Nasal Flow High Oxygen Therapy Effect on Respiratory Quality in Patient Care Units after Surgery
Design
Clinical trial with CPAP, HFNT, with parallel groups, blind, randomized,
Settings and conduct
Patients undergoing laparoscopic slashing gastrectomy surgery referring to Shahid Modarres Hospital are divided into two groups. The cpap group, after which the patients undergo emergency recovery at the CPAP with a mask (CmH2O) of 8-12, and the HFNT group that the patients after Extubation in recovery is immediately superimposed on oxygen therapy through HIGH FLOW NASAL (OPTIFLOW) with FIO2: 50% and FLOW45-55 L / MIN.
Participants/Inclusion and exclusion criteria
Entry: Includes people between 18 and 65 years of age BMI> 35 Obesity in the last 3 years without hormone problems and STOP BANG> 3 (16)
Exit: Includes nasal defect, such as nasal polyps, septal perforation (acute or chronic pulmonary disease, an episode hemorrhage that requires transfusion).
Intervention groups
Group CPAP: After recovery, patients are immediately exposed to CPAP mask (CmH2O) 8-12. And in the ICU, the surgery lasts for at least 8 hours.
HFNT group: Patients after recovery in recovery are immediately put on oxygen therapy through HIGH FLOW NASAL (OPTIFLOW) with FIO2: 50% and FLOW45-55 L / MIN. And at ECU surgery is continued for at least 8 hours
Main outcome variables
PaCO2;PaO2;PEFR;AHI;(m-RAS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150107020592N21
Registration date:2019-06-23, 1398/04/02
Registration timing:registered_while_recruiting
Last update:2019-06-23, 1398/04/02
Update count:0
Registration date
2019-06-23, 1398/04/02
Registrant information
Name
Seyed Mohammad Reza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9944
Email address
iran.criticalcare@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-18, 1397/12/27
Expected recruitment end date
2020-03-17, 1398/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Nasal High-Flow oxygen therapy on respiratory performance in ICU after bariatric surgery
Public title
Effect of Nasal High-Flow oxygen therapy on respiratory performance in ICU after bariatric surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People between 18 and 65 years old
BMI>35
The presence of obesity in the last 3 years without hormonal problems
STOP BANG>3
Exclusion criteria:
Nasal defects such as nasal polyps, septum perforation
Acute or Chronic Pulmonary Patient
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization of the two groups is based on the even and the odd numbers, the even numbers belong to the intervention group and The odd numbers belong to patients in the control group..
Blinding (investigator's opinion)
Double blinded
Blinding description
Laboratory, clinical and radiological evidence is collected by people who do not have the type of intervention.The analysis is done by someone else who does not have the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences and Health Services
Patients undergoing laparoscopic surgery for gastrectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
PCO2
Timepoint
Every eight hours for a day
Method of measurement
Using ABG
2
Description
PO2
Timepoint
Every eight hours for a day
Method of measurement
Using ABG
3
Description
PEAK expiratory flow rate
Timepoint
After surgery, bariatric
Method of measurement
peak flow meter
4
Description
Apnea–Hypopnea Index
Timepoint
After surgery, bariatric
Method of measurement
Poly Somnography
5
Description
modified radiological atelectasis score
Timepoint
After surgery, bariatric
Method of measurement
نمرات CXR
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: After recovery, the patients are immediately treated with CPAP mask (CmH2O) 8-12 and surgical ICU is continued for at least 8 hours.
Category
Treatment - Other
2
Description
Second intervention group: After recovery, the patients immediately receive oxygen therapy through HIGH FLOW NASAL (OPTIFLOW) with FIO2: 50% and FLOW45-55 L / MIN, and they continue to undergo surgery for at least 8 hours.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarress Educational Hospital
Full name of responsible person
navid nooraei
Street address
Saadat Abad St.Yadegare Imam Highway,Tehran
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Fax
+98 21 2207 4101
Email
modarres@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences