Pediatric Surgery Clinical Trial
— OPTINECKOfficial title:
A Randomised Controlled Trial Comparing Pre-oxygenation Strategies With High-flow Humidified Nasal Oxygenation Versus Apnoeic Facemask Oxygenation During Rapid Sequence Induction in Children Aged Less Then 11 Years
This randomised study aims to compare the utilization of high-flow humidified nasal oxygenation (HFNO) with standard care, using apnoeic facemask oxygenation, during rapid sequence induction (RSI) of anesthesia in young children. 170 children aged less then 11 years, admitted to the operating room for surgery and with a medical indication of a RSI of anesthesia will be recruited in one university hospital (Necker-Enfants-Malades in Paris). Children will be randomly assigned into two groups: the control group will benefit of standard care and the HFNO group will receive heated and humidified oxygen through a nasal cannula device during pre-oxygenation and apnoea time prior to tracheal intubation. HFNO has been evaluated and showed benefits in rapid sequence induction of anesthesia in adults and prolonged apnea time before desaturation in children. To the investigators' knowledge the potential benefit of HFNO during RSI in young children remain to be evaluated.
Status | Recruiting |
Enrollment | 170 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 10 Years |
Eligibility | Inclusion Criteria: - child from birth until 10 years - patient needing (elective or in emergency) surgery under general anesthesia requiring tracheal intubation and fulfilling all criteria for a rapid sequence induction - Parents or legal guardians signed the Informed consent form - Social insurance affiliation Exclusion Criteria - child having one or more contraindication to use high flow nasal oxygenation: - Nasal obstruction - Recent trauma of aero-digestives tracts - Epistaxis - Known or suspected fracture of the skull base - Cephalo-spinal fluid leak or all other communication between nasal space and intracranial space - Tuberculosis or other nasal or lung infection - Pneumothorax or pneumo-mediastin documented or suspected - Complete limitation of mouth opening |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Necker - Enfants malades | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intubation without oxygen desaturation episode | Intubation without oxygen desaturation episode, defined as pulsed oxymetry <95% during the rapid sequence induction process of anesthesia in the operating room. | Up to 10 minutes | |
Secondary | Oxygen saturation level | Measurement of the lowest oxygen saturation during the tracheal intubation process | Up to 10 minutes | |
Secondary | Tracheal intubation without facemask reventilation | Tracheal intubation without facemask reventilation | Up to 10 minutes | |
Secondary | Number of attempted tracheal intubations required to succeed the process | Number of attempted tracheal intubations required to succeed the process | Up to 10 minutes | |
Secondary | Occurrence of all adverse events | Occurrence of all adverse events during tracheal intubation in the operating room (linked or not to the use of HFNO) | until the exit of the recovery room | |
Secondary | Satisfaction of the anaesthetist and the anaesthesia team regarding the use of HFNO | Questionnaire about satisfaction, the use of the procedure, stress level and potential genes | Exit of the recovery room |
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