Apneic OxygenationThriVentNCT05234424
Flow Rate Impact on Arterial Carbon Dioxide During THRIVE
A study testing THRIVE in people with Apneic Oxygenation, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
Apneic oxygenation describes the process of continuous oxygenation of the blood without breathing efforts. This anesthesia technique has been described in the literature for more than 100 years and is sometimes used under general anesthesia, e.g. during surgery of the vocal chords. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Apneic Oxygenation
- What is being tested?
- THRIVE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSweden
- Study dates
- 8 Feb 2022to 13 May 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting for elective surgery
Who cannot join
- Age <18 or >65 years
- Body Mass Index (BMI) >35 kg m-2
- American Society of Anesthesiology classification > 2
- Physical activity level less than 5 metabolic equivalents
- Obstruction of the upper airways
- Known or high clinical suspicion of difficult airway
Show all 13Show fewer
- Obstructive sleep apnea syndrome
- Increased risk of aspiration
- Pulmonary or cardiac condition resulting in a reduction of physical activity level equivalent to the New York Heart Association class of 2 or higher.
- Any contraindication to high-flow nasal oxygen therapy or hypercapnia
- Pregnancy or breastfeeding
- Allergy to any of the anesthetic agents used in the study
- Inability to comprehend oral or written information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flow Rate Impact on Arterial Carbon Dioxide Accumulation During Transnasal Humidified Rapid-insufflation Ventilation Exchange: a Randomized Cross-over Study
Apneic oxygenation describes the process of continuous oxygenation of the blood without breathing efforts. This anesthesia technique has been described in the literature for more than 100 years and is sometimes used under general anesthesia, e.g. during surgery of the vocal chords. Although this technique usually provides marked prolongation of the apneic period because of excellent oxygenation, it is limited by the absence of ventilation and the corresponding accumulation of carbon dioxide in the blood. This will lead to worsening respiratory acidosis and associated complications, such as cardiac arrythmias.
In 2015 it was reported that apneic oxygenation with high-flow nasal oxygen delivery systems (HFNO), a device that provides heated humidified oxygen at high flow rates (usually 30-70 L/min), resulted in less carbon dioxide accumulation compared with historical controls. This specific technique of apneic oxygenation was termed transnasal humidified rapid-insufflation ventilation exchange (THRIVE). To date, the impact on different flow rates on blood carbon dioxide accumulation during THRIVE is unknown. Specifically, very high flow rates, exceeding 70 L/min have not been investigated. Therefore, the aim of this trial is therefore to study the rate of accumulation of carbon dioxide during THRIVE at two different flow rates: 40 and 100 L/min.
Read the detailed description
Eligible participants with signed informed consent presenting for elective surgery will have standard monitoring with ECG, pulse oximetry, blood pressure, train-of-four monitoring and capnography applied at arrival to the operating room. In addition, a circumferential electric impedance tomography thoracic elastic band with equally spaced electrodes will be placed in the 4th to 6th intercostal space. After induction of general anesthesia with a target controlled infusion of Propofol+Remifentanil and muscle relaxation with Rocuronium bromide, adequate face mask ventilation will be confirmed and arterial cannulation will be performed.
Patients will thereafter receive THRIVE at two flow rates for 10 minutes each in a randomized order. During THRIVE, video laryngoscopy will be performed with a grade 2B visualization of the larynx to establish similar airway patency during the interventions.
Before each flow, an end-tidal oxygen value of >0.85 and end-tidal carbon dioxide value of 4.5-5.0 kPa is achieved by controlled pressure regulated volume control ventilation to establish similar arterial partial pressure of oxygen and carbon dioxide at baseline. An arterial blood gas will also be analyzed before the start of each flow rate to ensure that the initial pCO2 is less than 6.0 kPa. Furthermore, a standardized lung recruitment maneuver will be performed to establish similar baseline compliance of the respiratory system.
Termination criteria will be:
- All flow rates have been applied.
- Severe acidemia (pH<7.10), hypercapnia (pCO2>11.0) or desaturation to SpO2 less than 90% for more than 10 seconds. These termination criteria will apply only to the current flow rate being tested. The participant will be mask ventilated until baseline parameters are established and the next THRIVE flow rate according to randomization will be applied.
- Conditions
- Apneic Oxygenation
- Being tested
- THRIVE
- Keywords
- THRIVE, Apneic oxygenation, General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVEOther
During general anesthesia, apneic oxygenation with a high flow nasal oxygen system is applied for 10 minutes. Video laryngoscopy will be performed to achieve similar airway patency.
| Study group | Role | What they receive |
|---|---|---|
| THRIVE 40 L/min | Active comparator | 40 L/min with 100% oxygen for 10 minutes. Receives: Other: THRIVE |
| THRIVE 100 L/min | Experimental | 100 L/min with 100% oxygen for 10 minutes. Receives: Other: THRIVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial partial pressure of carbon dioxide (PaCO2) accumulation rate
Linear mean accumulation rate of PaCO2 during THRIVE (kPa/min)
Measured: 10 minutes
Secondary outcomes (8)
Arterial partial pressure of oxygen (PaO2)
Change of PaO2
Measured: 10 minutes
Peripheral saturation (SpO2)
Change of SpO2 and lowest SpO2
Measured: 10 minutes
End-tidal carbon dioxide fraction (EtCO2)
Change of EtCO2
Measured: 10 minutes
End-tidal oxygen fraction. (EtO2)
Change of EtO2
Measured: 10 minutes
End-expiratory lung impedance (EELI)
Change of EELI measured with electric impedance tomography
Measured: 10 minutes
Respiratory compliance
Change of dynamic and static respiratory compliance
Measured: 10 minutes
Heart rate
Change of heart rate
Measured: 10 minutes
Blood pressure
Change of systolic, diastolic and mean arterial blood pressure.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start8 Feb 2022
- Primary completion13 May 2024
- Study completion13 May 2024
Why it stopped: Futility. Inclusion and logistics of study in a clinical situation proved too difficult to continue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apneic OxygenationStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- After induction of general anesthesia, confirmation of adequate face mask ventilation, and successful arterial cannulation, participants will be assigned to THRIVE flow rates in a randomized order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Frykholm, Uppsala University Hospital
- Investigators
- Peter Frykholm, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234424
- Sponsor's protocol ID
- Frykholm2201
- Acronym
- ThriVent
- Status last verified
- May 2024
- First submitted
- 31 Jan 2022
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow Rate Impact on Arterial Carbon Dioxide Accumulation During Transnasal Humidified Rapid-insufflation Ventilation Exchange: a Randomized Cross-over Study
- ClinicalTrials.gov ID
- NCT05234424
- Acronym / sponsor ID
- ThriVent / Frykholm2201
- Conditions
- Apneic Oxygenation
- Keywords
- THRIVE, Apneic oxygenation, General anesthesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility. Inclusion and logistics of study in a clinical situation proved too difficult to continue.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 10 Feb 2022 (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.
Apneic oxygenation describes the process of continuous oxygenation of the blood without breathing efforts. This anesthesia technique has been described in the literature for more than 100 years and is sometimes used under general anesthesia, e.g. during surgery of the vocal chords. Although this technique usually provides marked prolongation of the apneic period because of excellent oxygenation, it is limited by the absence of ventilation and the corresponding accumulation of carbon dioxide in the blood. This will lead to worsening respiratory acidosis and associated complications, such as cardiac arrythmias.
In 2015 it was reported that apneic oxygenation with high-flow nasal oxygen delivery systems (HFNO), a device that provides heated humidified oxygen at high flow rates (usually 30-70 L/min), resulted in less carbon dioxide accumulation compared with historical controls. This specific technique of apneic oxygenation was termed transnasal humidified rapid-insufflation ventilation exchange (THRIVE). To date, the impact on different flow rates on blood carbon dioxide accumulation during THRIVE is unknown. Specifically, very high flow rates, exceeding 70 L/min have not been investigated. Therefore, the aim of this trial is therefore to study the rate of accumulation of carbon dioxide during THRIVE at two different flow rates: 40 and 100 L/min.
Detailed description
Eligible participants with signed informed consent presenting for elective surgery will have standard monitoring with ECG, pulse oximetry, blood pressure, train-of-four monitoring and capnography applied at arrival to the operating room. In addition, a circumferential electric impedance tomography thoracic elastic band with equally spaced electrodes will be placed in the 4th to 6th intercostal space. After induction of general anesthesia with a target controlled infusion of Propofol+Remifentanil and muscle relaxation with Rocuronium bromide, adequate face mask ventilation will be confirmed and arterial cannulation will be performed.
Patients will thereafter receive THRIVE at two flow rates for 10 minutes each in a randomized order. During THRIVE, video laryngoscopy will be performed with a grade 2B visualization of the larynx to establish similar airway patency during the interventions.
Before each flow, an end-tidal oxygen value of >0.85 and end-tidal carbon dioxide value of 4.5-5.0 kPa is achieved by controlled pressure regulated volume control ventilation to establish similar arterial partial pressure of oxygen and carbon dioxide at baseline. An arterial blood gas will also be analyzed before the start of each flow rate to ensure that the initial pCO2 is less than 6.0 kPa. Furthermore, a standardized lung recruitment maneuver will be performed to establish similar baseline compliance of the respiratory system.
Termination criteria will be:
- All flow rates have been applied.
- Severe acidemia (pH<7.10), hypercapnia (pCO2>11.0) or desaturation to SpO2 less than 90% for more than 10 seconds. These termination criteria will apply only to the current flow rate being tested. The participant will be mask ventilated until baseline parameters are established and the next THRIVE flow rate according to randomization will be applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- After induction of general anesthesia, confirmation of adequate face mask ventilation, and successful arterial cannulation, participants will be assigned to THRIVE flow rates in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| THRIVE 40 L/min | Active comparator | Other: THRIVE40 L/min with 100% oxygen for 10 minutes. |
| THRIVE 100 L/min | Experimental | Other: THRIVE100 L/min with 100% oxygen for 10 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting for elective surgery
Key exclusion criteria (13 listed)
- Age <18 or >65 years
- Body Mass Index (BMI) >35 kg m-2
- American Society of Anesthesiology classification > 2
- Physical activity level less than 5 metabolic equivalents
- Obstruction of the upper airways
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 |
|---|---|---|
| THRIVEDuring general anesthesia, apneic oxygenation with a high flow nasal oxygen system is applied for 10 minutes. Video laryngoscopy will be performed to achieve similar airway patency. | Other | THRIVE 100 L/min, THRIVE 40 L/min |
Primary outcome
Arterial partial pressure of carbon dioxide (PaCO2) accumulation rate
Time frame: 10 minutes
Linear mean accumulation rate of PaCO2 during THRIVE (kPa/min)
8 secondary outcomes
Arterial partial pressure of oxygen (PaO2)
Time frame: 10 minutes
Peripheral saturation (SpO2)
Time frame: 10 minutes
End-tidal carbon dioxide fraction (EtCO2)
Time frame: 10 minutes
End-tidal oxygen fraction. (EtO2)
Time frame: 10 minutes
End-expiratory lung impedance (EELI)
Time frame: 10 minutes
Respiratory compliance
Time frame: 10 minutes
Heart rate
Time frame: 10 minutes
Blood pressure
Time frame: 10 minutes
Results and safety
The study was stopped early (reason given: Futility. Inclusion and logistics of study in a clinical situation proved too difficult to continue.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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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.
Peter Frykholm, MD, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THRIVE in people with Apneic Oxygenation, run by Uppsala 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 1 inclusion and 13 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: stopped early, as of the sponsor's last update on 16 May 2024. 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 was stopped early (reason given: Futility. Inclusion and logistics of study in a clinical situation proved too difficult to continue.). Results are not available in the source record.
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?
Arterial partial pressure of carbon dioxide (PaCO2) accumulation rate (time frame: 10 minutes). 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 16 May 2024.