Effect of THRIVE During Apneic Oxygenation in General Anesthesia on Biomarkers

Not Applicable

Completed

• Conditions: Anesthesia; Oxygen Toxicity
• Interventions: Device: Endotracheal intubation and mechanical ventilation; Device: Apnoeic oxygenation using THRIVE

• Registration Number: NCT03453294
• Lead Sponsor: Karolinska University Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-21
• Study Start: 2018-01-22
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-05
• Primary Completion: 2018-11-01
• Study Completion: 2018-11-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endotracheal intubation and mechanical ventilation	Endotracheal intubation and mechanical ventilation	Ventilation and oxygenation by an endotracheal tub and mechanical ventilation
Apnoeic oxygenation using THRIVE	Apnoeic oxygenation using THRIVE	Oxygenation by apnoea oxygenation using THRIVE

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden