the effect of respiratory muscle training on reducing the duration of mechanical ventilation and the length of stay in the hospital and ICU
Design
After the referral, the written consent of the subjects was obtained.The breathing test was done before and after the intervention for patients.
intervention: Patients return to the recovery center 7-5 times a week, at least 2 weeks before surgery. For 15- 30 minutes, exercise breathing exercises with 10-60% strength. The maximum individual respiratory rate (Pimax) should be exercised under the supervision of a physician or physiotherapist. At the first session patients were trained regarding the respiratory muscle training which should do at home. After one week patients referred to evaluate and fix the problems which they faced.At the end of two weeks, pimax (maximum respiratory capacity) was measured.
Settings and conduct
Permuted Block randomization method used. Then divided in two groups including muscle training and pulmicort combivent, and control group which received only pulmonary combivent and both groups evaluated by breathing test and SF36 questionnaire after the study.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Age over 18 years
Patients who are at the risk of postoperative pulmonary complications
are on the same list of surgical procedures for switching vessels and valves.
exclusion criteria:
Age over 70 year
respiratory or pulmonary infections
lack of cooperation in the practice
lung surgery history
Cardiovascular instability and exercise induced bronchospasm
The use of immunosuppressive drugs 30 days before surgery
Spontaneous pneumothorax history
Intervention groups
Patients go to the recovery center 7-5 times a week, at least 2 weeks before surgery. For 15-30 minutes, exercise breathing exercises with 10-60% strength (Pimax)
Main outcome variables
Maximum strength of the respiratory muscles
General information
Reason for update
Acronym
تقویت عضلات تنفسی قبل از جراحی قلب
IRCT registration information
IRCT registration number:IRCT20180625040234N1
Registration date:2018-07-17, 1397/04/26
Registration timing:prospective
Last update:2018-07-17, 1397/04/26
Update count:0
Registration date
2018-07-17, 1397/04/26
Registrant information
Name
Hossein Ahmadi tafti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9733
Email address
mahdavi-a@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of respiratory muscle training on hospital and ICU stay in patients undergoing coronary and valves surgery
Public title
The effect of respiratory muscle training on hospital and ICU stay in patients undergoing coronary and valves surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Patients who are at the risk of postoperative pulmonary complications
are on the same list of surgical procedures for switching vessels and valves.
The study is conducted in the waiting period for surgery and the results will be measured before surgery. The risk group includes patients over 70 years of age and a history of diabetes and history of smoking and pulmonary disease, (COPD), BMI greater than 27, and impaired pulmonary function (FEV1 <80% and FEZ1 / FVC <70%).
Exclusion criteria:
Age over 70 years
respiratory or pulmonary infections
lack of cooperation in the practice
lung surgery history
Cardiovascular instability and exercise induced bronchospasm
The use of immunosuppressive drugs 30 days before surgery
Spontaneous pneumothorax history
Age
From 18 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
190
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals were selected using Permuted Block randomization method. then were divided in two groups including muscle training and pulmicort combivent, and control group which will receive only pulmonary combivent and both groups will be evaluated by breathing test and SF36 questionnaire after the study.
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
School of medicine - Tehran university of medical sciences
Street address
Poursina ave., 6th floor, school of Medicine, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
8415683111
Approval date
2018-06-13, 1397/03/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.125
Health conditions studied
1
Description of health condition studied
Mechanical complication of coronary artery bypass and valve
ICD-10 code
T82.2
ICD-10 code description
Mechanical complication of coronary artery bypass graft and biological heart valve graft
Primary outcomes
1
Description
Maximum strength of the respiratory muscles
Timepoint
Before and after breathing exercises
Method of measurement
Using the power breathe device
2
Description
Duration of admission to ECU
Timepoint
Since the transfer to ECU until clearance
Method of measurement
Patient File
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Inspiratory muscle training (IMT) and treated with pulmicort and combivent inhaller.Patients return to the recovery at least 2 weeks before surgery.At the first session patients were trained regarding the respiratory muscle training which should do at home and pimax (maximum respiratory capacity) was measured. After one week patients referred to evaluate and fix the problems which they faced.At the end of two weeks, pimax (maximum respiratory capacity) was measured.
Category
Rehabilitation
2
Description
Control group: pimax (maximum respiratory capacity) was measured and treated with pulmicort and combivent inhaller.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran heart center
Full name of responsible person
Dr.Sepideh Niyazi
Street address
Tehran Heart Center,North Kargar St.,Tehran
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9630
Email
hosseinahmaditafti@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Street address
Poursina ave., 6th floor, school of Medicine, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 6641 8466
Fax
Email
sepide.niyazi.sn@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
80
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
Tehran University of Medical Sciences
Full name of responsible person
Sepideh Niyazi
Position
Sport Medicine
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Tehran Heart Center,North Kargar St.,Tehran
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 88 0296 0069
Email
sepide.niyazi.sn@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Ahmadi Tafti
Position
CARDIAC SURGEONS
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Tehran Heart Center,North Kargar St.,Tehran
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 0218802973
Email
hosseinahmaditafti@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sepideh Niyazi
Position
Sport Medicine
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Tehran Heart Center,North Kargar St.,Tehran
City
Tehran
Province
Tehran
Postal code
713138 1411
Phone
+98 88 0296 0069
Email
sepide.niyazi.sn@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
It is possible to share the information regarding the main consequence .
When the data will become available and for how long
The publication of this research work will start after the end of the year 1399.
To whom data/document is available
Our study data will be available to researchers and all medical doctors and medical students.
Under which criteria data/document could be used
It is authorized to use this scheme for upcoming research works and promoting the patients' treatment.
From where data/document is obtainable
Applicants can visit the doctor Niyazi at Tehran Heart Center
What processes are involved for a request to access data/document
After finishing the work and publishing the article the work can be referred and cited.