ApneaNCT03812354
THRIVE in Children at Different Flow Rates
A study testing THRIVE 4L/kg/min and THRIVE 2L/kg/min in people with Apnea and Ventilation Therapy; Complications, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial summary
This study investigates under controlled circumstances the concept of THRIVE to improve the ventilation and the carbon dioxide elimination, to prolong the apnoea time without deoxygenation and to improve safety of airway management in pediatric patients. Read more about this study
- Who is it for?
- Ages 1 year to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Apnea, Ventilation Therapy; Complications
- What is being tested?
- THRIVE 4L/kg/min and THRIVE 2L/kg/min
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 15 Jan 2019to 31 Mar 2020
- 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 1 year to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- paediatric patients undergoing elective surgery requiring general anesthesia with intubation at the University Hospital - Inselspital in Bern.
- ASA physical status 1\&2
- 10-15kg
- legal guardians providing written informed consent.
Who cannot join
- known or suspected difficult intubation
- oxygen dependency
- congenital heart or lung disease
- obesity BMI>20kg/m2
- high aspiration risk (requiring rapid sequence induction intubation).
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Inselspital
Bern, 3010
University Hospital Bern
Bern, 3010
About this study
Official title: THRIVE (Transnasal Humidified Rapid Insufflation Ventilatory Exchange) in Children at Different Flow Rates
This study investigates under controlled circumstances the concept of THRIVE to improve the ventilation and the carbon dioxide elimination, to prolong the apnoea time without deoxygenation and to improve safety of airway management in pediatric patients.
Read the detailed description
Eligible, consented children will be prepared for general anaesthesia in the usual way. After start of anesthesia (="induction"), adequate face-mask ventilation will be established. The sealed envelope for randomisation will then be opened. Standard anesthesia will be continued, either using sevoflurane or propofol (anesthesia depth controlled by Narcotrend, to measure anesthesia depth using processed EEG waves). They will receive additional non-invasive monitoring for this study, such as transcutaneous measurement of tcCO2 and O2, NIRS, and thoracic electrical impedance tomography (EIT, PulmoVista® 500, Draeger, Luebeck, Germany) All patients will receive neuromuscular blockade medication of 2 x ED95 (standard intubation dose) to facilitate airway management and total intravenous anesthesia will be installed (continuous application of i.v. anesthesia medication). Up to two minutes of bag-mask ventilation with 100% oxygen and flow rates of 6-8L/min will be applied until an expired oxygen concentration of >90% is reached, as well as an SpO2 of 100% and an transcutaneous CO2 of 30-40mmHg.
For the study intervention, the bag-mask ventilation will be discontinued, and the child will be left apnoeic (the same happens always during intubation) until the saturation drops to 95%, which is still a low normal value. According randomization, any of the two study intervention s will be applied (THRIVE therapy with 100% O2 2l/kg/min, THRIVE therapy with 100% O2 4l/kg/min, all via nasal cannulas) while simultaneously guaranteeing an open airway by using Esmarch's procedure (jaw thrust) and an oral airway (Guedel tube). ECG, pulse-oximetry, blood pressure, Narcotrend, NIRS, thoracic EIT, PtcO2, PtcCO2 will be measured continuously over the study period. The time until desaturation from SpO2 100% to SpO2 95% will be also measured. A chest ultrasound at the end of the intervention will prove that no pneumothorax developed during the procedure. The study intervention will end at the time the saturation reaches SpO2 95% or when any other break-up criteria are reached. Bag mask ventilation will then be re-applied until SpO2 reaches again 100% and the patient will be treated according to the attending anaesthesiologist to ultimately establish a patent airway. Break-up criteria during apnoea are: SpO2 below 95%, transcutaneous CO2 above 70 mmHg, or time of apnoea >10 minutes. Drop of NIRS > 30% from baseline. A postmedication interview will be performed before PACU discharge.
- Conditions
- Apnea, Ventilation Therapy; Complications
- Being tested
- THRIVE 4L/kg/min, THRIVE 2L/kg/min
- Keywords
- infant, airway management, apneic oxygenation
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVE 4L/kg/minOther
Also called Optiflow
High-flow nasal cannula therapy with 4L/kg/min with 100% oxygen via OptiFlow by Fisher\&Paykel, Auckland, New Zealand.
THRIVE 2L/kg/minOther
Also called Optifloe
High-flow nasal cannula therapy with 2L/kg/min with 100% oxygen via OptiFlow by Fisher\&Paykel, Auckland, New Zealand.
| Study group | Role | What they receive |
|---|---|---|
| THRIVE 2L/kg/min using OptiFlow | Active comparator | High-flow nasal cannula therapy with 2L/kg/min with 100% oxygen via OptiFlow by Fisher\&Paykel, Auckland, New Zealand. Receives: Other: THRIVE 2L/kg/min |
| THRIVE 4L/kg/min using OptiFlow | Experimental | After apnea sets in and mask ventilation is successfully established, randomization envelopes are opened and according to group allocation, the following oxygen delivery system is applied.
High-flow nasal cannula therapy with 4L/kg/min with 100% oxygen via OptiFlow by Fisher\&Paykel, Auckland, New Zealand. Receives: Other: THRIVE 4L/kg/min |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of tcCO2 in mmHg/min
mean tcCO2 increase in mmHg/min during apnoea time, measured transcutaneously.
Measured: 10 minutes
Secondary outcomes (4)
desaturation from SpO2 100% to 95%
time (in seconds) until desaturation from SpO2 100% to 95%
Measured: 10 minutes
tcO2 in mmHg/min
Changes in tcO2 in mmHg/min
Measured: 10 minutes
NIRS
changes in brain oxygenation (measured by near infrared spectroscopy (NIRS)) during apnoea time
Measured: 10 minutes
Electrical impedance tomography
changes in electrical impedance tomography (EIT) to validate ventilatory effect
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 posted23 Jan 2019
- Study start15 Jan 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
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 ApneaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Riva, Insel Gruppe AG, University Hospital Bern
- Investigators
- Robert Greif, MD, Study chair, Department of Anesthesia, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812354
- Sponsor's protocol ID
- Riva2018
- Status last verified
- Aug 2020
- First submitted
- 18 Jan 2019
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Riva T, Preel N, Theiler L, Greif R, Butikofer L, Ulmer F, Seiler S, Nabecker S. Evaluating the ventilatory effect of transnasal humidified rapid insufflation ventilatory exchange in apnoeic small children with two different oxygen flow rates: a randomised controlled trial. Anaesthesia. 2021 Jul;76(7):924-932. doi: 10.1111/anae.15335. Epub 2020 Dec 22.
PubMed 33351194
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THRIVE (Transnasal Humidified Rapid Insufflation Ventilatory Exchange) in Children at Different Flow Rates
- ClinicalTrials.gov ID
- NCT03812354
- Acronym / sponsor ID
- Riva2018
- Conditions
- Apnea, Ventilation Therapy; Complications
- Keywords
- infant, airway management, apneic oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 23 Jan 2019 (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.
This study investigates under controlled circumstances the concept of THRIVE to improve the ventilation and the carbon dioxide elimination, to prolong the apnoea time without deoxygenation and to improve safety of airway management in pediatric patients.
Detailed description
Eligible, consented children will be prepared for general anaesthesia in the usual way. After start of anesthesia (="induction"), adequate face-mask ventilation will be established. The sealed envelope for randomisation will then be opened. Standard anesthesia will be continued, either using sevoflurane or propofol (anesthesia depth controlled by Narcotrend, to measure anesthesia depth using processed EEG waves). They will receive additional non-invasive monitoring for this study, such as transcutaneous measurement of tcCO2 and O2, NIRS, and thoracic electrical impedance tomography (EIT, PulmoVista® 500, Draeger, Luebeck, Germany) All patients will receive neuromuscular blockade medication of 2 x ED95 (standard intubation dose) to facilitate airway management and total intravenous anesthesia will be installed (continuous application of i.v. anesthesia medication). Up to two minutes of bag-mask ventilation with 100% oxygen and flow rates of 6-8L/min will be applied until an expired oxygen concentration of >90% is reached, as well as an SpO2 of 100% and an transcutaneous CO2 of 30-40mmHg.
For the study intervention, the bag-mask ventilation will be discontinued, and the child will be left apnoeic (the same happens always during intubation) until the saturation drops to 95%, which is still a low normal value. According randomization, any of the two study intervention s will be applied (THRIVE therapy with 100% O2 2l/kg/min, THRIVE therapy with 100% O2 4l/kg/min, all via nasal cannulas) while simultaneously guaranteeing an open airway by using Esmarch's procedure (jaw thrust) and an oral airway (Guedel tube). ECG, pulse-oximetry, blood pressure, Narcotrend, NIRS, thoracic EIT, PtcO2, PtcCO2 will be measured continuously over the study period. The time until desaturation from SpO2 100% to SpO2 95% will be also measured. A chest ultrasound at the end of the intervention will prove that no pneumothorax developed during the procedure. The study intervention will end at the time the saturation reaches SpO2 95% or when any other break-up criteria are reached. Bag mask ventilation will then be re-applied until SpO2 reaches again 100% and the patient will be treated according to the attending anaesthesiologist to ultimately establish a patent airway. Break-up criteria during apnoea are: SpO2 below 95%, transcutaneous CO2 above 70 mmHg, or time of apnoea >10 minutes. Drop of NIRS > 30% from baseline. A postmedication interview will be performed before PACU discharge.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THRIVE 2L/kg/min using OptiFlow | Active comparator | Other: THRIVE 2L/kg/minHigh-flow nasal cannula therapy with 2L/kg/min with 100% oxygen via OptiFlow by Fisher\&Paykel, Auckland, New Zealand. |
| THRIVE 4L/kg/min using OptiFlow | Experimental | Other: THRIVE 4L/kg/minAfter apnea sets in and mask ventilation is successfully established, randomization envelopes are opened and according to group allocation, the following oxygen delivery system is applied. High-flow nasal cannula therapy with 4L/kg/min with 100% oxygen via OptiFlow by Fisher\&Paykel, Auckland, New Zealand. |
Who may qualify
- Ages
- 1 year to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- paediatric patients undergoing elective surgery requiring general anesthesia with intubation at the University Hospital - Inselspital in Bern.
- ASA physical status 1\&2
- 10-15kg
- legal guardians providing written informed consent.
Key exclusion criteria (5 listed)
- known or suspected difficult intubation
- oxygen dependency
- congenital heart or lung disease
- obesity BMI>20kg/m2
- high aspiration risk (requiring rapid sequence induction intubation).
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 |
|---|---|---|
| THRIVE 4L/kg/minAlso: OptiflowHigh-flow nasal cannula therapy with 4L/kg/min with 100% oxygen via OptiFlow by Fisher\&Paykel, Auckland, New Zealand. | Other | THRIVE 4L/kg/min using OptiFlow |
| THRIVE 2L/kg/minAlso: OptifloeHigh-flow nasal cannula therapy with 2L/kg/min with 100% oxygen via OptiFlow by Fisher\&Paykel, Auckland, New Zealand. | Other | THRIVE 2L/kg/min using OptiFlow |
Primary outcome
Change of tcCO2 in mmHg/min
Time frame: 10 minutes
mean tcCO2 increase in mmHg/min during apnoea time, measured transcutaneously.
4 secondary outcomes
desaturation from SpO2 100% to 95%
Time frame: 10 minutes
tcO2 in mmHg/min
Time frame: 10 minutes
NIRS
Time frame: 10 minutes
Electrical impedance tomography
Time frame: 10 minutes
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 7 Aug 2020.
- Derived from this study: PubMed 33351194Riva T, Preel N, Theiler L, Greif R, Butikofer L, Ulmer F, Seiler S, Nabecker S. Evaluating the ventilatory effect of transnasal humidified rapid insufflation ventilatory exchange in apnoeic small children with two different oxygen flow rates: a randomised controlled trial. Anaesthesia. 2021 Jul;76(7):924-932. doi: 10.1111/anae.15335. Epub 2020 Dec 22.
- 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.
Robert Greif, MD study chair
Department of Anesthesia, University Hospital Bern
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THRIVE 4L/kg/min and THRIVE 2L/kg/min in people with Apnea and Ventilation Therapy; Complications, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
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 4 inclusion and 5 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 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Change of tcCO2 in mmHg/min (time frame: 10 minutes). 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 NCT03812354, 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 7 Aug 2020.