Retrospective Study on Prolonged Sedation Effects With Inhaled Agents in PICU (RESPIRE)

Retrospective Study on Prolonged Sedation Effects With Inhaled Agents in Pediatric Intensive Care Unit

The objective of the study is to evaluate the effects of halogenated gases on sedation and analgesia, to describe the tolerance and to determine the risk factors for failure, in pediatric intensive care patients during prolonged sedation.

This study will be based on the medical records of patients hospitalized between 2015 and 2020.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation

Detailed Description

Sedation is a major therapeutic element in patients in intensive care under artificial ventilation, in order to allow their comfort and patient-ventilator synchronization. The use of benzodiazepines in combination with opioids is common practice. However, during prolonged sedation, the effects wane, then the doses must be increased, responsible for an increase in the incidence of a significant withdrawal syndrome in the recovery phase, a source of delay in extubation or early reintubation.

The use of halogenated anesthetic gases is now possible in pediatric intensive care in these patients on artificial ventilation.

Their efficacy and tolerance in prolonged use must be evaluated. Their use could improve the sedative effects, reduce the doses of benzodiazepines and opioids used, and reduce unwanted effects in terms of withdrawal syndrome.

The objective of the study is to evaluate the effects of halogenated gases on sedation and analgesia, to describe the tolerance and to determine the risk factors for failure, in pediatric intensive care patients during prolonged sedation.

This study will be based on the medical records of patients hospitalized between 2015 and 2020.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Le Kremlin-Bicêtre, France, 94270
    • Hôpital Bicêtre
  • Paris, France, 75012
    • Hôpital Armand Trousseau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Minor patients hospitalized between 2015 and 2020 in PICU and having been under sedation and prolonged invasive mechanical ventilation (> 72h).

Description

Inclusion Criteria:

• Minor patient over 1 month old (and over 36 WA of corrected age) and under 18 years old
• Hospitalized in neonatal or pediatric intensive care unit
• Invasive mechanical ventilation over 72 hours
• Prolonged sedation greater than 72 hours

Exclusion Criteria:

- Opposition of the holders of parental authority of the minor patient or the adult patient to the use of the data for the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients; Medical records of minor patients hospitalized between 2015 and 2020 in PICU and having been under sedation and prolonged invasive mechanical ventilation (> 72h).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosages of hypnotics first 24 hours following the introduction of halogens	Show a reduction in hypnotics dosages, calculated in Midazolam equivalent in µg / kg / h, during the first 24 hours after the introduction of halogens. A decrease will be significant if it is greater than 20% compared to the basal level before initiation of the halogens.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosages of opioids in the 24 hours following the introduction of halogens	Show a reduction > 20% in opioids dosages (calculated in morphine equivalent, in µg / kg / h, in the 24 hours following the introduction of halogens.	Day 0
Dosages of ketamine within 24 hours of the introduction of halogens	Show a reduction >20% in ketamine dosages within 24 hours of the introduction of halogens (mg / kg / h).	Day 0
Morphinic / hypnotic dosages at the end of halogenated use	Show a reduction > 20% in morphinic / hypnotic dosages at the end of halogenated use (> 24 hours).	Day 0
Clinical sedation score	COMFORT BEHAVIOUR scale. Measures pain and excess sedation in intensive care, starting in the neonatal period. Score: from 6 to 30 : Excess sedation: 6 to 10 Comfortable child, sedated without excess: 11 to 17 Child in borderline condition, possible pain: 17 to 22 Child clearly uncomfortable, painful: 23 to 30	Day 0
Hypnotics / sedatives / curares dosages in populations of ARDS patients at the end of the use of halogens	Show a reduction> 20% in hypnotics / sedatives / curares dosages (µg/kg/h) in populations of Acute Respiratory Distress Syndrome patients (ARDS patients) with and without extracorporeal membrane oxygenation (ECMO) at the end of the use of halogens (> 24 hours).	Day 0
Ventilatory parameters in patients with ARDS during the period of halogen use	Show a reduction > 20% in ventilatory parameters (PEEP in mmHg, Tidal volume in ml, PaO2/FiO2 ratio) in patients with ARDS during the period of halogen use (<24 hours).	Day 0
Total duration of sedation, analgesia and curarization	Determine the total duration of sedation, analgesia and curarization.	Day 0
Halogenated failure criteria	Comparison of patients who shown an improvement of the COMFORT B scale 24 hours after introducing halogenated between patients who shown no significant reduction of COMFORT B scale.	Day 0
Withdrawal syndrome: morphine and hypnotics	Determine the proportion of withdrawal syndrome : morphine and hypnotics in %.	Day 0
Tachyphylaxis to halogenated	Withdrawal syndrome within 24 hours of stopping halogenated: proportion of tachyphylaxis to halogenated.	Day 0
Adverse effects of secondary to prolonged administration of Sevoflurane or Isoflurane	Describe the proportions of side effects: Malignant hyperthermia, Arterial hypotension, Tachycardia, Bradypnea or apnea, Bronchospasm, Arrhythmias, Cytolytic hepatitis, Chills, nausea, vomiting upon awakening, Irritation of the respiratory tract, Headache.	Day 0

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC Necker Cochin, France
• Investigators: Principal Investigator: Pierre-Louis Léger, MD, PhD, Assistance Publique - Hôpitaux de Paris; Study Director: Léo Berger, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Halogenated volatile anaesthetics for prolonged sedation in pediatric intensive care unit: first experience in two French pediatric intensive care units. https://doi.org/10.1007/s44253-023-00009-y.Léo Berger, Yohan Soreze, Jérome Rambaud, Julie Starck, Yael Levy, Pierre Tissières, Jordi Miatello, Luc Morin & Pierre-Louis Léger

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2022
• Primary Completion (Actual): April 28, 2022
• Study Completion (Actual): April 28, 2022

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Pediatric intensive care unit; Artificial ventilation; Prolonged sedation effects; Halogenated anesthetic gases; Inhaled agents; Benzodiazepines in combination with opioids; Halogenated anesthetic gases efficacity and tolerance
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: APHP211236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No