Apneic Oxygénation by Nasal Canula During Infants Airway Management Study

NCT03967769 | Unknown

• 2 other identifiers: Oxyneo2018-004127-36
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized clinical trial investigating the utility of apneic oxygenation via high flow nasal cannulae during airway management for infants general anaesthesia. Three groups will be compared, a control group at 0 L/min, a 0,2L/Kg/min and a 1L/Kg/min group. The primary outcome will be the time (in seconds) between onset of apnea and one of theses end-points : desaturation (SPO2 \<95%) or Airway management completed.

Conditions

Infant Apnea; Surgical Procedure, Unspecified; Airway Management

Keywords

Apnoeic oxygenation; Airway management; Oxygen insufflation; Paediatric general anaesthesia

Outcome Measures

Primary Outcomes (1)

• Time between apnoea and issues

  Time, in seconds, between the onset of Apnoea (No EtCO2 on the capnogram) and one of these two Issues : * SpO2\< 95% * Airway Management Completed (Orotracheal intubation completed and 3 similar capnograms on the respirator)

  Start at the onset of Apnoea

Secondary Outcomes (6)

• Minimal SpO2 during the procedure (%)

  Between Onset of apnoea and airway management completed

• Time to SpO2 = 90% (in seconds)

  During Airway Management, after Apnoea Onset

• Numbers of Laryngoscopy attempts (n)

  During Airway management

• Need to Face Mask Reventilating (Yes/No)

  During Airway management

• Area under SpO2 curve

  During Airway management

Study Arms (3)

Standard Practice

NO INTERVENTION

Infants will have high Flow nasal cannulae placed into the nares before induction. They will be removed from the nares at the end of the study when the airway has been secured. There will be no oxygen flowing through the cannulae in this group during the study.

Low Flow oxygenation

EXPERIMENTAL

Infants will have conventional nasal cannulae into the nares prior to induction of anesthesia. They will be removed from the nares at the end of the study when the airway has been secured. There will be 0,2L/kg/min of oxygen flowing through the cannulae in this group during the study.

Device: High Flow nasal Cannula

High Flow Oxygenation

EXPERIMENTAL

Infants will have conventional nasal cannulae into the nares prior to induction of anesthesia. They will be removed from the nares at the end of the study when the airway has been secured. There will be 1L/kg/min of oxygen flowing through the cannulae in this group during the study.

Device: High Flow nasal Cannula

Interventions

High Flow nasal Cannula DEVICE

Apnoeic Oxygenation by High Flow Nasal Cannulae

High Flow Oxygenation; Low Flow oxygenation

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants Between 0 (post-conceptionnal age \>41 weeks post Amenorrhea) and 24 months of life
• Scheduled for elective surgery under general anesthesia
• Need of orotracheal Intubation by direct laryngoscopy or Video-laryngoscopy

You may not qualify if:

• Emergency surgery
• Crush Induction needed
• High clinical risk of difficult airway management
• Premature before 1 month of life

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU

Clermont-Ferrand, France

RECRUITING

Study Officials

• Adeline Gerst

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+33 4 73 754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: At each participating center, patients will be followed up for primary and secondary endpoints by members of the research staff who will be unaware of the trial group allocation. Information on whether the primary and secondary outcomes occur will be collected and entered into the electronic web-based case report form (eCRF) by trial or clinical trained personal (clinical research associate), blinded to the allocation group, under the supervision of the local principal investigator (PI) or designee who will also be unaware of the trial group allocation. Finally, the independent trial statistician and the members of the data monitoring and safety committee (DMSC) will also remain blinded for the allocation during analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric prospective, randomized, stratified, parallel-group clinical trial with concealed allocation to 3 groups of Apnoeic Oxygenation during Airway management for general anesthesia in elective surgery. All participants will receive French actual standard of care of surgery and anesthesia.

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 30, 2019
• Study Start: August 5, 2019
• Primary Completion: August 4, 2020
• Study Completion: November 4, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-06

Locations

FR (1)