Retrospective Study on Prolonged Sedation Effects With Inhaled Agents in PICU

Completed

• Conditions: Mechanical Ventilation

• Registration Number: NCT05064592
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-09-22
• Study First Posted: 2021-10-01
• Study Start: 2022-01-26
• Primary Completion: 2022-04-28
• Study Completion: 2022-04-28
• Status Verified: 2023-08
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dosages of hypnotics first 24 hours following the introduction of halogens	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 Outcome Measures

Name	Time	Method
Clinical sedation score	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
Dosages of opioids in the 24 hours following the introduction of halogens	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.
Morphinic / hypnotic dosages at the end of halogenated use	Day 0	Show a reduction \> 20% in morphinic / hypnotic dosages at the end of halogenated use (\> 24 hours).
Hypnotics / sedatives / curares dosages in populations of ARDS patients at the end of the use of halogens	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).
Halogenated failure criteria	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.
Tachyphylaxis to halogenated	Day 0	Withdrawal syndrome within 24 hours of stopping halogenated: proportion of tachyphylaxis to halogenated.
Dosages of ketamine within 24 hours of the introduction of halogens	Day 0	Show a reduction \>20% in ketamine dosages within 24 hours of the introduction of halogens (mg / kg / h).
Ventilatory parameters in patients with ARDS during the period of halogen use	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).
Total duration of sedation, analgesia and curarization	Day 0	Determine the total duration of sedation, analgesia and curarization.
Withdrawal syndrome: morphine and hypnotics	Day 0	Determine the proportion of withdrawal syndrome : morphine and hypnotics in %.
Adverse effects of secondary to prolonged administration of Sevoflurane or Isoflurane	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.

Trial Locations

Locations (2)

Hôpital Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

Hôpital Armand Trousseau; 🇫🇷 Paris, France