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Retrospective Study on Prolonged Sedation Effects With Inhaled Agents in PICU

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05064592
Acronym
RESPIRE
Enrollment
50
Registered
2021-10-01
Start date
2022-01-26
Completion date
2022-04-28
Last updated
2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Sponsors

URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dosages of hypnotics first 24 hours following the introduction of halogensDay 0Show 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.

Secondary

MeasureTime frameDescription
Dosages of ketamine within 24 hours of the introduction of halogensDay 0Show a reduction \>20% in ketamine dosages within 24 hours of the introduction of halogens (mg / kg / h).
Morphinic / hypnotic dosages at the end of halogenated useDay 0Show a reduction \> 20% in morphinic / hypnotic dosages at the end of halogenated use (\> 24 hours).
Clinical sedation scoreDay 0COMFORT 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
Hypnotics / sedatives / curares dosages in populations of ARDS patients at the end of the use of halogensDay 0Show 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).
Ventilatory parameters in patients with ARDS during the period of halogen useDay 0Show 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).
Dosages of opioids in the 24 hours following the introduction of halogensDay 0Show a reduction \> 20% in opioids dosages (calculated in morphine equivalent, in µg / kg / h, in the 24 hours following the introduction of halogens.
Halogenated failure criteriaDay 0Comparison 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.
Withdrawal syndrome: morphine and hypnoticsDay 0Determine the proportion of withdrawal syndrome : morphine and hypnotics in %.
Tachyphylaxis to halogenatedDay 0Withdrawal syndrome within 24 hours of stopping halogenated: proportion of tachyphylaxis to halogenated.
Adverse effects of secondary to prolonged administration of Sevoflurane or IsofluraneDay 0Describe 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.
Total duration of sedation, analgesia and curarizationDay 0Determine the total duration of sedation, analgesia and curarization.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026