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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Switzerland

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 groups in NCT02979067
Study groupRoleWhat they receive
High-flow 100% oxygenActive comparatorNasal oxygen flow
Receives: Procedure: Nasal oxygen flow
Low-flow 100% oxygenActive comparatorNasal oxygen flow
Receives: Procedure: Nasal oxygen flow
High-flow 30% oxygenActive comparatorNasal oxygen flow
Receives: Procedure: Nasal oxygen flow

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time until desaturation from SpO2 100% to 95% measured by pulse oxymetry

    Measured: up to ten minutes during intervention

Secondary outcomes (2)
  1. TcCO2mmHg level

    Measured: study intervention, around 15 minutes

  2. 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.

  1. First posted1 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionMay 2017
  4. Study completionMay 2017

Resources

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)
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

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.

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