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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-07-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Incentive Spirometry on Post-operative Pulmonary Complications After Bariatric Surgery

NCT06756555

Bariatric Surgery Candidate

ACTIVE_NOT_RECRUITING

Optimizing PEEP in Laparoscopic Bariatric Surgery Using Bedside Lung Ultrasound

NCT04269564

Atelectasis, Postoperative Pulmonary

COMPLETED NA

Postoperative Hypoxemia in Obese Patients

NCT06589011

Atelectasis, Postoperative Pulmonary Bariatric Surgery

COMPLETED NA

Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Bariatric Surgery

NCT03026530

Pain, Postoperative Postoperative Nausea and Vomiting

COMPLETED NA

The Effect of Postoperative Incentive Spirometry on Pulmonary Function and Pulmonary Complications in Bariatric Surgery

NCT02431455

Obesity, Morbid Complications of Bariatric Procedures Pulmonary Atelectasis +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hospital Stay

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pursed Lip Breathing

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

Group Type EXPERIMENTAL

Pursed Lip Breathing

Intervention Type 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.

Incentive Spirometer

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.

Group Type ACTIVE_COMPARATOR

Incentive Spirometer

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes