This study aimed to investigate the effects of continuous positive airway pressure masks on hemodynamic parameters after open heart surgery.
A randomized controlled trial was conducted on 72 patients undergoing open heart surgery that were randomly assigned into two groups of intervention (n = 36) and control (n = 36) in Iran, 2015. After the extubation, a continuous positive airway pressure mask (with a force of 5 cmH2o) used for patients in the intervention group (30 minutes every eight hours for five consecutive times).
Measurements: A checklist was used to record the hemodynamic parameters(SBP,DBP,MAP,CVP,HR) and ABG of all patients 10 minutes before and after each intervention. pulmonary complication(pneumonia, atelectasia, plural effusion)was record in end of study. Data analysis was performed using Kolmogorov-Smirnov test, t-test and chi-square.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902013146N2
Registration date:2016-08-18, 1395/05/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-18, 1395/05/28
Registrant information
Name
Ismail Azizi-Fini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
azizi-es@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan university of medical science
Expected recruitment start date
2015-12-10, 1394/09/19
Expected recruitment end date
2016-06-07, 1395/03/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of CPAP masks on hemodynamic parameters, arterial blood gas and pulmonary complications in patients after open heart surgery
Public title
The effect of CPAP masks on hemodynamic parameters, arterial blood gas and pulmonary complications in patients after open heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age > 18 years; having an elective of surgery; undergoing cardiopulmonary bypass (CPB) during cardiac surgery; having an EF over 40%; having at least a chest tube in the pleural cavity; being under mechanical ventilation for less than 12 hours after the surgery. Exclusion criteria: no need for medications such as epinephrine, dopamine, and dobutamine at the start of the study; lacking a definite diagnosis of COPD and asthma.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics commete of Kashan University of Medical Sciences
Street address
Blv Ghotb Ravandi, Blv Pezeshk, Kashan University of Medical Sciences
City
kashan
Postal code
8715981151
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
Ir.KAUMS.REC.1394.116
Health conditions studied
1
Description of health condition studied
plural effusion
ICD-10 code
J91
ICD-10 code description
Pleural effusion in conditions classified elsewhere
2
Description of health condition studied
Atelectasis
ICD-10 code
J98
ICD-10 code description
Pulmonary collapse
3
Description of health condition studied
pneumonia
ICD-10 code
J15
ICD-10 code description
Bacterial pneumonia, not elsewhere classified
4
Description of health condition studied
Hemodynamic
ICD-10 code
I99
ICD-10 code description
Other and unspecified disorders of circulatory system
Primary outcomes
1
Description
Diastolic BP
Timepoint
pre and 10 min post Intervention
Method of measurement
monitor
2
Description
Heart Rate
Timepoint
pre and 10 min post Intervention
Method of measurement
monitor
3
Description
Centeral Venous Pressure
Timepoint
pre and 10 min post Intervention
Method of measurement
monitor
4
Description
Atelectasy
Timepoint
end of Study
Method of measurement
CXRay
5
Description
Systolic BP
Timepoint
pre and 10 min post Intervention
Method of measurement
monitor
6
Description
Plural Effusion
Timepoint
end of Study
Method of measurement
CXRay
7
Description
Mean arterial pressure
Timepoint
pre and 10 min post Intervention
Method of measurement
monitor
8
Description
pneumonia
Timepoint
end of Study
Method of measurement
CXRay
Secondary outcomes
1
Description
Ejection Fraction
Timepoint
end of study
Method of measurement
Echocardiography
Intervention groups
1
Description
. After the extubation, a continuous positive airway pressure mask (with a force of 5 cmH2o) used for patients in the intervention group (30 minutes every eight hours for five consecutive times).
Category
Treatment - Devices
2
Description
control group:NO treat ment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research OF Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidi
Street address
Blv Ghotb Ravandi, Blv Pezeshk, Kashan University of Medical Sciences
City
Kashan
Grant name
7153
Grant code / Reference number
94116
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research OF Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Ismail Azizi-Fini
Position
PhD Candidate of Nursing Education
Other areas of specialty/work
Street address
Blv Ghotb Ravandi, Blv Pezeshk, Kashan University of Medical Sciences
City
Kashan
Postal code
8715981151
Phone
+98 31 5554 0021
Fax
+98 31 5554 6633
Email
azizi-es@kaums.ac.ir, azizifinies@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Ismail Azizi-Fini
Position
PhD candidate of Nursing education
Other areas of specialty/work
Street address
Blv Ghotb Ravandi, Blv Pezeshk, Kashan University of Medical Sciences
City
Kashan
Postal code
8715981151
Phone
+98 31 5554 0021
Fax
+98 31 5554 6633
Email
azizi-es@kaums.ac.ir, azizifinies@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Ismail Azizi-Fini
Position
PhD.Condidate of Nursing
Other areas of specialty/work
Street address
Blv Ghotb Ravandi, Blv Pezeshk, Kashan University of Medical Sciences
City
Kashan
Postal code
8715981151
Phone
+98 31 5554 0021
Fax
+98 31 5554 6633
Email
azizifinies@yahoo.com, azizi-es@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)