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Measuring the benefit of buccal oxygenation in the apnoeic patient

Apneic oxygenation during prolonged laryngoscopy in obese patients: a randomized, controlled trial of buccal RAE tube oxygen administration

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000697785
Enrollment
40
Registered
2013-06-26
Start date
2013-06-27
Completion date
2014-06-20
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

Patients having operations under general anaesthesia will be asleep for the duration of the procedure and their own breathing efforts will be reduced by the anaesthetic drugs. The anaesthetist will support the patients breathing and will place a breathing tube into his/her windpipe as soon as the patient have drifted off to sleep. Normally, the anaesthetist discontinues the administration of oxygen during this manoeuvre as it usually takes only a short time to insert the breathing tube. We believe that continuing the supply of oxygen through a small tube into the inside of the patients cheek at this stage will keep the body oxygen levels higher than they would be otherwise. This is especially important for patients who are overweight or pregnant and also in children as their oxygen reserves exhaust more quickly. Computer programs and our understanding of the biology of people have suggested this would be the case. However, we do not have proof of this at present.

Interventions

In theatre patients will receive a standardised induction of anesthesia . For the the laryngoscopy (procedure to visualise the vocal cords and therefore entrance into the windpipe) and intubation (placement of the endotracheal tube into the windpipe) in the anaesthetised and apnoeic patient, the oxygen administration is traditionally interrupted for a short time until the breathing tube is connected to the ventilator. In this study the patients are either receiving additional oxygen (10 l/min fl

In theatre patients will receive a standardised induction of anesthesia . For the the laryngoscopy (procedure to visualise the vocal cords and therefore entrance into the windpipe) and intubation (placement of the endotracheal tube into the windpipe) in the anaesthetised and apnoeic patient, the oxygen administration is traditionally interrupted for a short time until the breathing tube is connected to the ventilator. In this study the patients are either receiving additional oxygen (10 l/min flow) via a 3.5 mm RAE tube in the buccal space during laryngascopy or no additional oxygen. During artificially prolonged laryngoscopy the saturation will be recorded for a maximum of 10 min or until the saturation starts to drop to 95%. The patient will then be intubated and anaesthesia will be continued as per routine.

Sponsors

Department of Anaesthesia, Royal Perth Hospital
Lead SponsorHospital

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
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1) Adult patients requiring general anaesthesia with endotrachel intubation for scheduled surgery 2) BMI 30-40 3) ASA1-2 4) Agree to and capapble of understanding and signing the consent form

Exclusion criteria

Study population - Exclusion criteria: 1) Age < 18 2) Chronic Respiratory Disease 3 ) SpO2 <98% despite preoxygenation with 100% O2 4) History of difficult intubation or anticipated difficult intubation 5) Uncontrolled hypertension 6) Ischaemic Heart disease or congestive Heart Failure 7) Increased intracranial pressure 7) Gastroesophageal reflux disease 8) Non fasting patients 9) Emergency procedures

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026