Retrospective Study on Prolonged Sedation Effects With Inhaled Agents in PICU

NCT05064592 | Completed

• 1 other identifier: APHP211236
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Mechanical Ventilation

Keywords

Artificial ventilation; Pediatric intensive care unit; Prolonged sedation effects; Halogenated anesthetic gases; Inhaled agents; Benzodiazepines in combination with opioids; Halogenated anesthetic gases efficacity and tolerance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Dosages of opioids in the 24 hours following the introduction of halogens

  Day 0

• Dosages of ketamine within 24 hours of the introduction of halogens

  Day 0

• Morphinic / hypnotic dosages at the end of halogenated use

  Day 0

• Clinical sedation score

  Day 0

• Hypnotics / sedatives / curares dosages in populations of ARDS patients at the end of the use of halogens

  Day 0

Study Arms (1)

Patients

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

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (2)

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Hôpital Armand Trousseau

Paris, 75012, France

Location

Related Publications (1)

• 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

  BACKGROUND

Study Officials

• Pierre-Louis Léger, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Léo Berger, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 1, 2021
• Study Start: January 26, 2022
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)