NCT03453294

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

January 22, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

9 months

First QC Date

January 21, 2018

Last Update Submit

October 13, 2020

Conditions

AnesthesiaOxygen Toxicity

Keywords

THRIVE

Outcome Measures

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

    Up to 2 hours after start of intervention

Secondary Outcomes (5)

  • Biomarkers of neuronal injury

    Up to 2 hours after start of intervention

  • Biomarkers of cardiac damage

    Up to 2 hours after start of intervention

  • Biomarkers of kidney injury

    Up to 2 hours after start of intervention

  • Markers of RNA damage

    Up to 2 hours after start of intervention

  • Inflammatory response

    Up to 2 hours after start of intervention

Study Arms (2)

Apnoeic oxygenation using THRIVE

EXPERIMENTAL

Oxygenation by apnoea oxygenation using THRIVE

Device: Apnoeic oxygenation using THRIVE

Endotracheal intubation and mechanical ventilation

ACTIVE COMPARATOR

Ventilation and oxygenation by an endotracheal tub and mechanical ventilation

Device: Endotracheal intubation and mechanical ventilation

Interventions

Apnoeic oxygenation using THRIVEDEVICE

Apnoeic oxygenation using THRIVE

Apnoeic oxygenation using THRIVE
Endotracheal intubation and mechanical ventilationDEVICE

Endotracheal intubation and mechanical ventilation

Endotracheal intubation and mechanical ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

Location

MeSH Terms

Interventions

Intubation, IntratrachealRespiration, Artificial

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative TechniquesResuscitationEmergency TreatmentRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant, Associate Professor

Study Record Dates

First Submitted

January 21, 2018

First Posted

March 5, 2018

Study Start

January 22, 2018

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations

SE(1)