Anaesthesia, GeneralNCT02706431
Oxygenation by 100% Oxygen Via High Flow Nasal Cannula in Surgical Patients
A study testing Hyperventilation in people with Anaesthesia, General and Anesthesia, Intravenous, run by Karolinska University Hospital.
Trial summary
Oxygenation with high-flow nasal cannula with 100% oxygen has only been evaluated in a limited number of studies. Although data are convincing it is of importance to evaluate this new concept in our department before implementing it into clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaesthesia, General, Anesthesia, Intravenous, Ventilation
- What is being tested?
- Hyperventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2015to 1 Sep 2016
- 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
- Adult, >18 years old
- ENT-surgery where apnea is of benefit for the surgeon (eg. intraoral or laryngeal surgery) and the anesthesia time is <40 mins.
- Capable of understanding the study information and sign the written consent.
Who cannot join
- ASA>2
- NYHA >2
- BMI >30
- Pregnancy
- Manifest cardiac failure or coronary disease
- Neuromuscular disease
About this study
Official title: Evaluation of Oxygenation by 100% Oxygen Via High Flow Nasal Cannula During Apnea in Adult Elective Surgical ENT Patients
Oxygenation with high-flow nasal cannula with 100% oxygen has only been evaluated in a limited number of studies. Although data are convincing it is of importance to evaluate this new concept in our department before implementing it into clinical practice.
The general purpose of this project is to evaluate a new ventilation strategy during ENT-surgery based on oxygenation with high-flow nasal cannula with 100% oxygen with focus on gas exchange.
- Conditions
- Anaesthesia, General, Anesthesia, Intravenous, Ventilation
- Being tested
- Hyperventilation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperventilationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Normoventilation | No intervention | The patients will be normoventilated before anesthesia |
| Hyperventilation | Experimental | Prior to anesthesia, the patients will hyperventilate during 2 mins or until symptoms from the central nervous system (e.g. dizziness). Receives: Procedure: Hyperventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in arterial carbon dioxide (pCO2)
Measured: From start of anaesthesia to end of apnoea oxygenation or max 30 minutes
Change in arterial pH
Measured: From start of anaesthesia to end of apnoea oxygenation or max 30 minutes
Change in arterial oxygen tension (pO2)
Measured: From start of anaesthesia to end of apnoea oxygenation or max 30 minutes
Secondary outcomes (4)
Does hyperventilation prior to anaesthesia and apnoea oxygenation cause any difference in pCO2 in the end of the apnea (i.e. at up to 30 minutes) compared to normoventilation?
Measured: In the end of the apnoea period, i.e. at approximately 20 minutes
Does hyperventilation prior to anaesthesia and apnoea oxygenation cause any difference in pH in the end of the apnea (i.e. at up to 30 minutes) compared to normoventilation?
Measured: In the end of the apnoea period, i.e. at approximately 20 minutes
Does hyperventilation prior to anaesthesia and apnoea oxygenation cause any difference in pO2 in the end of the apnea (i.e. at up to 30 minutes) compared to normoventilation?
Measured: In the end of the apnoea period, i.e. at approximately 20 minutes
Does the high oxygen content cause atelectasis measures as change in relation between pCO2 and end tidal carbon dioxide
Measured: Until discharge from the postoperative unit, often max 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study start1 Dec 2015
- Primary completion30 Jun 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anaesthesia, GeneralStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 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
- Investigators
- Malin Jonsson Fagerlund, MD, PhD, Principal investigator, Karolinska University Hospital and Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706431
- Sponsor's protocol ID
- Apnoic Oxygenation
- Status last verified
- Dec 2017
- First submitted
- 15 Dec 2015
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Gustafsson IM, Lodenius A, Tunelli J, Ullman J, Jonsson Fagerlund M. Apnoeic oxygenation in adults under general anaesthesia using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) - a physiological study. Br J Anaesth. 2017 Apr 1;118(4):610-617. doi: 10.1093/bja/aex036.
PubMed 28403407
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oxygenation by 100% Oxygen Via High Flow Nasal Cannula During Apnea in Adult Elective Surgical ENT Patients
- ClinicalTrials.gov ID
- NCT02706431
- Acronym / sponsor ID
- Apnoic Oxygenation
- Conditions
- Anaesthesia, General, Anesthesia, Intravenous, Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 11 Mar 2016 (estimated)
- 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 has only been evaluated in a limited number of studies. Although data are convincing it is of importance to evaluate this new concept in our department before implementing it into clinical practice.
The general purpose of this project is to evaluate a new ventilation strategy during ENT-surgery based on oxygenation with high-flow nasal cannula with 100% oxygen with focus on gas exchange.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normoventilation | No intervention | –The patients will be normoventilated before anesthesia |
| Hyperventilation | Experimental | Procedure: HyperventilationPrior to anesthesia, the patients will hyperventilate during 2 mins or until symptoms from the central nervous system (e.g. dizziness). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult, >18 years old
- ENT-surgery where apnea is of benefit for the surgeon (eg. intraoral or laryngeal surgery) and the anesthesia time is <40 mins.
- Capable of understanding the study information and sign the written consent.
Key exclusion criteria (6 listed)
- ASA>2
- NYHA >2
- BMI >30
- Pregnancy
- Manifest cardiac failure or coronary disease
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 |
|---|---|---|
| Hyperventilation | Procedure or surgery | Hyperventilation |
Primary outcome
Change in arterial carbon dioxide (pCO2)
Time frame: From start of anaesthesia to end of apnoea oxygenation or max 30 minutes
Change in arterial pH
Time frame: From start of anaesthesia to end of apnoea oxygenation or max 30 minutes
Change in arterial oxygen tension (pO2)
Time frame: From start of anaesthesia to end of apnoea oxygenation or max 30 minutes
4 secondary outcomes
Does hyperventilation prior to anaesthesia and apnoea oxygenation cause any difference in pCO2 in the end of the apnea (i.e. at up to 30 minutes) compared to normoventilation?
Time frame: In the end of the apnoea period, i.e. at approximately 20 minutes
Does hyperventilation prior to anaesthesia and apnoea oxygenation cause any difference in pH in the end of the apnea (i.e. at up to 30 minutes) compared to normoventilation?
Time frame: In the end of the apnoea period, i.e. at approximately 20 minutes
Does hyperventilation prior to anaesthesia and apnoea oxygenation cause any difference in pO2 in the end of the apnea (i.e. at up to 30 minutes) compared to normoventilation?
Time frame: In the end of the apnoea period, i.e. at approximately 20 minutes
Does the high oxygen content cause atelectasis measures as change in relation between pCO2 and end tidal carbon dioxide
Time frame: Until discharge from the postoperative unit, often max 2 hours
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 19 Dec 2017.
- Derived from this study: PubMed 28403407Gustafsson IM, Lodenius A, Tunelli J, Ullman J, Jonsson Fagerlund M. Apnoeic oxygenation in adults under general anaesthesia using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) - a physiological study. Br J Anaesth. 2017 Apr 1;118(4):610-617. doi: 10.1093/bja/aex036.
- 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.
Malin Jonsson Fagerlund, MD, PhD principal investigator
Karolinska University Hospital and Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A study testing Hyperventilation in people with Anaesthesia, General and Anesthesia, Intravenous, run by Karolinska University Hospital.
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 6 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 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in arterial carbon dioxide (pCO2) (time frame: From start of anaesthesia to end of apnoea oxygenation or max 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02706431, which also lists 1 linked publication.
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 19 Dec 2017.