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

NCT06460584 | Recruiting

• 1 other identifier: REC/RCR&AHS/23/0368
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hospital Stay

Keywords

Dyspnea,; Incentive Spirometer; Oxygen Saturation; Whipple procedure

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Pursed Lip Breathing

EXPERIMENTAL

For the use of PLB exercise, the intervention will be given every day till the patient discharged from hospital. Patient will perform 5 sets. In each set, 10 times will be included

Other: Pursed Lip Breathing

Incentive Spirometer

ACTIVE COMPARATOR

The intervention will be given every day till the patient discharged from hospital. Patient will perform 5 sets, in each set, 10 times will be included and hold for 3 seconds but not more than 5 seconds. Reading will be taken on every 4rth POD and comparison will be done with 1st POD reading and so on.

Other: Incentive Spirometer

Interventions

Pursed Lip Breathing OTHER

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.

Pursed Lip Breathing

Incentive Spirometer OTHER

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.

Incentive Spirometer

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Sheikh Zayed Hospital,

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related 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.

  PMID: 29438817 BACKGROUND

• 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.

  PMID: 32843511 BACKGROUND

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sidra Afzal, PP-DPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IQBAL TARIQ, PHD

CONTACT

03338236752; iqbal.tariq@riphah.edu.pk

IMRAN AMJAD, PHD

CONTACT

03324390125; Imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: January 15, 2024
• Primary Completion: June 15, 2024
• Study Completion: July 15, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)