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Effect of THRIVE During Apneic Oxygenation in General Anesthesia on Biomarkers

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03453294
Acronym
Bio-THRIVE
Enrollment
30
Registered
2018-03-05
Start date
2018-01-22
Completion date
2018-11-01
Last updated
2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Oxygen Toxicity

Keywords

THRIVE

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.

Interventions

DEVICEApnoeic oxygenation using THRIVE

Apnoeic oxygenation using THRIVE

DEVICEEndotracheal intubation and mechanical ventilation

Endotracheal intubation and mechanical ventilation

Sponsors

Karolinska University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Oxidative stressUp to 2 hours after start of interventionBiomarkers of oxidative stress such as Thiobarbituric acid reactive substances, Advanced Oxidation Protein Products,Reactive oxygen species and total antioxidant capacity in blood samples

Secondary

MeasureTime frameDescription
Biomarkers of neuronal injuryUp to 2 hours after start of interventionBiomarkers of neuronal injury and stress in blood such as S100 and Nuclear Serum Enolase
Biomarkers of cardiac damageUp to 2 hours after start of interventionBiomarkers of cardiac damage in blood such as troponin and ProBNP
Biomarkers of kidney injuryUp to 2 hours after start of interventionBiomarkers of kidney injury in blood such as creatinine
Markers of RNA damageUp to 2 hours after start of interventionMarkers of RNA damage in blood
Inflammatory responseUp to 2 hours after start of interventionBiomarkers of Inflammatory response in blood such as cytokines and interleukins

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026