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Two Modalities of Ventilation on the Occurrence of Respiratory Complications During Inhalational Anaesthetic Induction in Children (PEDIAMOVE)

11. august 2026 oppdatert av: Hospices Civils de Lyon

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.

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

2032

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Frankrike
      • Lyon, Frankrike, 69677
        • Hopital Femme Mere Enfant
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Eloise Cercueil, Dr
      • Marseille, Frankrike, 13385
        • Hôpitaux Universitaires de Marseille Timone
        • Ta kontakt med:
        • Hovedetterforsker:
          • Fabrice Michel, Dr
      • Montpellier, Frankrike, 34295
        • Centre hospitalier universitaire de Montpellier
        • Ta kontakt med:
        • Hovedetterforsker:
          • Chrystelle SOLA, Dr
      • Nantes, Frankrike, 44000
        • CHU de Nantes
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jules Lecomte, Dr
      • Paris, Frankrike, 75019
        • Hopital Robert Debre
        • Ta kontakt med:
        • Hovedetterforsker:
          • Souhayl DAHMANI, Dr
      • Paris, Frankrike, 75012
        • Hôpital Armand Trousseau
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mireille Nasr, Dr
      • Reims, Frankrike, 51092
        • Centre Hospitalier Universitaire de Reims
        • Ta kontakt med:
        • Hovedetterforsker:
          • Delpine Michelet, Dr
      • Strasbourg, Frankrike, 67200
        • Hôpital de Hautepierre
        • Ta kontakt med:
        • Hovedetterforsker:
          • Claire BOPP, Dr
      • Toulouse, Frankrike, 31300
        • CHU Toulouse - Hôpitaux des enfants
        • Ta kontakt med:
        • Hovedetterforsker:
          • Delhpine KERN, Dr

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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,…)
  • 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

Exclusion Criteria :

  • Failure of venous access after 30 min or more than 5 attempts
  • Parents' consent withdrawal

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: PEEP + PSV
Induction with PEEP (5 cmH2O) and PSV (2-12 cmH2O)
Fremgangsmåte: 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.
Annen: Induction in spontaneous breathing
Fremgangsmåte: Induction in spontaneous breathing

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of respiratory adverse events among laryngospasm, bronchospasm, oxygen desaturation, airway obstruction and severe cough
Tidsramme: 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
Day 0

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of respiratory adverse events among laryngospasm, bronchospasm and oxygen desaturation < 90%.
Tidsramme: Day 0
Risk difference and risk ratio at T4
Day 0
Number of respiratory adverse events among airway obstruction, desaturation < 95% for more than 10s and severe cough
Tidsramme: Day 0
Risk difference and risk ratio at T4
Day 0
Use of oropharyngeal cannula or need for manual ventilation for difficult ventilation.
Tidsramme: Day 0
Risk difference and risk ratio at T4
Day 0
Number of attempts to control the airways
Tidsramme: Day 0

Attempts at tracheal intubation or laryngeal mask insertion, as reported by the physician in charge.

Risk difference and risk ratio at T4
Day 0
Number of gastric distension requiring evacuation
Tidsramme: Day 0
Reported by the physician in charge. Risk difference and risk ratio at T4
Day 0
Pressure support (cmH2O) and tidal volumes (ml/Kg)
Tidsramme: Day 0

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
Day 0

Samarbeidspartnere og etterforskere

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Sponsor

Hospices Civils de Lyon

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. september 2029

Studiet fullført (Antatt)

1. september 2029

Datoer for studieregistrering

Først innsendt

6. august 2026

Først innsendt som oppfylte QC-kriteriene

11. august 2026

Først lagt ut (Faktiske)

17. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 69HCL24_0926

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