Nasal High Flow in Bariatric Surgery
Primary Purpose
Morbid Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oxygen therapy via HFNC
Oxygen therapy via face mask
Sponsored by

About this trial
This is an interventional prevention trial for Morbid Obesity focused on measuring morbid obesity, bariatric surgery, high frequency nasal cannula, oxygenation
Eligibility Criteria
Inclusion Criteria:
- Patients with a body mass index of 40-55 kg/m2
- American Society of Anesthesiologists score II-III
- Patients undergoing laparoscopic sleeve gastrectomy or one anastomosis gastric bypass
Exclusion Criteria:
- Obstructive sleep apnea syndrome
- Using a non invasive mechanical ventilation device preoperatively
- Patients whoo will predicted to postanesthesia care unit admission postoperatively
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Oxygen therapy via HFNC
Oxygen therapy via face mask
Arm Description
Patients who will be applied high frequency nasal cannula before and after surgery
Patients who will be applied O2 via face mask before and after surgery
Outcomes
Primary Outcome Measures
PO2 value
PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery
PCO2 value
PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04048798
Brief Title
Nasal High Flow in Bariatric Surgery
Official Title
Effect of Nasal High Flow on Perioperative Oxygenation in Patients Undergoing Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
High frequency nasal cannula (HFNC) provides an inspiration O2 fraction of 21-1% and it has a minimal dead space and can be well tolerated due to humidified air. Group I patients will be applied HFNC before and after bariatric surgery, Group II patients will be applied a constant O2 concentration via face mask. Oxygen pressure, oxygen saturation, carbon dioxide, respiration frequency, forced vital capacity will be measured before and after surgery.
Detailed Description
Morbid obese patients are prone to atelectasis and hypoxemia after bariatric surgery. High frequency nasal cannula (HFNC) provides an inspiration O2 fraction of 21-1% and it has a minimal dead space and can be well tolerated due to humidified air. It provides 5-7 cm H2O positive end expiratory pressure to the airways and may prevent atelectasis. In the preoperative room, forced vital capacity, peripheral oxygen saturation (SpO2), respiratory frequency, heart rate (HR), blood pressure (BP), carbon dioxide, oxygen pressure and carbon dioxide partial pressure values in blood gas analysis will be recorded. We will apply HFNC in the preoperative and postoperative period to Group I patients, while applying a constant O2 concentration to Group II patients. After appliying HFNC for two hours in Group I patients and O2 via face mask in Group II patients measurements will be repeated. During surgery, similar mechanical ventilation parameters will be applied to the patients. After the operation Group I patients will be applied HFNC, while Group II patients will be applied O2 via face mask in the recovery room for two hours. Measurements will be repeated. Primary end point of the study is the association between oxygen pressure, carbon dioxide partial pressure values among preoperative before and after HFNC and O2 and postoperative times.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
morbid obesity, bariatric surgery, high frequency nasal cannula, oxygenation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oxygen therapy via HFNC
Arm Type
Active Comparator
Arm Description
Patients who will be applied high frequency nasal cannula before and after surgery
Arm Title
Oxygen therapy via face mask
Arm Type
Active Comparator
Arm Description
Patients who will be applied O2 via face mask before and after surgery
Intervention Type
Other
Intervention Name(s)
Oxygen therapy via HFNC
Intervention Description
Oxygen treatment will be applied to the patients via HFNC before and after surgery
Intervention Type
Other
Intervention Name(s)
Oxygen therapy via face mask
Intervention Description
Oxygen treatment will be applied to the patients via face mask before and after surgery
Primary Outcome Measure Information:
Title
PO2 value
Description
PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery
Time Frame
24 hours
Title
PCO2 value
Description
PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with a body mass index of 40-55 kg/m2
American Society of Anesthesiologists score II-III
Patients undergoing laparoscopic sleeve gastrectomy or one anastomosis gastric bypass
Exclusion Criteria:
Obstructive sleep apnea syndrome
Using a non invasive mechanical ventilation device preoperatively
Patients whoo will predicted to postanesthesia care unit admission postoperatively
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cigdem A BEYOGLU
Phone
+905052278176
Email
akyolbeyoglu@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guniz Koksal
Phone
05424138505
Email
gunizkoksal@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cigdem A BEYOGLU
Organizational Affiliation
İstanbul Üniversitesi- Cerrahpaşa Cerrahpaşa Tıp Fakültesi
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
I am unaware of the advantages or disadvantages of sharing IPD
Citations:
PubMed Identifier
17635423
Citation
Baraka AS, Taha SK, Siddik-Sayyid SM, Kanazi GE, El-Khatib MF, Dagher CM, Chehade JM, Abdallah FW, Hajj RE. Supplementation of pre-oxygenation in morbidly obese patients using nasopharyngeal oxygen insufflation. Anaesthesia. 2007 Aug;62(8):769-73. doi: 10.1111/j.1365-2044.2007.05104.x.
Results Reference
background
Learn more about this trial
Nasal High Flow in Bariatric Surgery
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