Hospital StayNCT06460584
Effect of Incentive Spirometer and Pursed Lip Breathing After Whipple Procedure.
A study testing Pursed Lip Breathing and Incentive Spirometer in people with Hospital Stay, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hospital Stay
- What is being tested?
- Pursed Lip Breathing and Incentive Spirometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2024to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Sheikh Zayed Hospital,
Lahore, Punjab Province, 54000
Sidra Afzal, PP-DPT, 03124378540, sidra.afzal@riphah.edu.pk
About this study
Official title: Effect of Incentive Spirometer and Pursed Lip Breathing to Improve Dyspnea, Oxygen Saturation and Hospital Stay After Whipple Procedure.
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
- Being tested
- Pursed Lip Breathing, Incentive Spirometer
- Keywords
- Dyspnea,, Incentive Spirometer, Oxygen Saturation, Whipple procedure
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pursed Lip BreathingOther
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 SpirometerOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Incentive Spirometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: baseline and fourth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start15 Jan 2024
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hospital StayStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Afzal, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460584
- Sponsor's protocol ID
- REC/RCR&AHS/23/0368
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29438817Kotta 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.
PubMed 32843511
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Incentive Spirometer and Pursed Lip Breathing to Improve Dyspnea, Oxygen Saturation and Hospital Stay After Whipple Procedure.
- ClinicalTrials.gov ID
- NCT06460584
- Acronym / sponsor ID
- REC/RCR&AHS/23/0368
- Conditions
- Hospital Stay
- Keywords
- Dyspnea,, Incentive Spirometer, Oxygen Saturation, Whipple procedure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pursed Lip Breathing | Experimental | Other: Pursed Lip BreathingFor 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 |
| Incentive Spirometer | Active comparator | Other: Incentive SpirometerThe 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. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pursed Lip BreathingIn 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. | Other | Pursed Lip Breathing |
| Incentive SpirometerFor 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. | Other | Incentive Spirometer |
Primary outcome
Pulse Oximeter
Time frame: baseline and fourth week
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
Modified MRC Dyspnea Scale
Time frame: baseline and fourth week
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
6-MWT
Time frame: baseline and fourth week
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 29438817Karim 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.
- Background: PubMed 32843511Kotta 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sidra Afzal, PP-DPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pursed Lip Breathing and Incentive Spirometer in people with Hospital Stay, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact IQBAL TARIQ, PHD (03338236752, iqbal.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Oximeter (time frame: baseline and fourth week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06460584, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.