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

NCT ID: NCT03271827

Last Updated: 2017-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-07-31

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%.

Conditions

Apnoeic Oxygenation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Apnoeic oxygenation group

Standard airway management + 3 L/min of oxygen by nasal cannula

Group Type: EXPERIMENTAL

Apnoeic oxygenation

Intervention Type: DEVICE

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

Standard care group

Standard airway management

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Apnoeic oxygenation

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Abdullah International Medical Research Center

OTHER

Sponsor Role: collaborator

Cardiff University

OTHER

Sponsor Role: collaborator

University of Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Lafi Olayan

Research fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lafi Olayan, MSc

Role: PRINCIPAL_INVESTIGATOR

King Abdullah International Research Center (KAIMRC)

References

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Reference Type: BACKGROUND

PMID: 22050948 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 20400000 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 25536868 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 16674614 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 10702447 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 16873387 (View on PubMed)

Olayan L, Alatassi A, Patel J, Milton S. Apnoeic oxygenation by nasal cannula during airway management in children undergoing general anaesthesia: a pilot randomised controlled trial. Perioper Med (Lond). 2018 Feb 21;7:3. doi: 10.1186/s13741-018-0083-x. eCollection 2018.

Reference Type: DERIVED

PMID: 29484172 (View on PubMed)

Other Identifiers

SP15/134

Identifier Type: -

Identifier Source: org_study_id