Evaluation of Lung Atelectasis During Apneic Oxygenation Using THRIVE in Adults During Laryngeal Surgery.
A-THRIVE
1 other identifier
interventional
30
1 country
1
Brief Summary
Oxygenation with high-flow nasal cannula with 100% oxygen have now been evaluated in a number of studies and the data are convincing. The THRIVE technique is able to oxygenate patients safely and vital parameters has been shown to be stable. But it is of great importance to evaluate this new concept regarding other potential negative physiological aspects such as lung atelectasis and inflammatory stress response before implementing it into clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2018
Typical duration 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
January 21, 2018
CompletedStudy Start
First participant enrolled
January 22, 2018
CompletedFirst Posted
Study publicly available on registry
March 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2020
CompletedOctober 14, 2020
October 1, 2020
2.7 years
January 21, 2018
October 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Electrical impedans tomography
Changes in lung volumes
baseline, intraoperative, 2 hours after start of intervention
Secondary Outcomes (2)
Difference in Endtidal and arterial carbon dioxide partial pressure in the end of the procedure
max 30 minutes after start of intervention
Increase in arterial carbon dioxide during the apnea
max 30 minutes after start of intervention
Study Arms (2)
Intubation
ACTIVE COMPARATORThe patients will be intubated and ventilated
THRIVE
EXPERIMENTALThe patients will be oxygenated during apnea using THRIVE
Interventions
Ventilation during the procedure is governed by an endotracheal tube in the trachea and mechanical ventilation
Eligibility Criteria
You may qualify if:
- Adults, \>18 years old.
- ENT-surgery where apnea is of benefit for the surgeon (eg. intraoral or laryngeal surgery).
- Capable of understanding the study information and sign the written consent.
You may not qualify if:
- ASA\>2
- NYHA \>2
- Pacemaker or ICD.
- BMI \>35
- Pregnancy
- Manifest cardiac failure or coronary disease
- Severe gastrointestinal reflux.
- Neuromuscular disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska University Hospital
Stockholm, Sweden
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Malin Jonsson Fagerlund
Karolinska University Hospital and Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Consultant, Associate Professor
Study Record Dates
First Submitted
January 21, 2018
First Posted
March 8, 2018
Study Start
January 22, 2018
Primary Completion
October 10, 2020
Study Completion
October 10, 2020
Last Updated
October 14, 2020
Record last verified: 2020-10