walk in a long hallway corridor for 6 minute between two cones on a flat surface. Ask the patient to keep walking. If the patient feels dyspnea, he or she may sit for a while. In healthy subjects with no history of pulmonary disease, the 6-min walk distance ranges from 400 to 700 m	baseline and fourth week