Effect of THRIVE During Apneic Oxygenation in General Anesthesia on Biomarkers

Anesthesia Clinical Trial

— Bio-THRIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03453294
• Other study ID #: Bio-THRIVE
• Status: Completed
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: October 2020
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Oxygen Toxicity

Intervention

Device:
• Apnoeic oxygenation using THRIVE
Apnoeic oxygenation using THRIVE
• Endotracheal intubation and mechanical ventilation
Endotracheal intubation and mechanical ventilation

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Biomarkers of cardiac damage	Biomarkers of cardiac damage in blood such as troponin and ProBNP	Up to 2 hours after start of intervention
Secondary	Biomarkers of kidney injury	Biomarkers of kidney injury in blood such as creatinine	Up to 2 hours after start of intervention
Secondary	Markers of RNA damage	Markers of RNA damage in blood	Up to 2 hours after start of intervention
Secondary	Inflammatory response	Biomarkers of Inflammatory response in blood such as cytokines and interleukins	Up to 2 hours after start of intervention