THRIVE Apneic Ventilation With Standardized Airway Management During General Anesthesia.
Apneic Oxygenation With Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) With Standardized Airway Management During General Anesthesia - an Observational Study of Blood Gas Dynamics of PaCO2, pH and PaO2.
1 other identifier
observational
36
1 country
2
Brief Summary
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) denotes the use of high-flow humidified nasal oxygen system (for example Optiflow®) as an alternative ventilation modality for an anesthetized patient without spontaneous respiration. This method requires only basic airway management manoeuvres to keep the airway open and provides both stable longterm oxygenation as well as apneic ventialtion. We plan to evaluate this methods physiological performance under standardized conditions of airway management by frequent, repeated arterial blood gas analyses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2019
Shorter than P25 for all trials
2 active sites
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
January 7, 2019
CompletedStudy Start
First participant enrolled
January 8, 2019
CompletedFirst Posted
Study publicly available on registry
January 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedJanuary 23, 2019
January 1, 2019
4 months
January 7, 2019
January 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Respiratory acidosis
Development of respiratory acidosis (pH \< 7.15 or paCO2 \> 12) over time on study
Max. 60 minutes
Interventions
Ventilation by THRIVE
Eligibility Criteria
Patients presenting for non-laryngeal surgery in general anesthesia, where intubation is not mandatory.
You may qualify if:
- Adult (age over 18 years)
- Elective surgery where intubation is not mandatory
- The patient can understand the information about the study and give their informed written consent of participation
You may not qualify if:
- ASA (American Society of Anaesthesiologists class) \> 3
- NYHA (New York Heart Association class) \> 2
- BMI \> 30 kg/m2
- Symptomatic respiratory disease
- Symptomatic cardiac disease
- Evidence of arteriosclerotic disease
- Neuromuscular disease
- Pregnancy
- Presumed or predicted difficult airway (SARI - Simplified Airway Risk Index score \> 4)
- Known or suspected nasal congestion/stenosis or catharalia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Rigshospitalet
Copenhagen, Hoevdstaden, 2100, Denmark
Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071
Copenhagen, 2100, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael S Kristensen, MD
Senior consultant, Rigshospitalet
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- SENIOR CONSULTANT
Study Record Dates
First Submitted
January 7, 2019
First Posted
January 9, 2019
Study Start
January 8, 2019
Primary Completion
May 1, 2019
Study Completion
June 1, 2019
Last Updated
January 23, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share