Mechanical VentilationRESPIRENCT05064592
Retrospective Study on Prolonged Sedation Effects With Inhaled Agents in PICU
An observational study of Mechanical Ventilation, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Mechanical Ventilation
- How many people
- 50 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Jan 2022to 28 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Minor patients hospitalized between 2015 and 2020 in PICU and having been under sedation and prolonged invasive mechanical ventilation (> 72h).
Who may be able to join
- 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
Who cannot join
- Opposition of the holders of parental authority of the minor patient or the adult patient to the use of the data for the study
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Hôpital Armand Trousseau
Paris, 75012
About this study
Official title: Retrospective Study on Prolonged Sedation Effects With Inhaled Agents in Pediatric Intensive Care Unit
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.
Read the 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.
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Medical records of minor patients hospitalized between 2015 and 2020 in PICU and having been under sedation and prolonged invasive mechanical ventilation (> 72h). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (11)
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.
Measured: Day 0
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).
Measured: Day 0
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).
Measured: Day 0
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
Measured: Day 0
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).
Measured: Day 0
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).
Measured: Day 0
Total duration of sedation, analgesia and curarization
Determine the total duration of sedation, analgesia and curarization.
Measured: Day 0
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.
Measured: Day 0
Withdrawal syndrome: morphine and hypnotics
Determine the proportion of withdrawal syndrome : morphine and hypnotics in %.
Measured: Day 0
Tachyphylaxis to halogenated
Withdrawal syndrome within 24 hours of stopping halogenated: proportion of tachyphylaxis to halogenated.
Measured: Day 0
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start26 Jan 2022
- Primary completion28 Apr 2022
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Pierre-Louis Léger, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisLéo Berger, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064592
- Sponsor's protocol ID
- APHP211236
- Acronym
- RESPIRE
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2021
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on Prolonged Sedation Effects With Inhaled Agents in Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05064592
- Acronym / sponsor ID
- RESPIRE / APHP211236
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Medical records of minor patients hospitalized between 2015 and 2020 in PICU and having been under sedation and prolonged invasive mechanical ventilation (> 72h). |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Minor patients hospitalized between 2015 and 2020 in PICU and having been under sedation and prolonged invasive mechanical ventilation (> 72h).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Opposition of the holders of parental authority of the minor patient or the adult patient to the use of the data for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
11 secondary outcomes
Dosages of opioids in the 24 hours following the introduction of halogens
Time frame: Day 0
Dosages of ketamine within 24 hours of the introduction of halogens
Time frame: Day 0
Morphinic / hypnotic dosages at the end of halogenated use
Time frame: Day 0
Clinical sedation score
Time frame: Day 0
Hypnotics / sedatives / curares dosages in populations of ARDS patients at the end of the use of halogens
Time frame: Day 0
Ventilatory parameters in patients with ARDS during the period of halogen use
Time frame: Day 0
Total duration of sedation, analgesia and curarization
Time frame: Day 0
Halogenated failure criteria
Time frame: Day 0
Withdrawal syndrome: morphine and hypnotics
Time frame: Day 0
Tachyphylaxis to halogenated
Time frame: Day 0
Adverse effects of secondary to prolonged administration of Sevoflurane or Isoflurane
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publicationHalogenated 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
- Individual participant dataSharing planned: No
Related trials for Mechanical Ventilation
Not yet recruitingObservational study
Early Switch in Moderate ARDS
Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
Not yet recruitingObservational study
Predicting the Need for Invasive Mechanical Ventilation Using Different Risk Scores
High Flow Oxygen Therapy, Non Invasive Ventilation (NIV)
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Not yet recruitingObservational study
Detecting Early Weaning-induced Pulmonary Oedema Using Lung Impedance Negative Trend During Spontaneous Breathing Trials
Weaning-induced Pulmonary Edema, Mechanical Ventilation Weaning
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Louis Léger, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Léo Berger, MD study director
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosages of hypnotics first 24 hours following the introduction of halogens (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05064592, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.