Transnasal Humidified Rapid Insufflation Ventilatory Exchange in Morbidly Obese
Increasing Duration of Apnea Without Desaturation at Induction of Anesthesia in Morbidly Obese Patients Using "Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE)"
1 other identifier
interventional
40
1 country
1
Brief Summary
This project will investigate the duration of apnea without desaturation when using transnasal humidified rapid insufflation ventilatory exchange (THRIVE) vs. low flow nasal oxygen at anesthesia induction in obese patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2018
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
May 28, 2018
CompletedFirst Posted
Study publicly available on registry
June 8, 2018
CompletedStudy Start
First participant enrolled
July 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 22, 2020
CompletedSeptember 2, 2020
September 1, 2020
1.5 years
May 28, 2018
September 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of safe apnea
The duration until oxygen saturation drops to 95% during laryngoscopy
duration from the application of rocuronium until the oxygen saturation drops to 95% during laryngoscopy or a maximum of 15 minutes if the oxygen saturation does not drop to this level.
Secondary Outcomes (1)
blood gas analysis
every 2 minutes after rocuronium was given until 2 minutes after intubation
Study Arms (2)
Low flow Oxygen Group
ACTIVE COMPARATORlow flow passive oxygenation during laryngoscopy with 10l/min oxygen via standard nasal prongs
THRIVE Group
EXPERIMENTALhigh flow passive oxygenation during laryngoscopy with 120l/min oxygen via THRIVE system
Interventions
low flow passive oxygenation during laryngoscopy with 10l/min oxygen via standard nasal prongs
high flow passive oxygenation during laryngoscopy with 120l/min oxygen via THRIVE system
Eligibility Criteria
You may qualify if:
- Adult patients
- American Society of Anesthesiologists physical status classification class 2-3
- BMI \> 40
- elective surgery under general anesthesia
You may not qualify if:
- expected difficult airway (El Ganzouri Risk Index \> 6)
- oxygen saturation of less than 98% despite adequate preoxygenation,
- nasal obstruction
- smoker, more than 10 cigarettes per day
- chronic respiratory disease
- FEV1 (forced expiratory volume in one second) \< 70%
- elevated intracranial pressure
- unable to give informed consent
- Pregnant or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna
Vienna, 1090, Austria
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Hamp, Doctor
Department of Anaesthesia and Intensive Care Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- The monitor measuring the main outcome parameter will be in a separate room
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 28, 2018
First Posted
June 8, 2018
Study Start
July 26, 2018
Primary Completion
January 22, 2020
Study Completion
January 22, 2020
Last Updated
September 2, 2020
Record last verified: 2020-09