Preoxygenationi-ThriveNCT02979067
Improvement of Oxygenation During Apnoea by i-THRIVE
A study testing Nasal oxygen flow in people with Preoxygenation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Improvement of oxygenation during apnoea by i-THRIVE Infant Transnasal Humidified Rapid Insufflation Ventilatory Exchange A single-centre prospective randomized controlled trial. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preoxygenation
- What is being tested?
- Nasal oxygen flow
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2016to May 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 10-20 kg
- ASA 1+2
- Written informed consent
- Speaking German
Who cannot join
- Difficult intubation
- Oxygen dependency
- Congenital heart or lung disease
- BMI >30g/m2
- High aspiration risk
- nasal obstruction
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Bern University Hospital and University of Bern
Bern, 3011
About this study
Official title: Improvement of Oxygenation During Apnoea by i-THRIVE (Infant Transnasal Humidified Rapid Insufflation Ventilatory Exchange): A Single-centre Prospective Randomized Controlled Trial.
Improvement of oxygenation during apnoea by i-THRIVE Infant Transnasal Humidified Rapid Insufflation Ventilatory Exchange A single-centre prospective randomized controlled trial.
Read the detailed description
High-Flow nasal cannula therapy is the administration of heated, humidified and blended air/oxygen via nasal cannula at rates of at least 2 L/kg bodyweight /min. This high-flow nasal cannula therapy was developed in neonatal intensive care unit for preterm babies with respiratory pauses as an alternative to continuous pressure support (CPAP). Due to its ease of use and safety to apply to a wide range of indication, this oxygen delivery therapy is increasingly gaining interest for providing respiratory support in paediatric and adult patients with respiratory failure in the ICU. High-flow nasal cannula therapy is applied in preterm infant with respiratory distress syndrome, apnoea of prematurity or a respiratory support after extubation. In the adult population the use of HFNCT focuses on hypoxemic respiratory failure and improvement reduction of hypoxemia during intubation in the anesthesia environment. A new application for high-flow nasal cannula therapy in adults is the extension of apnoea time in patients with difficult airways who are undergoing general anesthesia. In this environment a new term for this kind of oxygen therapy was created: THRIVE transnasal humidified rapid-insufflation ventilatory exchange. To distinguish this kind of high-flow nasal cannula therapy in apnoeic patients from the one in the paediatric ICU or ward the investigators use the term i-THRIVE for infant transnasal humidified rapid insufflation ventilation exchange.
Due to the increased oxygen consumption and the reduced functional residual capacity, neonates, infants, and small children have a reduced apnoea tolerance compared to adults. Furthermore infants and small children have a greater closing capacity, which increases the airway collapse under general anesthesia and muscle paralysis. A direct consequence is that hypoxemia is very likely to occur after cessation of spontaneous or assisted ventilation during induction of anesthesia. Apnoea without supplemental oxygen leads to hypoxemia in a 1-year-old infant without preoxygenation within seconds. All paediatric (and adult) patients undergoing general anesthesia have at least a brief period of apnoea during intubation between the time the face-mask is removed from the patient and the tube is placed in the trachea. Therefore, at least short phases of deoxygenation may occur.
However if anesthesia needs to be provided in emergency situations or in the presence of a difficult airway, the rate of complication increases rapidly. In these circumstances methods that reduce desaturation incidents during prolonged difficult intubation are desirable. Due to oxygen toxicity in neonates or small children, prevention of hypoxemia with oxygen concentration below 60% would be favourable in this setting. Despite promising pilot results with high-flow nasal cannula therapy, it is unknown whether this technique is superior to low-flow oxygenation with high concentration and whether it is necessary to apply high-flow nasal cannula therapy with high (80-100%) versus low (30-50%) concentration oxygen.
This study investigates under controlled circumstances the concept of i-THRIVE to prolong the apnoea time without deoxygenation and to improve safety of airway management in paediatric patients. Furthermore, this study enables to quantify the effects of different oxygen concentrations with high-flow nasal cannula therapy and distinguishes it better from conventional low-flow apnoeic oxygenation methods.
- Conditions
- Preoxygenation
- Being tested
- Nasal oxygen flow
- Keywords
- Apnoea time, preoxygenation, difficult airway, emergency
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal oxygen flowProcedure or surgery
Nasal oxygen flow during apnoea
| Study group | Role | What they receive |
|---|---|---|
| High-flow 100% oxygen | Active comparator | Nasal oxygen flow Receives: Procedure: Nasal oxygen flow |
| Low-flow 100% oxygen | Active comparator | Nasal oxygen flow Receives: Procedure: Nasal oxygen flow |
| High-flow 30% oxygen | Active comparator | Nasal oxygen flow Receives: Procedure: Nasal oxygen flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until desaturation from SpO2 100% to 95% measured by pulse oxymetry
Measured: up to ten minutes during intervention
Secondary outcomes (2)
TcCO2mmHg level
Measured: study intervention, around 15 minutes
TcO2mmHg level
Measured: study intervention, around 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMay 2017
- Study completionMay 2017
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 PreoxygenationStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Greif, MD MME FERC, Study chair, University hospital Bern and University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979067
- Sponsor's protocol ID
- 2016-01516
- Other IDs
- 2016
- Acronym
- i-Thrive
- Status last verified
- May 2017
- First submitted
- 15 Nov 2016
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Riva T, Pedersen TH, Seiler S, Kasper N, Theiler L, Greif R, Kleine-Brueggeney M. Transnasal humidified rapid insufflation ventilatory exchange for oxygenation of children during apnoea: a prospective randomised controlled trial. Br J Anaesth. 2018 Mar;120(3):592-599. doi: 10.1016/j.bja.2017.12.017. Epub 2018 Jan 27.
PubMed 29452816
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Oxygenation During Apnoea by i-THRIVE (Infant Transnasal Humidified Rapid Insufflation Ventilatory Exchange): A Single-centre Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02979067
- Acronym / sponsor ID
- i-Thrive / 2016-01516
- Conditions
- Preoxygenation
- Keywords
- Apnoea time, preoxygenation, difficult airway, emergency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 1 Dec 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.
Improvement of oxygenation during apnoea by i-THRIVE Infant Transnasal Humidified Rapid Insufflation Ventilatory Exchange A single-centre prospective randomized controlled trial.
Detailed description
High-Flow nasal cannula therapy is the administration of heated, humidified and blended air/oxygen via nasal cannula at rates of at least 2 L/kg bodyweight /min. This high-flow nasal cannula therapy was developed in neonatal intensive care unit for preterm babies with respiratory pauses as an alternative to continuous pressure support (CPAP). Due to its ease of use and safety to apply to a wide range of indication, this oxygen delivery therapy is increasingly gaining interest for providing respiratory support in paediatric and adult patients with respiratory failure in the ICU. High-flow nasal cannula therapy is applied in preterm infant with respiratory distress syndrome, apnoea of prematurity or a respiratory support after extubation. In the adult population the use of HFNCT focuses on hypoxemic respiratory failure and improvement reduction of hypoxemia during intubation in the anesthesia environment. A new application for high-flow nasal cannula therapy in adults is the extension of apnoea time in patients with difficult airways who are undergoing general anesthesia. In this environment a new term for this kind of oxygen therapy was created: THRIVE transnasal humidified rapid-insufflation ventilatory exchange. To distinguish this kind of high-flow nasal cannula therapy in apnoeic patients from the one in the paediatric ICU or ward the investigators use the term i-THRIVE for infant transnasal humidified rapid insufflation ventilation exchange.
Due to the increased oxygen consumption and the reduced functional residual capacity, neonates, infants, and small children have a reduced apnoea tolerance compared to adults. Furthermore infants and small children have a greater closing capacity, which increases the airway collapse under general anesthesia and muscle paralysis. A direct consequence is that hypoxemia is very likely to occur after cessation of spontaneous or assisted ventilation during induction of anesthesia. Apnoea without supplemental oxygen leads to hypoxemia in a 1-year-old infant without preoxygenation within seconds. All paediatric (and adult) patients undergoing general anesthesia have at least a brief period of apnoea during intubation between the time the face-mask is removed from the patient and the tube is placed in the trachea. Therefore, at least short phases of deoxygenation may occur.
However if anesthesia needs to be provided in emergency situations or in the presence of a difficult airway, the rate of complication increases rapidly. In these circumstances methods that reduce desaturation incidents during prolonged difficult intubation are desirable. Due to oxygen toxicity in neonates or small children, prevention of hypoxemia with oxygen concentration below 60% would be favourable in this setting. Despite promising pilot results with high-flow nasal cannula therapy, it is unknown whether this technique is superior to low-flow oxygenation with high concentration and whether it is necessary to apply high-flow nasal cannula therapy with high (80-100%) versus low (30-50%) concentration oxygen.
This study investigates under controlled circumstances the concept of i-THRIVE to prolong the apnoea time without deoxygenation and to improve safety of airway management in paediatric patients. Furthermore, this study enables to quantify the effects of different oxygen concentrations with high-flow nasal cannula therapy and distinguishes it better from conventional low-flow apnoeic oxygenation methods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-flow 100% oxygen | Active comparator | Procedure: Nasal oxygen flowNasal oxygen flow |
| Low-flow 100% oxygen | Active comparator | Procedure: Nasal oxygen flowNasal oxygen flow |
| High-flow 30% oxygen | Active comparator | Procedure: Nasal oxygen flowNasal oxygen flow |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 10-20 kg
- ASA 1+2
- Written informed consent
- Speaking German
Key exclusion criteria (6 listed)
- Difficult intubation
- Oxygen dependency
- Congenital heart or lung disease
- BMI >30g/m2
- High aspiration risk
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 |
|---|---|---|
| Nasal oxygen flowNasal oxygen flow during apnoea | Procedure or surgery | High-flow 100% oxygen, High-flow 30% oxygen, Low-flow 100% oxygen |
Primary outcome
Time until desaturation from SpO2 100% to 95% measured by pulse oxymetry
Time frame: up to ten minutes during intervention
2 secondary outcomes
TcCO2mmHg level
Time frame: study intervention, around 15 minutes
TcO2mmHg level
Time frame: study intervention, around 15 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 12 May 2017.
- Derived from this study: PubMed 29452816Riva T, Pedersen TH, Seiler S, Kasper N, Theiler L, Greif R, Kleine-Brueggeney M. Transnasal humidified rapid insufflation ventilatory exchange for oxygenation of children during apnoea: a prospective randomised controlled trial. Br J Anaesth. 2018 Mar;120(3):592-599. doi: 10.1016/j.bja.2017.12.017. Epub 2018 Jan 27.
- 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 MME FERC study chair
University hospital Bern and University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal oxygen flow in people with Preoxygenation, run by Insel Gruppe AG, University Hospital Bern at 1 site 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 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 12 May 2017. 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 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?
Time until desaturation from SpO2 100% to 95% measured by pulse oxymetry (time frame: up to ten minutes during intervention). 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 NCT02979067, 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 12 May 2017.