Protocol summary

Study aim
Determining the comparative effect of incentive spirometry and deep breathing exercise on hemodynamic indices and pulmonary complications during and after sleeve surgery in Imam Khomeini hospital, Tehran, in 2023
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, Study on 75 patients, block randomization was used for randomization.
Settings and conduct
Patients who refer to Imam Khomeini hospital in Tehran for sleeve surgery in 2023.
Participants/Inclusion and exclusion criteria
Admission: candidate for sleeve surgery, willing to cooperate, ASA1 and ASA2 anesthesia class one and two. with BMI above 35, age range 16 to 76 years old. Withdrawal: patients with severe chest or upper abdominal pain (VAS more than 75).
Intervention groups
The first group of the test will use incentive spirometry and the second group will use the deep breathing technique two hours before the operation and two, six and ten hours after the operation, after the procedure and during the surgery, venous blood gas samples , blood pressure, heart rate, arterial blood oxygen saturation and hemodynamics of the patients will be documented and to check the effectiveness the incidence of atelectasis and pneumonia (up to two weeks after the operation) and the length of stay of the patients in the hospital will be checked. In the control group, there will be no special intervention and they will only receive routine hospital cares.
Main outcome variables
Hemodynamic indicators include: oxygen saturation, blood pH, heart rate, systolic and diastolic blood pressure, blood CO2

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230223057511N1
Registration date: 2023-05-08, 1402/02/18
Registration timing: registered_while_recruiting

Last update: 2023-05-08, 1402/02/18
Update count: 0
Registration date
2023-05-08, 1402/02/18
Registrant information
Name
Fereshteh Farzanmehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2208 6052
Email address
fereshteh.farzanmehr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of incentive spirometry and deep breathing exercise on hemodynamic indicators and pulmonary complications during and after sleeve surgery.
Public title
Investigating the effect of incentive spirometry and deep breathing exercise on sleeve surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for sleeve surgery Willing to cooperate ASA level one or two Having a BMI above 35 Age range from 16 to 76 years
Exclusion criteria:
Patients with severe chest or upper abdominal pain (VAS more than 75).
Age
From 16 years old to 76 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
For this research, before the start of the study, after obtaining informed consent before the operation, the patients are referred continuously and available, and with the block randomization method, they are divided into three groups: incentive spirometry (I), deep breathing exercise (D), and control. (C) or routine will be assigned. The blocks of this study are 6 (II, DD, CC) which will create 27 states, first determine the possible states of these 6 letters inside the blocks and then randomly Simple and by using random numbers table number 17, the number of blocks that will complete the number of samples will be determined (1 - 27), in this way the type of intervention is determined based on the desired letters with the number of each patient and in a master sheet will be kept and the continuous entry number of the patients will be written on the envelope, and the type of intervention or control will be specified inside the envelope. Gradually, according to the presence of eligible patients, the relevant envelope is returned and the type of intervention inside the non-transparent envelope is determined and the desired technique is performed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Journal office, Research and Technology Deputy,Third Floor,Building No2, Mazandaran University of Medical Sciences and Healthcare Services, Moalem Square, Sari
City
Sari
Province
Mazandaran
Postal code
1295498972
Approval date
2023-04-08, 1402/01/19
Ethics committee reference number
IR.MAZUMS.REC.1402.024

Health conditions studied

1

Description of health condition studied
Sleeve surgery patients
ICD-10 code
E66.01
ICD-10 code description
Morbid (severe) obesity due to excess calories

Primary outcomes

1

Description
Blood oxygen saturation
Timepoint
Blood oxygen saturation is recorded two hours before surgery after using incentive spirometry and deep breathing exercise, during surgery and two, six and ten hours after surgery after using incentive spirometry and deep breathing exercise. The control group is also registered with the same pattern.
Method of measurement
The way to measure blood oxygen saturation is by a portable pulse oximetry device.

2

Description
Heart rate
Timepoint
Heart rate is recorded two hours before surgery after using incentive spirometry and deep breathing exercise, during surgery and two, six and ten hours after surgery after using incentive spirometry and deep breathing exercise. The control group is also registered with the same pattern.
Method of measurement
The way to measure the heart rate is by a portable pulse oximetry device.

3

Description
Blood pressure
Timepoint
Blood pressure is recorded two hours before surgery after using incentive spirometry and deep breathing exercise, during surgery and two, six and ten hours after surgery after using incentive spirometry and deep breathing exercise. The control group is also registered with the same pattern.
Method of measurement
Blood pressure is measured by a sphygmomanometer.

4

Description
Blood PH
Timepoint
The level of blood PH is recorded two hours before the operation after using incentive spirometry and deep breathing exercise, during the operation and two, six and ten hours after the operation after using incentive spirometry and deep breathing exercise.The control group is also registered with the same pattern.
Method of measurement
Blood PH is determined by venous blood gas analysis.

5

Description
Blood carbon dioxide
Timepoint
Blood carbon dioxide level is recorded two hours before the operation after using incentive spirometry and deep breathing exercise, during the operation and two, six and ten hours after the operation after using incentive spirometry and deep breathing exercise. The control group is also registered with the same pattern.
Method of measurement
Blood carbon dioxide is determined by venous blood gas analysis.

Secondary outcomes

1

Description
Pneumonia
Timepoint
The incidence of pneumonia after the surgery is checked by referring to the patient's file and examination of clinical symptoms by an expert up to two weeks.
Method of measurement
Refer to the patient's file and check the clinical symptoms by the specialist

2

Description
Atelectasis
Timepoint
The incidence of atelectasis after the surgery is checked by referring to the patient's file and examination of clinical symptoms by an expert up to two weeks.
Method of measurement
Refer to the patient's file and check the clinical symptoms by the specialist.

3

Description
Length of hospitalization
Timepoint
The length of hospitalization is checked after the patient's discharge and by referring to the patient's file.
Method of measurement
Referring to the patient's file.

Intervention groups

1

Description
Intervention group: in the first intervention group, the intervention method is incentive spirometry. In this method, patients are placed in a sitting or semi-sitting position, and an incentive spirometry tube is placed in their mouth. They inhale and then hold their breath for 3-5 seconds and slowly exhale through the mouth as they remove the device. The patient performs this exercise 5 times two hours before the operation, two, six and ten hours after the operation. The average maximum inspiratory volume of the patient is recorded by incentive spirometry.
Category
Prevention

2

Description
Control group: in the control group, only routine cares will be done. Usual hospital cares include : drug treatment, checking vital signs, controlling patients' pain and encouraging patients to breathe deeply.
Category
Prevention

3

Description
Intervention group: the second intervention group, the intervention method is deep breathing exercise. In this method, the patient is sitting or semi-sitting, taking slow and deep breaths through the nose, at the same time, he presses the upper part of the abdomen with a pillow to reduce the pain. The patient inhales and then holds his breath for 3 to 5 seconds and exhales through pursed lips by squeezing the abdominal muscles. The patient performs this exercise 5 times two hours before the operation and two, six and ten hours after the operation.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Fereshteh Farzanmehr
Street address
Imam Khomeini Hospital Complex, Dr. Gharib St, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2386
Email
Imamhospital@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahimnejad
Street address
Research and Technology Vice-Chancellor, Third Floor, Moalem Square, Building No.2, Mazandaran University of Medical Sciences and Healthcare Services, Sari
City
Sari
Province
Mazandaran
Postal code
1234568952
Phone
+98 11 4874 3448
Email
jmums@mazums.ac.ir
Web page address
http://jmums.mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fereshteh Farzanmehr
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Num. 136 , Second Floor, C1 Building, Sarvestan Residential Complex, Western Arghavan St.,Dadman Blvd, Sana't Squ., Tehran
City
Tehran
Province
Tehran
Postal code
1468613831
Phone
+98 21 2208 6052
Fax
Email
Fereshteh.Farzanmehr@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fereshteh Farzanmehr
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Num. 136 , Second Floor, C1 Building, Sarvestan Residential Complex, Western Arghavan St.,Dadman Blvd, Sana't Squ., Tehran
City
Tehran
Province
Tehran
Postal code
1468613831
Phone
+98 21 2208 6052
Fax
Email
Fereshteh.Farzanmehr@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fereshteh Farzanmehr
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Num. 136 , Second Floor, C1 Building, Sarvestan Residential Complex, Western Arghavan St.,Dadman Blvd, Sana't Squ., Tehran
City
Tehran
Province
Tehran
Postal code
1468613831
Phone
+98 21 2208 6052
Fax
Email
Fereshteh.Farzanmehr@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Individual data of study participants is considered and all data can be shared after de-identification of individuals.
When the data will become available and for how long
The access period starts 6 months after publication of results
To whom data/document is available
Our data will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Our data will only be available to researchers working in academic and scientific institutions. Statistical analysis is possible on the data and they can use email to send requests.
From where data/document is obtainable
Applicants can contact Fereshte Farzanmehr at the following address: Email: Fereshteh.Farzanmehr@gmail.com Postal code: 1468613831 Phone: 09128347148
What processes are involved for a request to access data/document
After receiving the request by the researcher, the documents will reach the applicant within two weeks at most.
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