Comparison the effect of oxygen therapy with face mask and nasal cannula on blood oxygen saturation, nausea, vomiting and patient comfort in patients undergoing spinal anesthesia during Caesarean section at Shohada hospital in Gonbad
The purpose of the randomized clinical trial study is comparing the effectiveness of two methods of oxygen therapy with face mask and nasal cannula on oxygen saturation of arterial blood, nausea, vomiting and patient comfort during surgery in patients undergoing cesarean section via spinal anesthesia at Shohada hospital in Gonbad in 2014. This study was designed in two groups. Convenience sampling will be used and 25 patients will be allocated randomly in treatment groups with face mask or nasal cannula group. Patients in group of face mask receive oxygen 8 liters per minute and in nasal cannula group receive 4 liters per minute of oxygen in two steps, immediately after spinal anesthesia and postoperative get to the recovery unit. Then arterial blood oxygen saturation, nausea and vomiting and patient comfort during surgery and in the recovery unit will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014080218649N1
Registration date:2015-04-14, 1394/01/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-14, 1394/01/25
Registrant information
Name
Khadijeh Yazdi
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 6900
Email address
yazdi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Sciences, Deputy of Research and Technology
Expected recruitment start date
2014-08-06, 1393/05/15
Expected recruitment end date
2014-11-21, 1393/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of oxygen therapy with face mask and nasal cannula on blood oxygen saturation, nausea, vomiting and patient comfort in patients undergoing spinal anesthesia during Caesarean section at Shohada hospital in Gonbad
Public title
Comparison of two methods of oxygen therapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients undergoing spinal anesthesia for elective cesarean section, first Class of American Society of Anesthesiologists, aged from 18 to 35 years, ability to communicate verbally, body mass index in the normal range, lake of breathing problems, lack of history of gastrointestinal disease, having no risk of pregnancy, absence of any nausea and vomiting 24 hours before cesarean, not receiving preoperative intravenous narcotic, preoperative SPO2 more than 95% and Hemoglobin more than 11.
Exclusion criteria: Alteration in spinal anesthesia to general anesthesia, patient's unwillingness to continue participation in the study, need for any additional surgery other than cesarean section for patients and prolonged bleeding during operation.
Age
From 18 years old to 35 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The samples will be selected by through convenience method and then they will be allocated in two groups using table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
O89.5 Other complications of spinal and epidural anaesthesia during the puerperium
Primary outcomes
1
Description
Arterial Oxygen Saturation
Timepoint
At 5 minutes intervals during surgery and in the recovery unit
Method of measurement
Pulse oximetry for oxygen saturation
Secondary outcomes
1
Description
Nausea,Vomiting and Patient Comfort
Timepoint
At 5 minutes intervals during surgery and in the recovery unit
Method of measurement
Visual scale for nausea, vomiting and patient comfort
Intervention groups
1
Description
Patients in this group will receive oxygen 8 liters per minute via face mask in two steps: immediately after administration of spinal anesthesia and at postoperative recovery unit. During the entire operation and up to 30 minutes after in the recovery unit oxygen saturation will be measured via pulse oximetry. Nausea, vomiting and patient comfort will be measured also.
Category
Other
2
Description
Patients in this group will receive oxygen 4 liters per minute via nasal cannula in two steps: immediately after administration of spinal anesthesia and postoperative recovery unit. During the entire operation and up to 30 minutes after in the recovery unit oxygen saturation will be measured via pulse oximetry. Nausea, vomiting and patient comfort will be measured also.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Ainaz Kor, Student in Master of Science in Critical Care Nursing
Street address
South Imam Khomeini Street, Gonbad
City
Gonbad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of Medical Sciences, Deputy of Research and Technology