The purpose of this study is to compare incentive spirometry and peak expiratory flow meters to evaluate the cardiorespiratory parameter following valvular surgery and determine which has a better impact on cardiopulmonary problems after valvular surgery experience
Design
A concealed, randomized, single blinded study with two group/parallel design of 60 patients enrolled. And then allocated their respective groups. The treatment duration will be about 3 weeks.
Settings and conduct
Data will be collected from ICU of Ch. Pervaiz Elahi Institute of Cardiology Hospital, Multan
Participants/Inclusion and exclusion criteria
Inclusion criteria
Both male and female
Patients with age ranges of (35-65)
Patients who had recently undergone extubated heart valve surgery and who will be able to comply with the instructions and sign the consent form.
Patients who undergone median sternotomy-based valvular surgery.
Patients with stable hemodynamics
Exclusion criteria
Patients who needed to be intubated for more than 48 hours following surgery.
Re-intubation throughout the healing process.
Patients who within the previous three months had a history of a respiratory infection.
Patients undergo CABAG surgery.
Patients with any neuromuscular disease, renal disease, smokers, alcohol, anemia, and pregnant females.
Intervention groups
The total patient population will be split into two groups, one of which will use a peak expiratory flow meter and the other incentive spirometry
Muhammad Institute of Medical and Allied Sciences, Multan
Country
Pakistan
Phone
+92 301 6968008
Email address
kashafbhutta1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-24, 1402/01/04
Expected recruitment end date
2023-04-28, 1402/02/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of incentive spirometry and peak expiratory flow meter to evaluate cardiorespiratory parameters after valvular surgery
Public title
Comparison of incentive spirometry and peak expiratory flow meter to evaluate cardiorespiratory parameters after valvular surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients of both sexes i-e male and female
Patients with age ranges of (35-65yrs.)
Patients who have recently undergone extubated heart valve surgery and who will be able to comply with the instructions and sign the consent form.
Patients who underwent median sternotomy-based valvular surgery.
Patients with stable hemodynamics
Exclusion criteria:
Patients who needed to be intubated for more than 48 hours following surgery.
Re-intubation throughout the healing process
Patients who within the previous three months had a history of a respiratory infection
Patients undergo CABG surgery.
Patients with any neuromuscular disease, renal disease, smokers, alcohol, anemia, and pregnant females.
Age
From 35 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
Investigator
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization is simple. Total participants will be divided into two groups by lottery method. Each member of the population will be assigned by a number, after which members will be selected at random into groups. allocation concealment will also carried out.
Blinding (investigator's opinion)
Single blinded
Blinding description
The allocation will be known to the patients, the doctor, and the data analyst. However, the interventionist's therapist will be kept unaware. The trial follows established protocols to keep the staff members who delivered the interventions apart from those who took part in other aspects of the trial. the interventional personnel will be maintained masked to outcomes measurements and trial data and to minimize the biasness.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Muhammad Institute of Medical and Allied Sciences Multan
Before interventions and after 3 weeks of interventions
Method of measurement
Cardiorespiratory parameters like blood pressure will be measured by Arterial line.
2
Description
Heart rate
Timepoint
Before interventions and after 3 weeks of interventions
Method of measurement
Cardiorespiratory parameters like heart rate will be measured by arterial line.
3
Description
Respiratory rate
Timepoint
Before interventions and after 3 weeks of interventions
Method of measurement
Cardiorespiratory parameters like respiratory rate will be measured by arterial line.
4
Description
ABG's ( Atrial blood gasses)
Timepoint
Before interventions and after 3 weeks of interventions
Method of measurement
Cardiorespiratory parameters like ABG's (atrial blood gasses) will be measured by arterial line.
5
Description
Oxygen saturation
Timepoint
Before interventions and after 3 weeks of interventions.
Method of measurement
Oxygen saturation will be measured by probe of pulse oximeter.
Secondary outcomes
1
Description
Rating of perceived exertion
Timepoint
Before intervention and 3 weeks after intervention
Method of measurement
Rate of perceived exertion will be measured by Borg scale
2
Description
SF8 quality of life (A questionnaire)
Timepoint
Before intervention and 3 weeks after intervention
Method of measurement
patients will fill the SF8 quality of life questionnaire
Intervention groups
1
Description
Intervention group 1: Incentive spirometry 1.The patient will be asked to lie flat on a bed or a chair. The patient will be asked to grasp a pillow to help corset or brace the incision to lessen the pain on chest. 2.The patients will also be instructed to place the mouthpiece in their mouth and seal their lips tightly around it before slowly and fully exhaling.3.The next step is to inhale via their mouth slowly and deeply. The ball will rise when the breath will be taken.4.Patient will be asked to try to get the ball as high as possible.5.The patient will be instructed to hold their breath for at least 10 seconds after receiving it.6.After that, he or she will slowly exhale through their mouth. Next, they will be asked to take a 30 to 60 second break.7 It will be repeated 10 times for 3 sets for 3 weeks.
Category
Rehabilitation
2
Description
Intervention group 2: Peak expiratory flow meter 1.Patient will be asked to stand or sit up straight. 2.It will be made sure the red marker is located at the meter’s base. 3.The patient will inhale deeply until their lungs are filled .4.The participant will put the mouthpiece in his/her mouth and then press their lips firmly against the mouthpiece of the peak flow meter. 5.Then he/she will expel all the air as quickly and forcefully as they can. 6.On the meter, the number next to the red marker will be noted. 7. Pressure will be continually turned up.8. Maximal expiratory pressure would be found at that point, and this is where training of patient will be started. The knob will be turned back to one, and then it will be fully turned to the left. 9.While training, patient will be asked to rest for a minimum of 15 to 20 seconds.10.One set is made up of 3 repetitions of this exercise. 11. 15 training breaths across 3 breath sets will be completed.12. Intervention will be done in 3 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
ICU of Ch. Pervaiz Elahi Institute of Cardiology hospital, Multan.
Full name of responsible person
Dr. Atiq-ul-Mannan
Street address
Peera ghaeeb road Chock kumhara wala Multan
City
Multan
Postal code
66000
Phone
+92 334 6036848
Email
atiqulmannan23@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ch. Pervaiz Elahi Institute of Cardiology Hospital, Multan
Full name of responsible person
Dr. Atiq-ul-Mannan
Street address
Tariq road Multan
City
Multan
Postal code
66000
Phone
+92 334 6036848
Email
atiqulmannan23@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ch. Pervaiz Elahi Institute of Cardiology Hospital, Multan
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Muhammad Institute of medical and Allied sciences Multan
Full name of responsible person
Dr. Farah Zahid
Position
lecturer
Latest degree
Subspecialist
Other areas of specialty/work
Cardiopulmonary Physical Therapy
Street address
Peera Ghaeeb road chock khumhara wala Multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 306 1708076
Email
farahzahid977@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ch. Pervaiz Elahi Institute of Cardiology Hospital, Multan
Full name of responsible person
Dr. Atiq-ul-Mannan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
FCPS Pulmonology
Street address
Tariq road Multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 334 6036848
Email
atiqulmannan23@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Muhammad Institute of medical and allied sciences Multan
Full name of responsible person
Kashaf Khan Anjum Bhutta
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physical Therapy
Street address
house no. 86A/177, street no. 11 Mohalla Ameerabad Khechari Road Multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 301 6968008
Email
kashafbhutta1@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of individual personal information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Primary outcomes measures data will be shared
When the data will become available and for how long
after 6 months
To whom data/document is available
General population
Under which criteria data/document could be used
For Rehabilitation purposes
From where data/document is obtainable
From Google Scholar
What processes are involved for a request to access data/document