Investigating the effect of removal of chest tube at the end of the exhalation on the severity of pain and pulmonary complications after coronary artery bypass graft surgery.
Effect of removal of chest tube at the end of the exhalation on the severity of pain and pulmonary complications after coronary artery bypass graft.
Design
A clinical trial with a control group, with parallel groups of 60 patients, by random assignment based on binary permutation blocks.
Settings and conduct
This study will be done at the Farshchian heart of Hamedan in patients undergoing coronary artery bypass graft. All participants will be taught how to report pain and shortness of breath using the VAS ruler and the scale of the Borg and how to perform valsalva maneuver at the end of the dementia and exhalation. It is described to patients in the tail and exhalation group when the researcher says that they have taken 2-3 deep breaths and by doing a deep tail or undergoing a deep exhalation when the chest tube exits, the amount of pain, shortness of breath expresses the specified intervals and the occurrence of pneumothorax is measured one hour later.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients undergo cardiopulmonary bypass surgery؛ Having two chest drainage tubes simultaneously at a distance close to each other.
Exclusion criteria: Patient dissatisfaction to participate in the study.
Intervention groups
The amount of pain, shortness of breath and oxygen saturation of the arterial blood will be measured immediately before - 15 minutes later - 30 minutes later and one hour after the tube is exhausted. The occurrence of pneumothorax will be measured one hour later.
Main outcome variables
Severe pain; shortness of breath; pneumothorax; arterial blood oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181031041518N1
Registration date:2019-01-23, 1397/11/03
Registration timing:registered_while_recruiting
Last update:2019-01-23, 1397/11/03
Update count:0
Registration date
2019-01-23, 1397/11/03
Registrant information
Name
Akbar Gohari kamel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
a.gohari@edo.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-30, 1397/09/09
Expected recruitment end date
2019-03-29, 1398/01/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of removal of chest tube at the end of the exhalation on the severity of pain and pulmonary complications after coronary artery bypass graft surgery.
Public title
The effect of removing the chest tube in the end of expiration on the severity of pain and pulmonary complications after surgery.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Awful patients undergoing coronary artery bypass graft surgery by cardiopulmonary bypass method
Having two chest drainage chambers at the same distance to each other
At least 24 hours have passed since the tubes were imported.
Lack of diabetes and neuropathies caused by other diseases
Ability to speak and understand Persian language
Lack of hearing impairment
Having hemodynamic stability (systolic blood pressure greater than 90 mmHg, lack of dangerous dysrhythms)
Exclusion criteria:
Valve Replacement Surgery
Patients undergoing cardiac emergency surgery
Patients with diabetes
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, the patients were registered according to the sample size (120) and according to theinclusion criteria, and using the blocking method (using a two-block method, two letters A and B with different permutations we place blocks in blocks and randomly select 60 blocks and assign each block to 2 people) will be assigned to two groups
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Quasi- Experimental study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamedan University of Medical Sciences
Street address
BIvd fahmideh-Opposite the People's Park-Hamedan University of Medical Sciences-School of Nursing and Midwifery
City
Hamedan
Province
Hamadan
Postal code
65178-38698
Approval date
2018-10-12, 1397/07/20
Ethics committee reference number
IR.UMSHA.REC.1397.458
Health conditions studied
1
Description of health condition studied
Atherosclerotic heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Intensity of pain
Timepoint
Immediately before, immediately after, 15 minutes and an hour after the chest tube exits.
Method of measurement
VAS(Visual Analogue Scale)
Secondary outcomes
1
Description
Dyspnea
Timepoint
Immediately before, immediately after, 15 minutes and an hour after the chest tube exits.
Method of measurement
Borg's Facilitated Criterion.
2
Description
Amount of spo2
Timepoint
Immediately before, immediately after, 15 minutes and an hour after the chest tube exits.
Method of measurement
Monitor device available on the patient's bedside.
3
Description
Pneumothorax
Timepoint
َAn hour after the chest tube exits.
Method of measurement
Chest X-ray
Intervention groups
1
Description
The intervention group: In this study, patients are randomly placed under the outflow of the thoracic tube at the end of exhalation. The sampling procedure continues to complete the number of samples. When the researcher said that the patient drew a breath of 2 - 3 deeply breaths and exhaled a deep breath during the outflow of the chest tube (a Valsalva maneuver at the end of exhalation). It receives if it is prescribed for a patient with a narcotic drug. The intensity of pain in the thoracic cavity, the severity of the shortness of breath and the amount of spo2 is measured over the three-time frame: immediately after - 15 minutes and 1 hour after the chest tube pipeline is removed. To measure pneumothorax 1 hour after the departure the chest tube (chest x-ray) and compared with the last CXR of the patient before the extubation of the chest tube by a specialist.
Category
Treatment - Other
2
Description
Control group: Includes patients who routinely withdraw from the chest tube at the tail end (performing valsalva maneuver at the tail end). In this group, all the above tutorials are also given, the variables are recorded at the same time but at the end of the tail and compared to the end of the results.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Heart Hospital of Farshchian Hamedan.
Full name of responsible person
Akbar Gohari Kamel
Street address
Shahid Fahmideh Blvd - Farshchian Cardiology and Cardiology Center.
City
Hamedan
Province
Hamadan
Postal code
65178-38698
Phone
+98 81 3838 1740
Email
hcvc@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohsen Salavati
Street address
Fahmideh BIvd- Opposite the People's Park-Hamedan University of Medical Sciences- School of Nursing and Midwifery.
City
Hamedan
Province
Hamadan
Postal code
65178-38698
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
midnurse@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Akbar Gohari Kamel
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Fahmideh BIvd- Opposite the People's Park-Hamedan University of Medical Sciences- School of Nursing and Midwifery.
City
Hamedan
Province
Hamadan
Postal code
65178-38698
Phone
+98 81 3311 5516
Email
a.gohari@edo.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohsen Salavati
Position
Master of Science
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Fahmideh BIvd - Opposite the People's Park-Hamedan University of Medical Sciences- School of Nursing and Midwifery.
City
Hamedan
Province
Hamadan
Postal code
65178-38698
Phone
+98 81 3838 0447
Email
salavatimohsen42@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Akbar Gohari Kamel
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Fahmideh BIvd - Opposite the People's Park-Hamedan University of Medical Sciences- School of Nursing and Midwifery.
City
Hamedan
Province
Hamadan
Postal code
65178-38698
Phone
+98 81 3311 5516
Email
a.gohari@edo.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
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
Individual data of participants after unidentifiable individuals; and the main implications of the study.
When the data will become available and for how long
After completing the study.
To whom data/document is available
Researchers working in scientific institutions
Under which criteria data/document could be used
Researchers working in scientific institutions
From where data/document is obtainable
00988133115516
What processes are involved for a request to access data/document