Determining the effect of preoperative respiratory physiotherapy on pulmonary complications in patients undergoing heart valve surgery
Design
Clinical trial with control and experience group. About 80 patients. The blocking method will be used as random quadruple blocks.
Settings and conduct
This study is a randomized clinical trial that will be performed at the Shahid Rajaei Cardiovascular Training, Treatment and Research Center.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Patients who are candidates for heart valve surgery (mitral, aortic or tricuspid)
2) Age 18 to 65 years
3) Satisfaction to participate in the study
4) No history of heart surgery
Intervention groups
Due to the fact that respiratory physiotherapy is performed in most centers after surgery and not enough information is available on the effects of preoperative respiratory physiotherapy on faster recovery and control of complications, the present study aimed to investigate the effect of preoperative respiratory physiotherapy on complications. Pulmonary surgery will be performed in patients undergoing heart surgery.Intervention group: The researcher will teach the experimental group how to perform daily respiratory physiotherapy for 20 minutes from 15 days before surgery and will provide them with a pamphlet on how to perform the exercises. Incentive spirometry will also be provided to the experimental group. The experimental group will perform scheduled respiratory physiotherapy before surgery Control group: will receive routine hospital treatment, including postoperative breathing exercises and spirometry.
Main outcome variables
Arterial blood gases
Mean respiratory volume using incentive spirometry
• Pneumonia
• atelectasis
Intubation time
• ICU admission time
• Time of hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211119053108N1
Registration date:2022-01-03, 1400/10/13
Registration timing:registered_while_recruiting
Last update:2022-01-03, 1400/10/13
Update count:0
Registration date
2022-01-03, 1400/10/13
Registrant information
Name
Hamed Bayati shamseki
Name of organization / entity
Shahid rajaei heart center
Country
Iran (Islamic Republic of)
Phone
+98 21 3421 5785
Email address
hamedbayati700@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-31, 1400/10/10
Expected recruitment end date
2022-03-01, 1400/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Respiratory Physiotherapy before Surgery on Pulmonary Complications in Patients Undergoing Cardiac valve Surgery
Public title
Respiratory Physiotherapy before Surgery and Pulmonary Complications
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for heart valve surgery (mitral, aortic or tricuspid)
No history of heart surgery
No neuromuscular disorders or cognitive disorders
No emergency surgery
Exclusion criteria:
Dissatisfaction with participating in the study
Be lung and kidney healthy
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The candidate for heart valve surgery will select the available method based on the inclusion criteria and randomly assign a block to one of the experimental (40) or control (40) groups. For random assignment to the experimental or control group, the blocking method will be used in the form of four random blocks. The letter A belongs to the intervention group and the letter B belongs to the control group. Based on. The sample size is 80 people. Blocking is used in the form of four blocks.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Rajaei Heart Center
Street address
Tehran - Vali Asr St. (AS) - Next to Mellat Park - Corner of Niayesh Shahid Rajaei Cardiovascular Training, Research and Treatment Center
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2021-03-09, 1399/12/19
Ethics committee reference number
IR.RHC.REC.1399.141
Health conditions studied
1
Description of health condition studied
Pulmonary complications . cardiovascular patients
ICD-10 code
۰
ICD-10 code description
۰
Primary outcomes
1
Description
Determining and comparing the mean results of arterial blood gases in the intervention and control groups, before surgery and three days after surgery
Timepoint
Before surgery and 3 days later
Method of measurement
Measurement using arterial blood gas test results
2
Description
• Determination and comparison of mean respiratory volume using incentive spirometry in the intervention and control groups, before, three days and six days after surgery
Timepoint
Before surgery and 3 days later and 6 days later
Method of measurement
Based on the volume determined by the incentive spirometer
3
Description
Determination of clinical and radiographic symptoms of pneumonia and atelectasis in the intervention group compared with the control group before, three days and six days after surgery
Timepoint
Before surgery and 3 days later and 6 days later
Method of measurement
Based on clinical examination and chest x-ray
4
Description
Determining and comparing the mean duration of intubation and hospitalization time in the intensive care unit and hospitalization in the intervention and control groups
Timepoint
Duration of hospitalization
Method of measurement
Based on hospital information
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The start of TFS physiotherapy is 15 days before surgery. In the clinic of Shahid Rajaei Hospital, pamphlets related to breathing exercises and incentive spirometry are provided to the patient and the necessary training on how to perform respiratory physiotherapy and use of incentive spirometry is given through lectures and shows. The patient is given. To ensure the effectiveness of the training, the patient is asked to once use the method of using incentive spirometry and how to perform respiratory physiotherapy in the presence of the researcher, and in case of problems at any stage, the training will be repeated.Preoperative physiotherapy techniques for patients will include the following: 1. Breathing exercises consisting of 10 attempts at deep breathing and diaphragmatic breathing 2. 10 breathing lip buds 3. Neck and shoulder exercises with emphasis on chest rehabilitation 4. Muscle tension exercises 5. Exercises to strengthen the muscles responsible for moving the shoulders back and forth (Shakoori et al., 2015). 6. Use of incentive spirometry (IS) (Respiflow ™ FS) and effective cough
Category
Treatment - Devices
2
Description
Control group: The usual hospital treatments are performed on the control group
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Heart Center
Full name of responsible person
Dr. Saeed Hosseini
Street address
Tehran - Vali Asr St. (AS) - Next to Mellat Park - Corner of Niayesh Shahid Rajaei Cardiovascular Training, Research and Treatment Center