High Flow Nasal Cannula to Prevent Deoxygenation During Induction of General Anesthesia in Cesarean Section
A Prospective Randomized Study of High Flow Nasal Cannula to Prevent Deoxygenation During Induction of General Anesthesia in Cesarean Section
1 other identifier
interventional
80
1 country
1
Brief Summary
Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) using high flow oxygen therapy for preoxygenation and oxygen supplementation during apnoea has shown promising results
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 Jul 2020
Shorter than P25 for not_applicable
1 active site
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
June 17, 2020
CompletedFirst Posted
Study publicly available on registry
June 19, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedAugust 18, 2020
August 1, 2020
3 months
June 17, 2020
August 16, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
measure the time of safe apnea
The apnea time will start from the onset of cessation of breathing as evidenced by a flat line in the capnogram with the absence of chest movements
10 minutes after induction
Study Arms (2)
face mask group
PLACEBO COMPARATORPregnant females will be preoxygenated with 100% oxygen using a tight-fitting face mask at a rate of 6 L/min for 3 min with end-tidal gas monitoring.
THRIVE group
ACTIVE COMPARATORHigh-flow humidified oxygen warmed to 37°C will be delivered through nasal cannula at the rate of 30 L/ min for 30 seconds then 50 liters per minute for a further 150 seconds.
Interventions
In Group F, pregnant females will be preoxygenated with 100% oxygen using a tight-fitting face mask at a rate of 6 L/min for 3 min with end-tidal gas monitoring.
In Group H, high-flow humidified oxygen warmed to 37°C will be delivered through nasal cannula at the rate of 30 L/ min for 30 seconds then 50 liters per minute for a further 150 seconds.
Eligibility Criteria
You may qualify if:
- pregnant females
- Of American Society of Anesthesiologists (ASA) physical Status I and II
- For elective cesarean section under general anesthesia
You may not qualify if:
- with room air saturation of \<98%
- anticipated difficult airway
- anticipated obstetric risk factor or precious baby
- chronic obstructive pulmonary disease
- thyrotoxicosis
- pheochromocytoma
- hyperkalaemia
- significant cardiac illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rehab Abd Elraof Abd Elaziz
Alexandria, 000000, Egypt
Related Publications (1)
Mir F, Patel A, Iqbal R, Cecconi M, Nouraei SA. A randomised controlled trial comparing transnasal humidified rapid insufflation ventilatory exchange (THRIVE) pre-oxygenation with facemask pre-oxygenation in patients undergoing rapid sequence induction of anaesthesia. Anaesthesia. 2017 Apr;72(4):439-443. doi: 10.1111/anae.13799. Epub 2016 Dec 30.
PMID: 28035669BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rehab A. Abd Elaziz, Ass.Prof.
Alexandria University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisstant Professor of Anesthesia
Study Record Dates
First Submitted
June 17, 2020
First Posted
June 19, 2020
Study Start
July 1, 2020
Primary Completion
October 1, 2020
Study Completion
November 1, 2020
Last Updated
August 18, 2020
Record last verified: 2020-08