Effect of THRIVE During Apneic Oxygenation in General Anesthesia on Biomarkers (Bio-THRIVE)

Karolinska University Hospital

Status: Completed

Conditions: Oxygen Toxicity; Anesthesia

Treatments: Device: Endotracheal intubation and mechanical ventilation; Device: Apnoeic oxygenation using THRIVE

Study type: Interventional

Funder types: Other

Identifiers

NCT03453294

Bio-THRIVE

Details and patient eligibility

About

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 biological stress response detected by blood-bourne biomarkers before implementing it into clinical practice.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults, >18 years old.
2. Laryngeal-surgery where apnea is of benefit for the surgeon (eg. intraoral or laryngeal surgery).
3. Capable of understanding the study information and sign the written consent.

Exclusion criteria

1. American Society of Anaesthesiologist severity score >2
2. New York Heart Association score >2
3. Pacemaker or ICD.
4. Body Mass Index >35
5. Pregnancy
6. Manifest cardiac failure or coronary disease
7. Severe gastrointestinal reflux.
8. Neuromuscular disorder

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Apnoeic oxygenation using THRIVE

Experimental group

Description:

Oxygenation by apnoea oxygenation using THRIVE

Treatment:

Device: Apnoeic oxygenation using THRIVE

Endotracheal intubation and mechanical ventilation

Active Comparator group

Description:

Ventilation and oxygenation by an endotracheal tub and mechanical ventilation

Treatment:

Device: Endotracheal intubation and mechanical ventilation