Nasal High Flow in Bariatric Surgery
Effect of Nasal High Flow on Perioperative Oxygenation in Patients Undergoing Bariatric Surgery
1 other identifier
interventional
112
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2019
CompletedFirst Posted
Study publicly available on registry
August 7, 2019
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedAugust 7, 2019
August 1, 2019
1 year
August 2, 2019
August 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
PO2 value
PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery
24 hours
PCO2 value
PO2 value will be measured before HFNC or face mask, after HFNC or face mask and after surgery
24 hours
Study Arms (2)
Oxygen therapy via HFNC
ACTIVE COMPARATORPatients who will be applied high frequency nasal cannula before and after surgery
Oxygen therapy via face mask
ACTIVE COMPARATORPatients who will be applied O2 via face mask before and after surgery
Interventions
Oxygen treatment will be applied to the patients via HFNC before and after surgery
Oxygen treatment will be applied to the patients via face mask before and after surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Obstructive sleep apnea syndrome
- Using a non invasive mechanical ventilation device preoperatively
- Patients whoo will predicted to postanesthesia care unit admission postoperatively
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 17635423BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cigdem A BEYOGLU
İstanbul Üniversitesi- Cerrahpaşa Cerrahpaşa Tıp Fakültesi
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 2, 2019
First Posted
August 7, 2019
Study Start
January 1, 2020
Primary Completion
January 1, 2021
Study Completion
February 1, 2021
Last Updated
August 7, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share
I am unaware of the advantages or disadvantages of sharing IPD