Effect of THRIVE During Apneic Oxygenation in General Anesthesia on Biomarkers

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Trans Nasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) During Apneic Oxygenation in General Anesthesia on Biomarkers

Conditions
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Anesthesia, Oxygen Toxicity

Intervention / Treatment
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* Device: Apnoeic oxygenation using THRIVE
* Device: Endotracheal intubation and mechanical ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults, >18 years old. Laryngeal-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. Exclusion Criteria: American Society of Anaesthesiologist severity score >2 New York Heart Association score >2 Pacemaker or ICD. Body Mass Index >35 Pregnancy Manifest cardiac failure or coronary disease Severe gastrointestinal reflux. Neuromuscular disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apnoeic oxygenation using THRIVE<br>Oxygenation by apnoea oxygenation using THRIVE | Device: Apnoeic oxygenation using THRIVE<br>* Apnoeic oxygenation using THRIVE<br>|
| Active Comparator: Endotracheal intubation and mechanical ventilation<br>Ventilation and oxygenation by an endotracheal tub and mechanical ventilation | Device: Endotracheal intubation and mechanical ventilation<br>* Endotracheal intubation and mechanical ventilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative stress | Biomarkers of oxidative stress such as Thiobarbituric acid reactive substances, Advanced Oxidation Protein Products,Reactive oxygen species and total antioxidant capacity in blood samples | Up to 2 hours after start of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers of neuronal injury | Biomarkers of neuronal injury and stress in blood such as S100 and Nuclear Serum Enolase | Up to 2 hours after start of intervention | 
| Biomarkers of cardiac damage | Biomarkers of cardiac damage in blood such as troponin and ProBNP | Up to 2 hours after start of intervention | 
| Biomarkers of kidney injury | Biomarkers of kidney injury in blood such as creatinine | Up to 2 hours after start of intervention | 
| Markers of RNA damage | Markers of RNA damage in blood | Up to 2 hours after start of intervention | 
| Inflammatory response | Biomarkers of Inflammatory response in blood such as cytokines and interleukins | Up to 2 hours after start of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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THRIVE