Anaesthetic InductionPEDIAMOVENCT07767851
Two Modalities of Ventilation on the Occurrence of Respiratory Complications During Inhalational Anaesthetic Induction in Children
A study testing Induction with PEEP (5 cmH2O) and PSV (2-12 cmH2O) and Induction in spontaneous breathing in people with Anaesthetic Induction and Respiratory Complications of Care, run by Hospices Civils de Lyon at 9 sites in France.
Trial summary
Induction of anesthesia by inhalation is the most common method of induction (70% in France) for young children admitted for non-emergency surgery. It has the advantage of not requiring an intravenous line. Read more about this study
- Who is it for?
- Ages 3 months to 6 years
- Conditions the study is for
- Anaesthetic Induction, Respiratory Complications of Care, Pediatrics
- What is being tested?
- Induction with PEEP (5 cmH2O) and PSV (2-12 cmH2O) and Induction in spontaneous breathing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,032 participants
- Where
- 9 sitesFrance
- Study dates
- 1 Nov 2026to 1 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child between 3 months and 6 years old
- Without significant comorbidity (ASA 1 or 2)
- Admitted for elective or emergency/urgent surgery under general anesthesia
- With induction of anaesthesia by inhalation by sevoflurane on the machine circuit
- With airway control by intubation tube or supraglottic device
- Consent of at least one parent or legal guardian
Who cannot join
- Children with severe upper respiratory tract infection (severe moist cough, fever and lethargy, oxygen requirement) in the last 7 days requiring intravenous induction or postpone of the surgery
- Thoracic surgery with selective control of intubation
- Criteria for difficult intubation or known history of difficult intubation
- Children with a contraindication to sevoflurane (ex: risk of malignant hyperthermia)
- Children asking for intravenous induction or requiring rapid sequence induction
- Children with significant cardiac disease (pulmonary hypertension, cyanotic heart disease,…)
Show all 10Show fewer
- Children not affiliated or beneficiary of a health insurance system
- Children participating in other interventional research with an exclusion period still in progress at inclusion
- Failure of venous access after 30 min or more than 5 attempts
- Parents' consent withdrawal
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites
Hôpital Femme Mère Enfant
Lyon, 69677
Eloise Cercueil, Dr, +00334 27 85 52 48, Eloise.cercueil@chu-lyon.fr
Florent Baudin, Pr, +00334 72 12 97 35, florent.baudin@chu-lyon.fr
Hôpitaux Universitaires de Marseille Timone
Marseille, 13385
Fabrice Michel, Dr, +334.91.96.47.58, fabrice.michel@ap-hm.fr
Fabrice Michel, Dr
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295
Chrystelle SOLA, Dr, (+33)4 67 33 24 48, c-sola@chu-montpellier.fr
Chrystelle SOLA, Dr
CHU de Nantes
Nantes, 44000
Jules LECOMTE, Dr, (+33) 2 40 08 32 50, jules.lecomte@chu-nantes.fr
Jules Lecomte, Dr
Hôpital Armand Trousseau
Paris, 75012
Mireille Nasr, Dr, +00331 44 73 51 20, mireille.nasr@aphp.fr
Mireille Nasr, Dr
Hôpital Robert Debré
Paris, 75019
Souhayl DAHMANI, Dr, (+33)1 40 03 22 21, souhayl.dahmani@rdb.aphp.fr
Souhayl DAHMANI, Dr
Centre Hospitalier Universitaire de Reims
Reims, 51092
Delphine Michelet, Dr, (+33)3 26 83 25 37, dmichelet@chu-reims.fr
Delpine Michelet, Dr
Hôpital de Hautepierre
Strasbourg, 67200
Claire BOPP, Dr, (+33) 3 88 12 61 38, claire.bopp@chru-strasbourg.fr
Claire BOPP, Dr
CHU Toulouse - Hôpitaux des enfants
Toulouse, 31300
Delhpine KERN, Dr, (+33)5 34 55 84 23, kern.d@chu-toulouse.fr
Delhpine KERN, Dr
About this study
Official title: Comparison of Two MOdalities of VEntilation on the Occurrence of Respiratory Complications During Inhalational Anaesthetic Induction in Children: a Multicentre Randomised Controlled Trial.
Induction of anesthesia by inhalation is the most common method of induction (70% in France) for young children admitted for non-emergency surgery. It has the advantage of not requiring an intravenous line.
Serious respiratory adverse events such as laryngospasm or bronchospasm remain common in young children during anesthesia induction (approximately 4%) and can reach up to 30% when mild respiratory adverse events (coughing, desaturation < 95%, airway obstruction) are included.
Read more
Traditionally, inhalation induction is performed under spontaneous ventilation using the anesthesia ventilator circuit. However, modern ventilators offer the option of applying positive end-expiratory pressure (PEEP) and pressure support ventilation (PSV). Several physiological studies suggest that the use of PEEP + PSV during anesthesia may help maintain airway patency, minute ventilation, and functional residual capacity (FRC).
Our hypothesis is that administering PEEP + PSV at the time of induction may reduce the risk of respiratory complications.
The primary objective is to demonstrate that induction of anesthesia using PEP + PSV, compared with induction of anesthesia under spontaneous ventilation, reduces the risk of adverse respiratory events in children requiring general anesthesia with planned inhalational induction.
- Being tested
- Induction with PEEP (5 cmH2O) and PSV (2-12 cmH2O), Induction in spontaneous breathing
- Keywords
- Anaesthetic induction, Ventilation, Respiratory complications, Pediatrics
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction with PEEP (5 cmH2O) and PSV (2-12 cmH2O)Procedure or surgery
Sevoflurane will initially be at 6% (with a fresh gas flow between 2L/min and 10L/min) or increase progressively according to local habits, which can be reduced between 4 and 6% during the installation of the vascular access and increased again to 6% before the control of the airway. The FiO2 will be set at 80% and can be increased up to 100% in case of desaturation.
In the experimental group, the level of PEEP will be set at 5 cmH2O and inspiratory support between 2 and 12 cmH2O and adjusted by the anaesthetist in charge to optimize respiratory mechanics and obtain a physiological tidal volume of 8ml/kg.
Induction in spontaneous breathingProcedure or surgery
Sevoflurane will initially be at 6% (with a fresh gas flow between 2L/min and 10L/min) or increase progressively according to local habits, which can be reduced between 4 and 6% during the installation of the vascular access and increased again to 6% before the control of the airway. The FiO2 will be set at 80% and can be increased up to 100% in case of desaturation.
In the control group, there is no PEEP
| Study group | Role | What they receive |
|---|---|---|
| PEEP + PSV | Experimental | Induction with PEEP (5 cmH2O) and PSV (2-12 cmH2O) Receives: Procedure: Induction with PEEP (5 cmH2O) and PSV (2-12 cmH2O) |
| Induction in spontaneous breathing | Other | Not described Receives: Procedure: Induction in spontaneous breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of respiratory adverse events among laryngospasm, bronchospasm, oxygen desaturation, airway obstruction and severe cough
- Laryngospasm: complete or partial obstruction of the airway associated with rigidity of the abdominal and thoracic muscles measured by the physician in charge
- Bronchospasm: increase in work of breathing, particularly in exhalation (signs of respiratory distress) with wheezing measured by the physician in charge
- Oxygen desaturation: <95% more than 10 sec or < 90% measured by the physician in charge
- Airway obstruction: airway obstruction with inspiratory noise and increased work of breathing or requiring manual ventilation measured by the physician in charge
- Severe cough: coughing fit lasting more than 10 sec or requiring drug intervention (intravenous anaesthetic agents, lidocaine, neuromuscular blockade agents) measured by the physician in charge
Measured: Day 0
Secondary outcomes (6)
Number of respiratory adverse events among laryngospasm, bronchospasm and oxygen desaturation < 90%.
Risk difference and risk ratio at T4
Measured: Day 0
Number of respiratory adverse events among airway obstruction, desaturation < 95% for more than 10s and severe cough
Risk difference and risk ratio at T4
Measured: Day 0
Use of oropharyngeal cannula or need for manual ventilation for difficult ventilation.
Risk difference and risk ratio at T4
Measured: Day 0
Number of attempts to control the airways
Attempts at tracheal intubation or laryngeal mask insertion, as reported by the physician in charge.
Risk difference and risk ratio at T4
Measured: Day 0
Number of gastric distension requiring evacuation
Reported by the physician in charge. Risk difference and risk ratio at T4
Measured: Day 0
Pressure support (cmH2O) and tidal volumes (ml/Kg)
Pressure support (cmH2O) set on the ventilator by the physician in charge (continuous variable) Tidal volumes measured on the ventilator by the physician in charge (continuous variable)
Relation between the pressure support and the tidal volume at each time T1 and T2 separately
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaesthetic InductionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,032 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767851
- Sponsor's protocol ID
- 69HCL24_0926
- Acronym
- PEDIAMOVE
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two MOdalities of VEntilation on the Occurrence of Respiratory Complications During Inhalational Anaesthetic Induction in Children: a Multicentre Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT07767851
- Acronym / sponsor ID
- PEDIAMOVE / 69HCL24_0926
- Keywords
- Anaesthetic induction, Ventilation, Respiratory complications, Pediatrics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,032 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 17 Aug 2026 (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.
Induction of anesthesia by inhalation is the most common method of induction (70% in France) for young children admitted for non-emergency surgery. It has the advantage of not requiring an intravenous line.
Serious respiratory adverse events such as laryngospasm or bronchospasm remain common in young children during anesthesia induction (approximately 4%) and can reach up to 30% when mild respiratory adverse events (coughing, desaturation < 95%, airway obstruction) are included.
Traditionally, inhalation induction is performed under spontaneous ventilation using the anesthesia ventilator circuit. However, modern ventilators offer the option of applying positive end-expiratory pressure (PEEP) and pressure support ventilation (PSV). Several physiological studies suggest that the use of PEEP + PSV during anesthesia may help maintain airway patency, minute ventilation, and functional residual capacity (FRC).
Our hypothesis is that administering PEEP + PSV at the time of induction may reduce the risk of respiratory complications.
The primary objective is to demonstrate that induction of anesthesia using PEP + PSV, compared with induction of anesthesia under spontaneous ventilation, reduces the risk of adverse respiratory events in children requiring general anesthesia with planned inhalational induction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEP + PSV | Experimental | Procedure: Induction with PEEP (5 cmH2O) and PSV (2-12 cmH2O)Induction with PEEP (5 cmH2O) and PSV (2-12 cmH2O) |
| Induction in spontaneous breathing | Other | Procedure: Induction in spontaneous breathing |
Who may qualify
- Ages
- 3 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child between 3 months and 6 years old
- Without significant comorbidity (ASA 1 or 2)
- Admitted for elective or emergency/urgent surgery under general anesthesia
- With induction of anaesthesia by inhalation by sevoflurane on the machine circuit
- With airway control by intubation tube or supraglottic device
Key exclusion criteria (10 listed)
- Children with severe upper respiratory tract infection (severe moist cough, fever and lethargy, oxygen requirement) in the last 7 days requiring intravenous induction or postpone of the surgery
- Thoracic surgery with selective control of intubation
- Criteria for difficult intubation or known history of difficult intubation
- Children with a contraindication to sevoflurane (ex: risk of malignant hyperthermia)
- Children asking for intravenous induction or requiring rapid sequence induction
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 |
|---|---|---|
| Induction with PEEP (5 cmH2O) and PSV (2-12 cmH2O)Sevoflurane will initially be at 6% (with a fresh gas flow between 2L/min and 10L/min) or increase progressively according to local habits, which can be reduced between 4 and 6% during the installation of the vascular access and increased again to 6% before the control of the airway. The FiO2 will be set at 80% and can be increased up to 100% in case of desaturation. In the experimental group, the level of PEEP will be set at 5 cmH2O and inspiratory support between 2 and 12 cmH2O and adjusted by the anaesthetist in charge to optimize respiratory mechanics and obtain a physiological tidal volume of 8ml/kg. | Procedure or surgery | PEEP + PSV |
| Induction in spontaneous breathingSevoflurane will initially be at 6% (with a fresh gas flow between 2L/min and 10L/min) or increase progressively according to local habits, which can be reduced between 4 and 6% during the installation of the vascular access and increased again to 6% before the control of the airway. The FiO2 will be set at 80% and can be increased up to 100% in case of desaturation. In the control group, there is no PEEP | Procedure or surgery | Induction in spontaneous breathing |
Primary outcome
Number of respiratory adverse events among laryngospasm, bronchospasm, oxygen desaturation, airway obstruction and severe cough
Time frame: Day 0
* Laryngospasm: complete or partial obstruction of the airway associated with rigidity of the abdominal and thoracic muscles measured by the physician in charge * Bronchospasm: increase in work of breathing, particularly in exhalation (signs of respiratory distress) with wheezing measured by the physician in charge * Oxygen desaturation: <95% more than 10 sec or < 90% measured by the physician in charge * Airway obstruction: airway obstruction with inspiratory noise and increased work of breathing or requiring manual ventilation measured by the physician in charge * Severe cough: coughing fit lasting more than 10 sec or requiring drug intervention (intravenous anaesthetic agents, lidocaine, neuromuscular blockade agents) measured by the physician in charge
6 secondary outcomes
Number of respiratory adverse events among laryngospasm, bronchospasm and oxygen desaturation < 90%.
Time frame: Day 0
Number of respiratory adverse events among airway obstruction, desaturation < 95% for more than 10s and severe cough
Time frame: Day 0
Use of oropharyngeal cannula or need for manual ventilation for difficult ventilation.
Time frame: Day 0
Number of attempts to control the airways
Time frame: Day 0
Number of gastric distension requiring evacuation
Time frame: Day 0
Pressure support (cmH2O) and tidal volumes (ml/Kg)
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induction with PEEP (5 cmH2O) and PSV (2-12 cmH2O) and Induction in spontaneous breathing in people with Anaesthetic Induction and Respiratory Complications of Care, run by Hospices Civils de Lyon at 9 sites in France.
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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florent BAUDIN, Pr (+00334 72 12 97 35, florent.baudin@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of respiratory adverse events among laryngospasm, bronchospasm, oxygen desaturation, airway obstruction and severe cough (time frame: Day 0). 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 26 Oct 2026.