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

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Oxygen Toxicity
• Intervention / Treatment: Device: Apnoeic oxygenation using THRIVE; Device: Endotracheal intubation and mechanical ventilation

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apnoeic oxygenation using THRIVE; Oxygenation by apnoea oxygenation using THRIVE	Device: Apnoeic oxygenation using THRIVE; Apnoeic oxygenation using THRIVE
Active Comparator: Endotracheal intubation and mechanical ventilation; Ventilation and oxygenation by an endotracheal tub and mechanical ventilation	Device: Endotracheal intubation and mechanical ventilation; Endotracheal intubation and mechanical ventilation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: January 21, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: THRIVE
• Other Study ID Numbers: Bio-THRIVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No