AnesthesiaBio-THRIVENCT03453294
Effect of THRIVE During Apneic Oxygenation in General Anesthesia on Biomarkers
A study testing Apnoeic oxygenation using THRIVE and Endotracheal intubation and mechanical ventilation in people with Anesthesia and Oxygen Toxicity, run by Karolinska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Oxygen Toxicity
- What is being tested?
- Apnoeic oxygenation using THRIVE and Endotracheal intubation and mechanical ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 22 Jan 2018to 1 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anesthesia, Oxygen Toxicity
- Being tested
- Apnoeic oxygenation using THRIVE, Endotracheal intubation and mechanical ventilation
- Keywords
- THRIVE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apnoeic oxygenation using THRIVEDevice
Apnoeic oxygenation using THRIVE
Endotracheal intubation and mechanical ventilationDevice
Endotracheal intubation and mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| Apnoeic oxygenation using THRIVE | Experimental | Oxygenation by apnoea oxygenation using THRIVE Receives: Device: Apnoeic oxygenation using THRIVE |
| Endotracheal intubation and mechanical ventilation | Active comparator | Ventilation and oxygenation by an endotracheal tub and mechanical ventilation Receives: Device: Endotracheal intubation and mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 2 hours after start of intervention
Secondary outcomes (5)
Biomarkers of neuronal injury
Biomarkers of neuronal injury and stress in blood such as S100 and Nuclear Serum Enolase
Measured: Up to 2 hours after start of intervention
Biomarkers of cardiac damage
Biomarkers of cardiac damage in blood such as troponin and ProBNP
Measured: Up to 2 hours after start of intervention
Biomarkers of kidney injury
Biomarkers of kidney injury in blood such as creatinine
Measured: Up to 2 hours after start of intervention
Markers of RNA damage
Markers of RNA damage in blood
Measured: Up to 2 hours after start of intervention
Inflammatory response
Biomarkers of Inflammatory response in blood such as cytokines and interleukins
Measured: Up to 2 hours after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start22 Jan 2018
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malin Jonsson Fagerlund, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453294
- Sponsor's protocol ID
- Bio-THRIVE
- Acronym
- Bio-THRIVE
- Status last verified
- Oct 2020
- First submitted
- 21 Jan 2018
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Trans Nasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) During Apneic Oxygenation in General Anesthesia on Biomarkers
- ClinicalTrials.gov ID
- NCT03453294
- Acronym / sponsor ID
- Bio-THRIVE / Bio-THRIVE
- Conditions
- Anesthesia, Oxygen Toxicity
- Keywords
- THRIVE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 5 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apnoeic oxygenation using THRIVE | Experimental | Device: Apnoeic oxygenation using THRIVEOxygenation by apnoea oxygenation using THRIVE |
| Endotracheal intubation and mechanical ventilation | Active comparator | Device: Endotracheal intubation and mechanical ventilationVentilation and oxygenation by an endotracheal tub and mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- American Society of Anaesthesiologist severity score >2
- New York Heart Association score >2
- Pacemaker or ICD.
- Body Mass Index >35
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apnoeic oxygenation using THRIVEApnoeic oxygenation using THRIVE | Device | Apnoeic oxygenation using THRIVE |
| Endotracheal intubation and mechanical ventilationEndotracheal intubation and mechanical ventilation | Device | Endotracheal intubation and mechanical ventilation |
Primary outcome
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
5 secondary outcomes
Biomarkers of neuronal injury
Time frame: Up to 2 hours after start of intervention
Biomarkers of cardiac damage
Time frame: Up to 2 hours after start of intervention
Biomarkers of kidney injury
Time frame: Up to 2 hours after start of intervention
Markers of RNA damage
Time frame: Up to 2 hours after start of intervention
Inflammatory response
Time frame: Up to 2 hours after start of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apnoeic oxygenation using THRIVE and Endotracheal intubation and mechanical ventilation in people with Anesthesia and Oxygen Toxicity, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative stress (time frame: Up to 2 hours after start of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.