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Completed

NCT Number: NCT05064592

Retrospective Study on Prolonged Sedation Effects With Inhaled Agents in PICU

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.

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Key information

Conditions

Mechanical Ventilation

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Bicêtre, Le Kremlin-Bicêtre, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Dosages of hypnotics first 24 hours following the introduction of halogens

    Time frame: Day 0

    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.

Secondary outcomes

  1. Dosages of opioids in the 24 hours following the introduction of halogens

    Time frame: Day 0

    Show a reduction > 20% in opioids dosages (calculated in morphine equivalent, in µg / kg / h, in the 24 hours following the introduction of halogens.

  2. Dosages of ketamine within 24 hours of the introduction of halogens

    Time frame: Day 0

    Show a reduction >20% in ketamine dosages within 24 hours of the introduction of halogens (mg / kg / h).

  3. Morphinic / hypnotic dosages at the end of halogenated use

    Time frame: Day 0

    Show a reduction > 20% in morphinic / hypnotic dosages at the end of halogenated use (> 24 hours).

  4. Clinical sedation score

    Time frame: Day 0

    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

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

    Time frame: Day 0

    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).

  6. Ventilatory parameters in patients with ARDS during the period of halogen use

    Time frame: Day 0

    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).

  7. Total duration of sedation, analgesia and curarization

    Time frame: Day 0

    Determine the total duration of sedation, analgesia and curarization.

  8. Halogenated failure criteria

    Time frame: Day 0

    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.

  9. Withdrawal syndrome: morphine and hypnotics

    Time frame: Day 0

    Determine the proportion of withdrawal syndrome : morphine and hypnotics in %.

  10. Tachyphylaxis to halogenated

    Time frame: Day 0

    Withdrawal syndrome within 24 hours of stopping halogenated: proportion of tachyphylaxis to halogenated.

  11. Adverse effects of secondary to prolonged administration of Sevoflurane or Isoflurane

    Time frame: Day 0

    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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: RESPIRE

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 1, 2021
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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