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

Apnoeic Oxygenation by Nasal Cannula During Airway Management in Children Undergoing General Anaesthesia: A Pilot Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03271827
Enrollment
30
Registered
2017-09-05
Start date
2016-01-31
Completion date
2016-07-31
Last updated
2017-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnoeic Oxygenation

Keywords

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

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%.

Interventions

3 L/min of oxygen by nasal cannula during as apnoeic oxygenation during airway management.

Sponsors

King Abdullah International Medical Research Center
CollaboratorOTHER
Cardiff University
CollaboratorOTHER
University of Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
1 Years to 8 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time to first eventEstimated: 10 seconds to 3 minutesTime 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 managementEstimated: 10 seconds to 3 minutesThe lowest SpO2 observed during airway management

Secondary

MeasureTime frameDescription
Number of patients whose SpO2 dropped below 95%Estimated: 10 seconds to 3 minutesNumber of patients whose SpO2 dropped below 95%
Number of patients whose SpO2 dropped below 92%Estimated: 10 seconds to 3 minutesNumber of patients whose SpO2 dropped below 92%

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026