Apnoeic Oxygenation by Nasal Cannula During Airway Management in Children Undergoing General Anaesthesia.

Not Applicable

Completed

• Conditions: Apnoeic Oxygenation
• Interventions: Device: Apnoeic oxygenation

• Registration Number: NCT03271827
• Lead Sponsor: University of Birmingham

Brief Summary

Airway management is a core clinical skill in anaesthesia. Pre-oxygenation prior to induction of anaesthesia is standard practice to prevent desaturation. Apnoeic oxygenation in adults is effective and prolongs the time to desaturation. The effectiveness of apnoeic oxygenation in the adult is well document, however evidence in the paediatric is lacking. Therefore, the aim of this study was to investigate the effectiveness of apnoeic oxygenation during airway management in children.

This was a pilot randomised controlled trial. Patients were randomised to either receive apnoeic oxygenation or standard care during the induction of anaesthesia. The primary outcome was the duration of safe apnoea, defined as a composite of the time to first event, either time for SpO2 to drop to 92% or time to successfully secure the airway, and the lowest SpO2 observed during airway management. Secondary outcomes were number of patients whose SpO2 dropped below 95% and number of patients whose SpO2 dropped below 92%.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2016-03
• Study Completion: 2016-07
• Status Verified: 2017-08
• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2017-08-31
• Last Update Submitted: 2017-08-31
• Study First Posted: 2017-09-05
• Last Update Posted: 2017-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients were included who were scheduled for elective surgery under general anaesthesia.
• Age: one eight years old.
• ASA I and II only.
• Patients with normal cardiorespiratory function.

Exclusion Criteria

• Children undergoing dental surgeries in which nasal intubation is needed.
• Patients who suffered from quick drops in oxygen saturation more rapidly than healthy children due to different reasons such as: respiratory and pulmonary diseases, active or recent upper respiratory tract infection, syndromes with cardiopulmonary pathologies, cardiac anomalies, anaemia, depressed respiratory effort, ventilation/perfusion imbalance, Obstructive Sleep Apnoea (OSA), and airway obstruction.
• Patients reported with nasal obstruction.
• Patients with grades of laryngoscopic view (Cormack Lahane) greater than II, which indicates upper airway obstruction.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apnoeic oxygenation group	Apnoeic oxygenation	Standard airway management + 3 L/min of oxygen by nasal cannula

Primary Outcome Measures

Name	Time	Method
Time to first event	Estimated: 10 seconds to 3 minutes	Time to first event: either time for SpO2 to fall to 92% or time to successfully secure the airway as usual practice without allowing desaturation
The lowest SpO2 observed during airway management	Estimated: 10 seconds to 3 minutes	The lowest SpO2 observed during airway management

Secondary Outcome Measures

Name	Time	Method
Number of patients whose SpO2 dropped below 95%	Estimated: 10 seconds to 3 minutes	Number of patients whose SpO2 dropped below 95%
Number of patients whose SpO2 dropped below 92%	Estimated: 10 seconds to 3 minutes	Number of patients whose SpO2 dropped below 92%