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Completed

NCT Number: NCT03453294

Effect of 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.

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Key information

Conditions

Anesthesia Oxygen Toxicity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults, >18 years old.
  • Laryngeal-surgery where apnea is of benefit for the surgeon (eg. intraoral or laryngeal surgery).
  • Capable of understanding the study information and sign the written consent.

Exclusion criteria

  • American Society of Anaesthesiologist severity score >2
  • New York Heart Association score >2
  • Pacemaker or ICD.
  • Body Mass Index >35
  • Pregnancy
  • Manifest cardiac failure or coronary disease
  • Severe gastrointestinal reflux.
  • Neuromuscular disorder

Treatment and study plan

Apnoeic oxygenation using THRIVE

Device

Apnoeic oxygenation using THRIVE

Endotracheal intubation and mechanical ventilation

Device

Endotracheal intubation and mechanical ventilation

Primary outcomes

  1. Oxidative stress

    Time frame: 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 outcomes

  1. Biomarkers of neuronal injury

    Time frame: Up to 2 hours after start of intervention

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

  2. Biomarkers of cardiac damage

    Time frame: Up to 2 hours after start of intervention

    Biomarkers of cardiac damage in blood such as troponin and ProBNP

  3. Biomarkers of kidney injury

    Time frame: Up to 2 hours after start of intervention

    Biomarkers of kidney injury in blood such as creatinine

  4. Markers of RNA damage

    Time frame: Up to 2 hours after start of intervention

    Markers of RNA damage in blood

  5. Inflammatory response

    Time frame: Up to 2 hours after start of intervention

    Biomarkers of Inflammatory response in blood such as cytokines and interleukins

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

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

Acronym: Bio-THRIVE

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 5, 2018
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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