Cerebral Hypoperfusion, Endotracheal Intubation, Premedication
Conditions
Brief summary
Observational ancillary study of the PRETTINEO study (ClinicalTrials.gov Identifier: NCT01490580) which is a multicenter double blind randomized controlled trial comparing atropine+propofol vs atropine+atracurium+sufentanil as a premedication prior to endotracheal intubation of the neonate. Primary outcome: * Cerebral desaturation defined by a rScO2 delta \>20% from the baseline value (before premedication). * Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication, calculated from rScO2 and pulse oximetry with the formula FTOE=SaO2 - rScO2/SaO2 . Hypothesis: atropine + propofol compared to atropine+atracurium+sufentanil does not increase the frequency of cerebral hypoxemia.
Interventions
Atropine bolus: 20 µg/kg Propofol injected over 60 seconds: 1 mg/kg for infants \< 1000g - Renewable once 2.5 mg/kg for infants \> 1000G - Possible additional dose of 1 mg/kg
Atropine bolus: 20 µg/kg Atracurium: 0.3 mg/kg- Possible additional dose of 0.1 mg/kg Sufentanil: 0.1 µg/kg for infants \< 1000g 0.2 µg/kg for infants \> 1000g
Sponsors
Association Clinique Thérapeutique Infantile du val de Marne
Centre de Recherche Clinique du CHIC
Centre Hospitalier Intercommunal Creteil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
Inclusion criteria
* Corrected age \< 45 weeks of gestational age * Currently hospitalized in a neonatal intensive care unit * Requiring semi-urgent or elective intubation * Equipped with a reliable and permeable IV line * Parental consent
Exclusion criteria
* Lack of parental consent * Parental refusal * Sedative or anesthetic treatment in the previous 24 hours * Hemodynamic compromise defined as mean blood pressure\< corrected GA and/or refill time \> 3 seconds * Upper airway malformation * Life-threatening situation requiring immediate intubation * Inclusion in another trial not permitting any other participation * Impossibility to establish venous access * Any contra-indication to any experimental drug * Skin lesions or burns of the forehead
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral desaturation | from 1 minute before to 60 minutes after the start of premedication | rScO2 delta \>20% from the baseline value (before premedication). rScO2 recording measured by INVOS 1500C 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first drug injection |
| FTOE (Fractional Tissue Oxygen Extraction) | from 1 minute before to 60 minutes after the start of premedication | Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication. FTOE is calculated from rScO2 and pulse oxymetry (SaO2) with the formula FTOE = SaO2 - rScO2/SaO2. Values will be recorded 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first drug injection. |
Countries
France
Outcome results
None listed