Determination of the effect of oxygen therapy with nasal catheter and ventricular mask, after removing the tracheal tube, on the saturation of hemoglobin saturated with oxygen and arterial blood gas in patients undergoing coronary artery bypass graft surgery
Design
Randomized random sampling from patients with inclusion criteria was performed using random allocation software. After selecting the study samples, they were assigned to two groups using the random allocation software. The number of samples was considered to be 120 patients in two groups of mask and nasal catheter.
Settings and conduct
Performing oxygen therapy with nasal catheter and mask for half an hour after removing the tracheal tube and recording vital signs and data on arterial blood gases in patients who had entered the study, who performed in the intensive care unit of the heart of Afshar, Yazd Became.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Having ages 40 to 70 years, patients undergoing coronary artery bypass graft surgery, facial skin and ear and nose, and absence of chronic obstructive pulmonary disease, Ejection Fraction > 40% before surgery
Exit criteria
Lack of successful weaning, lack of self-breathing after Extract the tracheal tube, abnormal level of consciousness (Glasgow Coma Scale <15), Instability of the patient's vital signs (more than 500 cc discharge in 6 hours on the first day)
Intervention groups
mask group and nose catheter group
Main outcome variables
Oxygen therapy, arterial blood gases and vital signs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170701034831N2
Registration date:2018-09-03, 1397/06/12
Registration timing:registered_while_recruiting
Last update:2018-09-03, 1397/06/12
Update count:0
Registration date
2018-09-03, 1397/06/12
Registrant information
Name
Hamide Setoodenia karani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 1751
Email address
h.setoodenia@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences Yazd
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oxygen therapy with nasal cannula and Venturi mask on SPO2 and arterial blood gases after extubation in patients undergoing CABG
Public title
The effect of oxygen therapy with nasal cannula and Venturi mask on arterial blood gases
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40 to 70 years
Patients undergoing coronary artery bypass graft surgery
Healthy facial skin and ears and nose
Lack of chronic obstructive pulmonary disease
Ejection Fraction > 40% before surgery
Exclusion criteria:
Unsuccessful weaning of ventilator device
Not having spontaneous breath after removing the tube trachea
Glasgow Coma Scale < 15
Vital Signs unstable
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized random sampling from patients with inclusion criteria was performed using random allocation software. After selecting the study samples, they were assigned to two groups using the random allocation software.
Blinding (investigator's opinion)
Single blinded
Blinding description
The trained nurse responsible for collecting samples is due to the same type of care in relation to all patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Immediately before and after caffeine and time after intercourse
Method of measurement
Arterial blood sample, monitoring of vital signs, vas
Secondary outcomes
empty
Intervention groups
1
Description
Oxygen therapy by two methods of nasal cannula and Vancouver massage at a rate of six liters per minute for half an hour after extubation of the trachea
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar haspital
Full name of responsible person
Hamide Setoodenia Karani
Street address
Faculty of Nursing., Infertility Research Center., Bouali Ave., timsar Fallah Avenue., Safaiyeh
City
Yazd
Province
Yazd
Postal code
8917182995
Phone
+98 35 3824 1751
Fax
+98 35 3824 9705
Email
hamide.setoodenia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hamide setoodenia
Street address
Sadoughi Boulevard., Bahonar Square
City
yazd
Province
Yazd
Postal code
8917182995
Phone
+98 35 3824 1751
Fax
+98 35 3824 9705
Email
hamide.setoodenia@gmail.cim
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Hamide Setoodenia Karani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Infertility Research Center., Timsar Fallahi Avenue., Bouali Ave., Safaye
City
Yazd
Province
Yazd
Postal code
8917182995
Phone
+98 35 3824 1751
Fax
+98 35 3824 9705
Email
Hamide.setoodenia@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hamide Setoodenia karani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Infertility Research Center., Timsar Fallahi Avenue., Bouali Ave., Safaye
City
Yazd
Province
Yazd
Postal code
8917182995
Phone
+98 35 3824 1751
Fax
+98 35 3824 9705
Email
hamide.setoodenia@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hamide Setoodenia Karani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Infertility Research Center., Timsar Fallahi Avenue., Bouali Ave., Safaye
City
Yazd
Province
Yazd
Postal code
8917182995
Phone
+98 35 3824 1751
Fax
+98 35 3824 9705
Email
hamide.setoodenia@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available