Two Modalities of Ventilation on the Occurrence of Respiratory Complications During Inhalational Anaesthetic Induction in Children (PEDIAMOVE)
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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Florent Baudin, Pr
- 전화번호: +00334 72 12 97 35
- 이메일: florent.baudin@chu-lyon.fr
연구 연락처 백업
- 이름: Clarisse Saunier
- 전화번호: +0033427856264
- 이메일: clarisse.saunier@chu-lyon.fr
연구 장소
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Lyon, 프랑스, 69677
- Hopital Femme Mere Enfant
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연락하다:
- Florent Baudin, Pr
- 전화번호: +00334 72 12 97 35
- 이메일: florent.baudin@chu-lyon.fr
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연락하다:
- Eloise Cercueil, Dr
- 전화번호: +00334 27 85 52 48
- 이메일: Eloise.cercueil@chu-lyon.fr
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수석 연구원:
- Eloise Cercueil, Dr
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Marseille, 프랑스, 13385
- Hôpitaux Universitaires de Marseille Timone
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연락하다:
- Fabrice Michel, Dr
- 전화번호: +334.91.96.47.58
- 이메일: fabrice.michel@ap-hm.fr
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수석 연구원:
- Fabrice Michel, Dr
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Montpellier, 프랑스, 34295
- Centre hospitalier universitaire de Montpellier
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연락하다:
- Chrystelle SOLA, Dr
- 전화번호: (+33)4 67 33 24 48
- 이메일: c-sola@chu-montpellier.fr
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수석 연구원:
- Chrystelle SOLA, Dr
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Nantes, 프랑스, 44000
- CHU de Nantes
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연락하다:
- Jules LECOMTE, Dr
- 전화번호: (+33) 2 40 08 32 50
- 이메일: jules.lecomte@chu-nantes.fr
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수석 연구원:
- Jules Lecomte, Dr
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Paris, 프랑스, 75019
- Hopital Robert Debre
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연락하다:
- Souhayl DAHMANI, Dr
- 전화번호: (+33)1 40 03 22 21
- 이메일: souhayl.dahmani@rdb.aphp.fr
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수석 연구원:
- Souhayl DAHMANI, Dr
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Paris, 프랑스, 75012
- Hôpital Armand Trousseau
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연락하다:
- Mireille Nasr, Dr
- 전화번호: +00331 44 73 51 20
- 이메일: mireille.nasr@aphp.fr
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수석 연구원:
- Mireille Nasr, Dr
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Reims, 프랑스, 51092
- Centre Hospitalier Universitaire de Reims
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연락하다:
- Delphine Michelet, Dr
- 전화번호: (+33)3 26 83 25 37
- 이메일: dmichelet@chu-reims.fr
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수석 연구원:
- Delpine Michelet, Dr
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Strasbourg, 프랑스, 67200
- Hôpital de Hautepierre
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연락하다:
- Claire BOPP, Dr
- 전화번호: (+33) 3 88 12 61 38
- 이메일: claire.bopp@chru-strasbourg.fr
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수석 연구원:
- Claire BOPP, Dr
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Toulouse, 프랑스, 31300
- CHU Toulouse - Hôpitaux des enfants
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연락하다:
- Delhpine KERN, Dr
- 전화번호: (+33)5 34 55 84 23
- 이메일: kern.d@chu-toulouse.fr
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수석 연구원:
- Delhpine KERN, Dr
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: PEEP + PSV
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. |
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다른: Induction in spontaneous breathing
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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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of respiratory adverse events among laryngospasm, bronchospasm, oxygen desaturation, airway obstruction and severe cough
기간: Day 0
|
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Day 0
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of respiratory adverse events among laryngospasm, bronchospasm and oxygen desaturation < 90%.
기간: Day 0
|
Risk difference and risk ratio at T4
|
Day 0
|
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Number of respiratory adverse events among airway obstruction, desaturation < 95% for more than 10s and severe cough
기간: Day 0
|
Risk difference and risk ratio at T4
|
Day 0
|
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Use of oropharyngeal cannula or need for manual ventilation for difficult ventilation.
기간: Day 0
|
Risk difference and risk ratio at T4
|
Day 0
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Number of attempts to control the airways
기간: Day 0
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Attempts at tracheal intubation or laryngeal mask insertion, as reported by the physician in charge. Risk difference and risk ratio at T4 |
Day 0
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Number of gastric distension requiring evacuation
기간: Day 0
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Reported by the physician in charge.
Risk difference and risk ratio at T4
|
Day 0
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Pressure support (cmH2O) and tidal volumes (ml/Kg)
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 69HCL24_0926
약물 및 장치 정보, 연구 문서
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