Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576596
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Apnoeic Oxygenation During Pediatric Tracheal Intubation a Randomized Controlled Single-blinded Clinical Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Apnoeic Oxygenation During Pediatric Tracheal Intubation a Randomized Controlled Single-blinded Clinical Trial ApOx-Pedi-Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized controlled single-blinded clinical trial is to evaluate the effectiveness of apnoeic Oxygenation in pediatric anesthesia The main question it aims to answer are
primary outcome measure Can the use of apnoeic oxygenation reduce the rate of oxygen saturation drops
secondary outcome measure
Is there a difference in first-pass-success between the groups
Differences in the time until the drop in saturation between the two groups
What is the incidence of anaesthesia-related complications eg aspiration -hypoxia circulatory failure etc
The study participants are randomised 11 into two groups Either in the control group without the use of apnoeic oxygenation or in the intervention group with the use of apnoeic oxygenation
primary outcome measure Can the use of apnoeic oxygenation reduce the rate of oxygen saturation drops
secondary outcome measure
Is there a difference in first-pass-success between the groups
Differences in the time until the drop in saturation between the two groups
What is the incidence of anaesthesia-related complications eg aspiration -hypoxia circulatory failure etc
The study participants are randomised 11 into two groups Either in the control group without the use of apnoeic oxygenation or in the intervention group with the use of apnoeic oxygenation
Detailed Description:
The incidence of intraoperative hypoxaemia in children is high and age-dependent An incidence of over 10 is reported in8- to 16-year-old children and over50 in newborns Severe respiratory critical events occur in paediatric anaesthesia with an incidence of 31 After the onset of apnoea hypoxaemia develops more rapidly in children than in adults which is due to increased oxygen consumption a lower functional residual capacity and an increased closing capacity These events can lead to permanent neurological damage or death One approach to preventing adverse respiratory events due to hypoxaemia during paediatric anaesthesia is the use of apnoeic oxygenation The principle is to supply oxygen to the airways of anaesthetised patients via a conventional nasal cannula As less carbon dioxide is produced than oxygen is consumed during apnoea the supply of oxygen to the upper airways leads to an inward diffusion of oxygen which prolongs the time until desaturation and hypoxaemia occur This also extends the safe apnoea time and the anaesthetist has more time to secure the airway As the incidence and severity of arterial oxygen desaturation is higher in critically ill children compared to healthy children this vulnerable group in particular could benefit from apnoeic oxygenation Apnoeic oxygenation is increasingly becoming a standard technique in paediatric anaesthesia with applications ranging from induction of anaesthesia in the operating theatre and standard airway management to the management of difficult airways In its current guidelines the European Society of Anaesthesiology and Intensive Care recommends the use of apnoeic oxygenation in the airway management of newborns and infants The main aim of this study is to evaluate the effectiveness of apnoeic oxygenation in terms of time to desaturation and hypoxaemia as well as the impact of apnoeic oxygenation on intubation success in anaesthetised children
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None