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CompletedNCT03453294Bio-THRIVEUpdated Oct 14, 2020

Effect of THRIVE During Apneic Oxygenation in General Anesthesia on Biomarkers

An interventional study of Apnoeic oxygenation using THRIVE and Endotracheal intubation and mechanical ventilation in Anesthesia and Oxygen Toxicity, sponsored by Karolinska University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-14.

Sponsored by Karolinska University Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Anesthesia
  • Oxygen Toxicity

Keywords

  • THRIVE
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Apnoeic oxygenation using THRIVE

    Oxygenation by apnoea oxygenation using THRIVE

    Device: 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

Interventions

  • DeviceApnoeic oxygenation using THRIVE

    Apnoeic oxygenation using THRIVE

  • DeviceEndotracheal intubation and mechanical ventilation

    Endotracheal intubation and mechanical ventilation

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to 2 hours after start of intervention

Secondary outcomes

  1. Biomarkers of neuronal injury

    Biomarkers of neuronal injury and stress in blood such as S100 and Nuclear Serum Enolase

    Time frame: Up to 2 hours after start of intervention

  2. Biomarkers of cardiac damage

    Biomarkers of cardiac damage in blood such as troponin and ProBNP

    Time frame: Up to 2 hours after start of intervention

  3. Biomarkers of kidney injury

    Biomarkers of kidney injury in blood such as creatinine

    Time frame: Up to 2 hours after start of intervention

  4. Markers of RNA damage

    Markers of RNA damage in blood

    Time frame: Up to 2 hours after start of intervention

  5. Inflammatory response

    Biomarkers of Inflammatory response in blood such as cytokines and interleukins

    Time frame: Up to 2 hours after start of intervention

06

Study locations

1 site
  • Karolinska University Hospital
    Stockholm, Sweden
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03453294
Lead sponsor
Karolinska University Hospital
Responsible party
Malin Jonsson Fagerlund (Senior Consultant, Associate Professor, Karolinska University Hospital) — Principal investigator
First posted
Mar 5, 2018
Start date
Jan 22, 2018
Primary completion
Nov 1, 2018
Completion
Nov 1, 2018
Last update
Oct 14, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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