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ApneaFUTURENCT05672329

Functional Residual Capacity Under Apnoeic Oxygenation with Different Flow Rates in Children

A study testing 0.2 L/kg/min, FiO2 1.0 + continuous jaw thrust, 2 L/kg/min, FiO2 1.0 + continuous jaw thrust and 4 L/kg/min, FiO2 1.0 + continuous jaw thrust in people with Apnea and Anesthesia, run by Thomas Riva 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

During induction of general anaesthesia physiological breathing stops and needs to be artificially established with facemask ventilation, and finally tracheal intubation or placement of a supraglottic airway. During the airway management, when lungs are not or only poorly ventilated, there is a risk for atelectasis. Read more about this study

Who is it for?
Ages Up to 16 years
Conditions the study is for
Apnea, Anesthesia, Intubation Complication
What is being tested?
0.2 L/kg/min, FiO2 1.0 + continuous jaw thrust, 2 L/kg/min, FiO2 1.0 + continuous jaw thrust and 4 L/kg/min, FiO2 1.0 + continuous jaw thrust
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteSwitzerland
Study dates
9 Jan 2023to 2 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 Up to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Written informed consent by legal guardian
  • Paediatric patients undergoing elective surgery requiring general anaesthesia at the Bern University Hospital - Inselspital in Bern
  • Child weight between 10-20kg
  • American Society of Anesthesiology (ASA) physical status 1 \& 2 (healthy child, no severe co-morbidities)

Who cannot join

  • Known or suspected difficult intubation
  • Oxygen dependency
  • Congenital heart or lung disease
  • Obesity BMI (kg/m2) >30
  • High aspiration risk (requiring rapid sequence intubation).

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern

    Bern, Canton of Bern, 3010

Other trials in Switzerland

About this study

Official title: Functional Residual Capacity Under Apnoeic Oxygenation with Different Flow Rates in Children: a Single-centre Prospective Randomized Controlled Trial

During induction of general anaesthesia physiological breathing stops and needs to be artificially established with facemask ventilation, and finally tracheal intubation or placement of a supraglottic airway. During the airway management, when lungs are not or only poorly ventilated, there is a risk for atelectasis. These atelectasis can contribute to respiratory adverse events (e.g. pulmonary infection or respiratory insufficiency) during or after general anaesthesia. High-flow nasal oxygen (HFNO) is the administration of heated, humidified and blended air/oxygen mixture via a nasal cannula at rates ≥ 2 L/kg/min. HFNO used during airway management (i.e. intubation) can extend the tolerance for apnea, the time from end of physiological breathing until artificial ventilation is established. The main objective of this study is thus to investigate the variations of poorly ventilated lung units (i.e., silent spaces) as a surrogate for functional residual capacity measured by electrical impedance tomography to dynamically assess atelectasis formation and regression under apnoeic oxygenation with different flow rates.

Read the detailed description

High-flow nasal oxygen (HFNO) is the administration of heated, humidified and blended air/oxygen via nasal cannula at rates ≥ 2 L/kg/min. HFNO is an open system that can be used with nasal prongs of different sizes and was developed in neonatal intensive care unit for preterm babies with apnoea as alternative to continuous positive airway pressure (CPAP). Due to its ease of use and safety to apply to a wide range of indication HFNO is increasingly gaining interest for providing respiratory support in paediatric patients and in adults in ICU with respiratory failure. In adult populations, the use of HFNO permits to prevent desaturation during tracheal intubation of intensive care patients with mild-to-moderate hypoxemia. An application for HFNO in adults and children, is the extension of safe apnoea in patients who were undergoing general anaesthesia for hypopharyngeal or laryngo-tracheal surgery. This method, the so-called safe apnoeic oxygenation, also prevents hypoxemia in children during intubation. By using this technique, Patel et al. demonstrated a significate prolongation of apnoea time and proposed a ventilatory effect, as these studies revealed a slower increase in pCO2 than physiologically was expected. In these studies, researchers compared their data to studies from the 1950-ies, where CO2 increase during apnoea was investigated. In contrast, the investigators' previous research projects with HFNO did not confirm the claimed ventilatory effect in children and adults.

Furthermore studies performed in spontaneously breathing neonates and adults have shown the ability of HFNO to generate some increase in pharyngeal pressure, which could explain the improvement of oxygenation despite prolongation of apnea time. The investigators' previous study on adult patients showed that a relevant increase of pressure was nearly absent while patient's mouth was open. Currently, there is no data on the physiological pressure that is generated in the subglottic airway in apneic children treated with HFNO. The traditional measurement of intratracheal pressure with a catheter in the trachea is considered to pose a risk in small children.

The main objective of this study is thus to investigate the variations of poorly ventilated lung units (i.e., silent spaces) as a surrogate for functional residual capacity measured by electrical impedance tomography to dynamically assess atelectasis formation and regression under apnoeic oxygenation with different flow rates.

Eligible children will receive premedication with Midazolam rectal/oral 0.5 mg/kg or Dexmedetomidine nasal 2 mcg/kg 30 minutes before the beginning of the procedure (local SOPs of the paediatric anaesthesia departments). Mandatory monitoring will consist of non-invasive peripheral oxygen saturation (SpO2), heartrate (HR), and non-invasive blood pressure (NIBP). An intravenous line for drugs injection will be placed.

After start of anaesthesia (="induction"), adequate face-mask ventilation will be established. The sealed envelope for randomisation will then be opened. Standard anaesthesia will be continued using of intravenous propofol. Anaesthetic depth will be assessed using NarcotrendTM (NarcotrendTM, Hannover, Germany), maintaining values between 40 and 60. Additional study related non-invasive monitoring: transcutaneous tcCO2 and O2 (ToscaTM, Radiometer, Neuilly-Plaisance, France) measurement, thoracic electrical impedance tomography (EIT, PulmoVista 500, Draeger, Luebeck, Germany) and NIRS (Niro-200NX (Hamamatsu, Tokyo, Japan). ECG, pulse-oximetry, blood pressure, Narcotrend (NarcotrendTM, Hannover, Germany), thoracic EIT will be measured continuously, starting before induction while spontaneous breathing and ending 1 minute after the recruitment-manoeuvre. All patients will receive neuromuscular blockade medication of 2 x ED95 (standard intubation dose) to facilitate airway management. Neuromuscular block will be assessed using train-of-four (TOF) monitoring (TOF-Watch, Organon Ltd, Dublin, Ireland). A TOF value of zero before apnoea start and throughout the whole procedure will be deemed essential.

After that one minute of pressure support mask ventilation (Pmax 20 cm H20) with a backup respiratory rate of 20/min, normalized at a volume of 6-8 ml.kg-1 with 100% oxygen and will be applied. The ventilation will be discontinued, and the child will be left apnoeic for 5 minutes receiving oxygen according to the randomisation.

Children will be randomized to receive three different flow rates of 100% oxygen, warmed and humidified with the OptiFlow device (Fisher\&PaykelTM, Auckland, New Zealand):

  • group 1): 0.2 l/kg/min + continuous jaw thrust
  • group 2): 2 l/kg/min + continuous jaw thrust
  • group 3): 4 l/kg/min + continuous jaw thrust (control group)
  • Group 4): 2 l/kg/min with OptiFlow FiO2 1.0 using OptiFlow-Switch system by Fisher\&Paykel.

The nostrils must not be occluded by the nasal cannula by more than 50%. The time until desaturation from SpO2 100% to SpO2 95% will be measured. A chest ultrasound at end of intervention after definitive airway management will prove that no pneumothorax developed during the procedure.

Break-up criteria during apnoea are: SpO2 below 95%, transcutaneous CO2 above 70 mmHg, or time of apnoea >5 minutes, a decrease of NIRS >30% from baseline.

Being tested
0.2 L/kg/min, FiO2 1.0 + continuous jaw thrust, 2 L/kg/min, FiO2 1.0 + continuous jaw thrust, 4 L/kg/min, FiO2 1.0 + continuous jaw thrust, 2 L/kg/min using OptiFlow-Switch system, FiO2 1.0 + continuous jaw thrust
Keywords
Atelectasis, Apnoeic oxygenation, High-flow nasal oxygen, Silent spaces, Functional residual capacity, Paediatric anaesthesia
Medical subject headings
Apnea, Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.2 L/kg/min, FiO2 1.0 + continuous jaw thrustOther

    Apnoeic Oxygenation with flow rate 0.2 L/kg/min using OptiFlow system by Fisher\&Paykel and an oxygen inspiration concentration FiO2 of 1.0

  • 2 L/kg/min, FiO2 1.0 + continuous jaw thrustOther

    Apnoeic Oxygenation with flow rate 2 L/kg/min using OptiFlow system by Fisher\&Paykel and an oxygen inspiration concentration FiO2 of 1.0

  • 4 L/kg/min, FiO2 1.0 + continuous jaw thrustOther

    Apnoeic Oxygenation with flow rate 4 L/kg/min using OptiFlow system by Fisher\&Paykel and an oxygen inspiration concentration FiO2 of 1.0

  • 2 L/kg/min using OptiFlow-Switch system, FiO2 1.0 + continuous jaw thrustOther

    Apnoeic Oxygenation with flow rate 2 L/kg/min using OptiFlow-Switch system by Fisher\&Paykel and an oxygen inspiration concentration FiO2 of 1.0

Study groups in NCT05672329
Study groupRoleWhat they receive
Group 1: Low-flow apnoeic oxygenationExperimentalGroup 1) 0.2 L/kg/min using OptiFlow system by Fisher\&Paykel and an oxygen inspiration concentration FiO2 of 1.0;
Receives: Other: 0.2 L/kg/min, FiO2 1.0 + continuous jaw thrust
Group 2: High-flow apnoeic oxygenationExperimentalGroup 2) 2 L/kg/min using OptiFlow system by Fisher\&Paykel and an oxygen inspiration concentration FiO2 of 1.0;
Receives: Other: 2 L/kg/min, FiO2 1.0 + continuous jaw thrust
Group 3: Control group apnoeic oxygenationActive comparatorGroup 3) 4 L/kg/min using OptiFlow system by Fisher\&Paykel and an oxygen inspiration concentration FiO2 of 1.0;
Receives: Other: 4 L/kg/min, FiO2 1.0 + continuous jaw thrust
Group 4: High-flow apnoeic oxygenationExperimentalGroup 4): 2 l/kg/min with OptiFlow FiO2 1.0 using OptiFlow-Switch system by Fisher\&Paykel
Receives: Other: 2 L/kg/min using OptiFlow-Switch system, FiO2 1.0 + continuous jaw thrust

What is being measured

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

  1. Total change in lung impedance

    The total change in lung impedance measured in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT), normalized to the impedance amplitude during mechanical ventilation at 6-8 ml.kg-1 measured after 5 min of apnea compared to baseline measurement.

    Data given in percent (%) for silent spaces and delta EELI.

    Measured: 5 Minutes

Secondary outcomes (7)
  1. Time until desaturation to SpO2 95%

    In case of desaturation within the predefined apnoea time: time (in seconds) until desaturation from peripheral saturation (SpO2) 100% to 95%, measured by peripheral pulse oximetry in percent (%).

    Measured: 5 Minutes

  2. Changes in transcutaneous CO2

    Changes in transcutaneous carbon dioxide (tcCO2) in mmHg/min during apnoea time

    Measured: 5 Minutes

  3. Changes in brain oxygenation

    Changes in brain oxygenation measured by near infrared spectroscopy (NIRS) during apnoea time given in percent (%)

    Measured: 5 Minutes

  4. Changes in silent spaces and EELI after 1 min PSV

    The total change in lung impedance measured in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography, normalized to the impedance amplitude during mechanical ventilation at 6-8 ml.kg-1 after induction and 1 minute of pressure supported ventilation with backup frequency (PSV) at 6-8 ml/kg.

    Data given in percent (%) for silent spaces and delta EELI.

    Measured: 5 Minutes

  5. Changes in silent spaces and EELI after airway management

    Changes in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography after airway management (i.e. supraglottic airway or intubation).

    Data given in percent (%) for silent spaces and delta EELI.

    Measured: 5 Minutes

  6. Changes in silent spaces and EELI after recruitment manoeuvre

    Changes in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography after recruitment manoeuvre and 1 minute of mechanical ventilation at 6-8 ml/kg.

    Data given in percent (%) for silent spaces and delta EELI.

    Measured: 5 Minutes

  7. Time to 25%, 50% and 75% of total change in lung impedance

    Time to 25%, 50% and 75% of total change in lung impedance by using electrical impedance tomography in seconds (s).

    Measured: 5 Minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2023
  2. Study start9 Jan 2023
  3. Primary completion30 Apr 2024
  4. Study completion2 May 2024

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
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05672329
Sponsor's protocol ID
Fuchs-Riva2022
Acronym
FUTURE
Status last verified
May 2024
First submitted
21 Dec 2022
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lippuner R, Pellaud C, Huber M, Greif R, Disma N, Riva T, Fuchs A, Riedel T. Efficacy of a lung recruitment manoeuvre in children undergoing general anaesthesia with a supraglottic airway. Br J Anaesth. 2025 Nov;135(5):1537-1542. doi: 10.1016/j.bja.2025.08.016. Epub 2025 Sep 23.

    PubMed 40993003
  • Aebli J, Bohnenblust V, Koepp-Medina G, Ahsani-Nasab S, Huber M, Greif R, Disma N, Riva T, Riedel T, Fuchs A. Lung Volume Change Under Apnoeic Oxygenation With Different Flow Rates in Children: A Single-Centre Prospective Randomized Controlled Non-Inferiority Trial. Paediatr Anaesth. 2026 Jan;36(1):36-42. doi: 10.1111/pan.70018. Epub 2025 Jul 18.

    PubMed 40679126

Questions about this trial

What is this clinical trial studying?

A study testing 0.2 L/kg/min, FiO2 1.0 + continuous jaw thrust, 2 L/kg/min, FiO2 1.0 + continuous jaw thrust and 4 L/kg/min, FiO2 1.0 + continuous jaw thrust in people with Apnea and Anesthesia, run by Thomas Riva 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 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 19 Sep 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 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?

Total change in lung impedance (time frame: 5 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 NCT05672329, which also lists 2 linked publications.

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 Sep 2024.

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