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Nasal oxygen therapy during paediatric direct laryngoscopy and endotracheal intubation.

In children undergoing a general anaesthetic does supplemental nasal oxygen therapy , compared to no supplemental oxygen, prevent hypoxia during the induction - intubation -ventilation period.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613001101774
Enrollment
40
Registered
2013-10-02
Start date
2013-09-01
Completion date
2014-09-01
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Avoiding hypoxia through the administration of oxygen is a fundamental part of safe anaesthesia. Giving oxygen before induction (pre-oxygenation) , during ventilation with a mask and then following intubation is standard practice throughout the world. Oxygen levels are then maintained throughout the remainder of the anaesthetic and during the recovery period until the patient is conscious and capable of breathing spontaneously on air. When induction of a general anaesthetic occurs, the placement of an endotracheal tube is often required to maintain a safe and secure airway throughout the anaesthetic. Traditionally, this procedure is performed by direct laryngoscopy using a laryngoscope , which allows the anaesthetist to visualise the airway and place the endotracheal tube into the correct part of the airway.. Direct laryngoscopy normally occurs without the administration of supplementary oxygen. Hypoxia is avoided by preoxygenation and de-nitrogenation of the lungs prior to this process. A skilled anaesthetist is then required to complete this procedure before the patient experiences hypoxia. Despite these steps to prevent hypoxia, brief periods do occasionally occur during intubation although these are rapidly corrected by the anaesthetist using 100% oxygen following successful intubation. Some patient groups are at risk of hypoxia for a number of reasons and children are one of these due to smaller reserves of oxygen in the lungs. Disease processes and difficulty establishing a secure intubated airway (e.g. multiple attempts required ) can add to the risk of hypoxia in this group. The aim of this study is to examine the efficacy of nasal oxygen throughout direct laryngoscopy and intubation in children. By administering nasal oxygen (which avoids interference with the anaesthetist's view of the airway) we hope to avoid hypoxic events. This has potential benefits for children during resuscitation, intensive care, anaesthesia and emergency medicine. This study is a prospective , randomised control trial with the following null hypothesis: There is no statistical difference in the incidence, duration and severity of hypoxia (SpO2 < 94%) following direct laryngoscopy and endotracheal intubation between those children administered nasal oxygen and those not receiving nasal oxygen The patients will be closely monitored for signs of hypoxia using continuous pulse oximetry. Continual bispectral index monitoring will also be used to monitor for awareness.

Interventions

Standard Paediatric sized nasal prongs (Fisher-Paykel) as used throughout Starship Hospital , Auckland , will be applied to the patient after induction of anaesthesia. They are single use devices and will be applied to all patients in the study to ensure blinding is maintained. The group randomised to receive oxygen through the prongs will have these devices connected to a cylinder oxygen supply providing a flow of 5L/min , giving an fractional inspired oxygen concentration of 35%. These will

Standard Paediatric sized nasal prongs (Fisher-Paykel) as used throughout Starship Hospital , Auckland , will be applied to the patient after induction of anaesthesia. They are single use devices and will be applied to all patients in the study to ensure blinding is maintained. The group randomised to receive oxygen through the prongs will have these devices connected to a cylinder oxygen supply providing a flow of 5L/min , giving an fractional inspired oxygen concentration of 35%. These will remain in place until intubation has been confirmed through the use of end-tidal-carbon dioxide monitoring and then removed.

Sponsors

Dr Paul Baker
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
1 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

Children aged 1 year to 16 years ASA 1 and 2 only Requiring High Resolution CT of the Chest and Bronchoscopy (ie. require intubation)

Exclusion criteria

Critical illness ASA >3 Critical / anticipated difficult airway Ongoing need for supplemental oxygen pre-study BMI >30 Acute Respiratory Tract Infection Previous anaesthesia complication that prevents inclusion in the study as determined by anaesthetist Choanal atresia

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026