Clinical trial NCT05064592: Retrospective Study on Prolonged Sedation Effects With Inhaled Agents in PICU
Official title: Retrospective Study on Prolonged Sedation Effects With Inhaled Agents in Pediatric Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dosages of hypnotics first 24 hours following the introduction of halogens
timeFrame: Day 0
Secondary outcomes:
measure: Dosages of opioids in the 24 hours following the introduction of halogens
timeFrame: Day 0
measure: Dosages of ketamine within 24 hours of the introduction of halogens
timeFrame: Day 0
measure: Morphinic / hypnotic dosages at the end of halogenated use
timeFrame: Day 0
measure: Clinical sedation score
timeFrame: Day 0
measure: Hypnotics / sedatives / curares dosages in populations of ARDS patients at the end of the use of halogens
timeFrame: Day 0
measure: Ventilatory parameters in patients with ARDS during the period of halogen use
timeFrame: Day 0
measure: Total duration of sedation, analgesia and curarization
timeFrame: Day 0
measure: Halogenated failure criteria
timeFrame: Day 0
measure: Withdrawal syndrome: morphine and hypnotics
timeFrame: Day 0
measure: Tachyphylaxis to halogenated
timeFrame: Day 0
measure: Adverse effects of secondary to prolonged administration of Sevoflurane or Isoflurane
timeFrame: Day 0
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
city: Paris
country: France
facility: Hôpital Armand Trousseau
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Pierre-Louis Léger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Léo Berger, MD
role: STUDY_DIRECTOR
References:
citation: 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