Comparison of the Effectiveness of Nursing Care Bundles with Routine Care on the Outcomes of Chest Tube Drainage in Patients Undergoing Open Heart Surgery
determine the Effects of Nursing care bundles on the outcomes of chest tubes drainage in patients undergoing cardiac surgery
Design
A randomized, controlled, double-blind, placebo-controlled clinical trial
Settings and conduct
Patients undergoing open heart surgery in the cardiac care unit of Baqiyatallah hospital
Samples are selected by available sampling method and then randomly divided into intervention and control groups. The control group received no intervention and routine procedure was performed. But in the intervention group the care package is administered and the requested information is recorded in the checklist
Blindness is one-way
Participants/Inclusion and exclusion criteria
1) Inclusion criteria are to be included in the study: Willingness to Participate in the Study, Age Range 18 and Under 70 Years, Elective Open Heart Surgery (Elective) and Left Ventricular Ejection Fraction Greater than 30%.
2) exclusion criteria are to be included: High-dose inotropic intake,
Re-surgery, Previous coagulation problems and Has Renal failure.
Intervention groups
In the control group, no intervention was performed and usual and routine procedures were done.
In the intervention group the care package is administered and the requested information is recorded in the checklist.
Package includes the appropriate height of a patient bed, respiratory training and piping to mechanical ventilation drainage connection to suction
Main outcome variables
The main outcomes are: Atelectasis, Pleural effusion, Pericardial effusion, Arterial blood gases, Drainage.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200114046124N1
Registration date:2020-05-23, 1399/03/03
Registration timing:retrospective
Last update:2020-05-23, 1399/03/03
Update count:0
Registration date
2020-05-23, 1399/03/03
Registrant information
Name
HamidReza Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2244 1099
Email address
hra9908@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-06, 1398/09/15
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Nursing Care Bundles with Routine Care on the Outcomes of Chest Tube Drainage in Patients Undergoing Open Heart Surgery
Public title
The Effect of Nursing Care Bundles on the Outcomes of Chest Tube Drainage in Patients Undergoing Open Heart Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to Participate in the Study
Age Range 18 and Under 70 Years
Elective Open Heart Surgery (Elective)
Left Ventricular Ejection Fraction Greater than 30%
Exclusion criteria:
High-dose inotropic intake
Re-surgery
Previous Coagulation Disorders
Has Renal failure
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Given that the participants in this study (patients) were unaware of the study group (intervention and control), on the other hand, the group of evaluators (anesthesiologist) to reduce the bias related to the intervention and evaluation of the consequences and its possible impact on The results of the study were also unknown to the study group.
But given the awareness of other members of the research team about the nature of the intervention and the study groups, the study is ultimately single blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
Ethics committee of Baqiyatallah University of Medical Sciences, َAfter Sheikh Bahayi Street, Mulla Sadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1698749511
Approval date
2019-11-12, 1398/08/21
Ethics committee reference number
IR.BMSU.Rec.1398.272
Health conditions studied
1
Description of health condition studied
Patients with valve coronary artery disease or both of them
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage of patients with atelectasis, pleural effusion and pericardial effusion
Timepoint
After open heart surgery and entering the cardiac care unit until being transferred from the ward
Method of measurement
checking chest x-ray and clinical signs of patients by Anesthesiologist
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Perform routine actions in the section without additional work
Category
N/A
2
Description
Intervention group: Care bundles consisting of ; 1- the appropriate height to the bed so that the pipes are not hung from the bed and can be used to maximize Gravity Drainage 2-Using a suitable mechanical ventilation pip Zinc number 5 and after separation using deep breathing exercises and effective coughing 3-Binding of pipes to Ganco suction