Retrospective Study on Prolonged Sedation Effects With Inhaled Agents in PICU

Mechanical Ventilation Clinical Trial

— RESPIRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05064592
• Other study ID #: APHP211236
• Status: Completed
• Start date: January 26, 2022
• Est. completion date: April 28, 2022

Study information

• Verified date: August 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 28, 2022
• Est. primary completion date: April 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation
• Respiratory Aspiration

Locations

Country	Name	City	State
France	Hôpital Bicêtre	Le Kremlin-Bicêtre
France	Hôpital Armand Trousseau	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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, Ya

Outcome

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