The purpose of this study is to compare invasive and noninvasive methods of blood gas monitoring during the weaning process in patients undergoing cardiac surgery.This clinical trial will be conducted in two groups. 60 patients who are undergoing open heart surgery who have our study inclusion criteria will be randomly allocated into two groups of control and intervention. After adequate explanations, written informed consent will be obtained from patients. After the operation and transferring the patients to the intensive care unit, capnography will be used instead of the arterial blood gas for the monitoring of patients in experimental group and then the ventilator Management and setting change will be done based on capnography and pulse oximetery. The weaning in the control group will be done based on hospital routines. Weaning time and arterial blood gases will be compared between groups.
General information
Acronym
Using the capnography during the weaning process
IRCT registration information
IRCT registration number:IRCT201701016778N6
Registration date:2017-03-03, 1395/12/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-03, 1395/12/13
Registrant information
Name
Seyed Tayeb Moradian Vafaei
Name of organization / entity
School of nursing and midwifery, Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 4258
Email address
t-moradian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Nursing faculty, Baghyattallah University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between invasive and noninvasive methods of blood gas monitoring on weaning process outcomes in patients undergoing cardiac surgery
Public title
non invasive monitoring during weaning from mechanical ventilation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients with non-emergency cardiac surgery; age greater than 20 and less than 70 years; negative history of previous cardiac surgery; Exclusion criteria were: severe hemodynamic impairment; has a heart rate less than 60 beats per minute; Drainage more than 300 ml in the first hour
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Science
Street address
Baqiyatallah University of Medical Sciences, Sheikh Bahaei St, Vanak Square, Tehran, Iran
City
Tehran
Postal code
1234567890
Approval date
2016-10-03, 1395/07/12
Ethics committee reference number
IR.Bmsu.REC.1395.141
Health conditions studied
1
Description of health condition studied
weaning from mechanical ventilator
ICD-10 code
Z51.8
ICD-10 code description
Other specified medical care
Primary outcomes
1
Description
Weaning Time
Timepoint
Since enterance to ICU until extubation
Method of measurement
Using the Clock
Secondary outcomes
1
Description
Vital signs
Timepoint
Hour Since entering until extubation
Method of measurement
Using Patient Monitoring
2
Description
the amount of arterial carbon dioxide tention
Timepoint
ICU enterance and during the extubation
Method of measurement
using the arterial blood gas analysis
Intervention groups
1
Description
In the intervention group for monitoring during the weaning process, capnography and pulseoximetery are used instead of arterial blood gasses.
Category
Other
2
Description
The control group will received no intervention and hospital routine care will be done.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
jamaran Heart Hospital
Full name of responsible person
Seyed Mohammad Saeid Ghiasi
Street address
jamaran Heart hospital,jamaran st, Niavaran St, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nursing faculty, Baghyattallah University of Medical Sciences
Full name of responsible person
Morteza Khaghanizadeh
Street address
Tehran, Sadra St., St. Sheikh Bahai University of Medical Sciences ... (Aj)
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nursing faculty, Baghyattallah 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
Baqiyatallah university of medical sciences
Full name of responsible person
Seyed Tayeb Moradian
Position
Faculty member
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Sheikh Bahaei St, Vanak Square, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8862 0823
Fax
Email
t-moradian@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah university of medical sciences
Full name of responsible person
Seyed Tayeb Moradian
Position
Faculty member
Other areas of specialty/work
Street address
Baghiyatallah University of medical sciences, Sheykh Bahaei street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8862 0823
Fax
Email
t-moradian@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing faculty, Baghyattallah University of Medical Sciences
Full name of responsible person
fatemeh beitollahi
Position
Master of science in critical care nursing student
Other areas of specialty/work
Street address
Baghiyatallah University of medical sciences, Sheykh Bahaei street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8862 0823
Fax
Email
afer.f56@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)