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Evaluating the effects of respiratory rehabilitation before mitral valve surgery on the prevention of respiratory functions and complications and length of stay during admission in intensive car

Protocol summary

Study aim
Determination of the effect of respiratory training prior to mitral valve surgery in the prevention of impaired function and respiratory complications and duration of admission to special care units
Design
Clinical trial with control group, with parallel groups, blind, randomized
Settings and conduct
Sampling from patients referring to the Shahid Rajaee Cardiology Center in Tehran, which requires a mitral valve surgery (with / without need for trecospine valve surgery) to be diagnosed by a specialist. Patients will be randomly assigned to one of the two groups. One-way blind is used, and the Surgeonis unaware of the control.
Participants/Inclusion and exclusion criteria
The criteria for admission to the project are: at least 18 years of age, left ventricular drainage fraction (LVEF) under 55% that will be measured by echocardiography, and no recent surgery of the heart or chest, and no musculoskeletal disorders and asthma And chronic obstructive pulmonary disease. Also, the exclusion criteria of the project are: recent surgery of the heart or chest, musculoskeletal disorders, asthma, chronic obstructive pulmonary disease (COPD), chronic pulmonary disease such as bronchitis, recent pulmonary infection, use of suppressing drugs Safety and non-consent of the patient by entering the plan and the terms of the consent form.
Intervention groups
For 30 days before surgery, the group carries out a non-exercise physiotherapy intervention (using a power brathe machine). The control group does not perform respiratory physiotherapy.
Main outcome variables
Duration of hospitalization in the field of intensive care and postoperative complications of mitral valve surgery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180430039480N1
Registration date: 2018-07-30, 1397/05/08
Registration timing: registered_while_recruiting

Last update: 2018-07-30, 1397/05/08
Update count: 0
Registration date
2018-07-30, 1397/05/08
Registrant information
Name
Mandana Mashhadijafari
Name of organization / entity
University of Haspital Rajaee
Country
Iran (Islamic Republic of)
Phone
+98 21 7715 0680
Email address
mandanajafari1348@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-10, 1397/03/20
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of respiratory rehabilitation before mitral valve surgery on the prevention of respiratory functions and complications and length of stay during admission in intensive car
Public title
Evaluating the effects of respiratory rehabilitation before mitral valve surgery on the prevention of respiratory functions and complications and length ofstay during admission in intensive car
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The criteria for entering the plan are: at least 18 years of age, left ventricular ejection fraction (LVEF) below 55% that will be measured by echocardiography, and no recent surgery of the heart or chest, and no musculoskeletal disorders and Asthma and Chronic Obstructive Pulmonary Disease
Exclusion criteria:
Exit criteria for a patient include: recent surgery of the heart or chest, musculoskeletal disorders, asthma, chronic obstructive pulmonary disease (COPD), chronic pulmonary disease, such as bronchitis, recent pulmonary infections, use of suppressing drugs and Disagreement with the patient entering the plan and the terms of the consent form
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomize block.
Blinding (investigator's opinion)
Single blinded
Blinding description
The only surgery that performs mitral valve surgery is the unconsciousness of the patient's involvement in the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
IR.RHC.REC.1397.003
Street address
Valiasr Street. Corner of prayer. Shahid Rajaee Cardiovascular Research Center
City
Tehran
Province
Tehran
Postal code
1741746194
Approval date
2018-04-28, 1397/02/08
Ethics committee reference number
IR.RHC.REC.1397.003

Health conditions studied

1

Description of health condition studied
Miter's disease of the heart
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Duration of admission to the intensive care unit
Timepoint
30 days
Method of measurement
Hospital hours in the intensive care unit

Secondary outcomes

1

Description
Function and respiratory complications
Timepoint
The examination is done prior to the onset of intervention and 30 days of respiratory physiotherapy.
Method of measurement
6 minutes walk and lung radiography

Intervention groups

1

Description
The intervention group performs respiratory physiotherapy with the power brath before the 30-day operation.
Category
Prevention

2

Description
Control group:The control group receives all necessary measures and care. They do not receive pre-operative physiotherapy.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajaee Cardiology Hospital Tehran
Full name of responsible person
Mandana Mashhadi Jafari
Street address
Valiasr Street. The Hospital of Shahid Rajaee Cardiology Tehran
City
Tehran
Province
Tehran
Postal code
1741746194
Phone
+98 21 23921
Email
mandanajafara1348@rhc.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shaheed Rajaee cardiovascular research center
Full name of responsible person
Dr. Majid Maleki
Street address
Valiasr Street, Corner of the Avenue of Prayer
City
TEHRAN
Province
Tehran
Postal code
1741746194
Phone
+98 21 23921
Email
majid33@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shaheed Rajaee cardiovascular research center
Proportion provided by this source
100
Public or private sector
Private
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
Shahid Rajaee Cardiovascular Research Center Tehran
Full name of responsible person
Mandana Mashhadi Jafari
Position
Student Masters Degree
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Valiasr Ave. Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1741746194
Phone
+98 21 23921
Email
mandanajafari1348@rhc.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Research Center for Therapeutic Therapy for Heart and Rajaji Teva in Tehran
Full name of responsible person
Mandana Mashhadi Jafari
Position
Student Master's Degree Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Valiasr Ave. Tehran University of Medical Science
City
Tehran
Province
Tehran
Postal code
1741746194
Phone
+98 21 23921
Email
mandanajafari1348@rhc.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Research Center for Cardiovascular Research, Rajai University of Tehran
Full name of responsible person
ماندانا مشهدی جعفری
Position
Student Master's Degree Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Valiasr Street. The City of Rajaee Heart Hospital Tehran
City
Tehran
Province
Tehran
Postal code
1741746194
Phone
+98 21 23921
Email
mandanajafari1348@rhc.ac.ir

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
No more information
Study Protocol
No - There is not 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
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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