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Completed

NCT Number: NCT03271827

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

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%.

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Key information

Conditions

Apnoeic Oxygenation

Age range

1 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apnoeic oxygenation

Device

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

Primary outcomes

  1. Time to first event

    Time frame: 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

  2. The lowest SpO2 observed during airway management

    Time frame: Estimated: 10 seconds to 3 minutes

    The lowest SpO2 observed during airway management

Secondary outcomes

  1. Number of patients whose SpO2 dropped below 95%

    Time frame: Estimated: 10 seconds to 3 minutes

    Number of patients whose SpO2 dropped below 95%

  2. Number of patients whose SpO2 dropped below 92%

    Time frame: Estimated: 10 seconds to 3 minutes

    Number of patients whose SpO2 dropped below 92%

Sponsors and collaborators

Lead sponsor

University of Birmingham

Other

Collaborators

  • Cardiff University
  • King Abdullah International Medical Research Center

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 5, 2017
Registry last updated
Sep 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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