Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-03 @ 8:40 PM
Study NCT ID:
NCT03967769
Status:
UNKNOWN
Last Update Posted:
2020-07-07
First Post:
2019-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Apneic Oxygénation by Nasal Canula During Infants Airway Management Study
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Apneic Oxygénation by Nasal Canula During Infants Airway Management Study
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Oxyeno
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.
Detailed Description:
Airway management can be a life saving therapy. One major complication that may occur during airway management is a lack of oxygen in the blood, especially in peadiatric population, due to anatomical and physiological considerations. If severe or prolonged, this lack of oxygen can result in permanent brain damage, damage to other vital organs or even death. Pre-oxygenation prior to induction of anaesthesia is standard practice to prevent desaturation and hypoxemia. Apnoeic oxygenation in adults is effective and prolongs the time to desaturation. Apneic oxygenation is a novel method of delivering oxygen to a patient despite a lack of active respiration (i.e. the patient is not breathing on their own and the investigators are not providing the patient an artificial breath). The simplest and least invasive method to provide apneic oxygenation is the application of oxygen through nasal cannula during airway management. The effectiveness of apnoeic oxygenation in the adult is well document, especially in bariatric population or ICU, however only few study are interesting about pediatric population. Recent studies suggest that high flow is similar to low flow oxygenotherapy. Therefore, the aim of this study was to investigate the effectiveness of apnoeic oxygenation during airway management in infants.
This is a randomized clinical trial investigating the utility of apneic oxygenation via high flow nasal cannula during airway management for infant's general anesthesia. 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 these end-points : desaturation (SPO2 \<95%) or Airway management completed.
All infants included will receive french actual standard of care concerning general anesthesia and peri-operative medicine.
This is a randomized clinical trial investigating the utility of apneic oxygenation via high flow nasal cannula during airway management for infant's general anesthesia. 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 these end-points : desaturation (SPO2 \<95%) or Airway management completed.
All infants included will receive french actual standard of care concerning general anesthesia and peri-operative medicine.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2018-004127-36 | EUDRACT_NUMBER | None | View |