ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000697785

Ethics application status

Approved

Date submitted

20/06/2013

Date registered

26/06/2013

Date last updated

26/06/2013

Type of registration

Prospectively registered

Titles & IDs

Public title

Measuring the benefit of buccal oxygenation in the apnoeic patient

Scientific title

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

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Desaturation during laryngoscopy (anaesthesia)

Condition category

Condition code

Anaesthesiology

Anaesthetics

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Other

Comparator / control treatment

Oxygen 10 l/min versus no flow

Control group

Active

Outcomes

Primary outcome [1]

Desaturation (SpO2 to 95%) monitored with pulse oximetry

Timepoint [1]

Time to reach SpO2 95% in seconds or 10 min if no desaturation occurs

Secondary outcome [1]

NIL

Timepoint [1]

NIL

Eligibility

Key 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

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

computerised sequence generation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

A power analysis was performed to determine the number of subjects required for the study.
We expected a minimum of 60 seconds difference between the SpO2>95% times of the two groups. Based on this assumption and Type I and Type II errors of 5% and 20%, respectively(power 80%), 15 patients per group were required to prove the hypothesis.
To account for withdrawasls and fall-outs n=20 will be recruited for each group.
All continuous data were identified as nonparameteric and the Mann Whitney U test was used to determine statistical significance between groups. Pearson's chi-squared test and Fisher's exact test will be used to show significant differences between the two groups in frequency data. Statistical analysis(SPSS15.0 for Windows Software) will be used to perform the statistical analysis.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

27/06/2013

Actual

Date of last participant enrolment

Anticipated

20/06/2014

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Royal Perth Hospital - Perth

Recruitment postcode(s) [1]

6847 - Perth

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

Department of Anaesthesia, Royal Perth Hospital

Address

Wellington Street Campus
BOX X2213, GPO
Perth 6847
Western Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee

Ethics committee address [1]

Level 5 Colonial House, Royal Perth Hospital, GPO Box X2213 Perth WA 6001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/06/2013

Ethics approval number [1]

REG 13-050

Summary

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.

Trial website

Trial related presentations / publications

1. Altermatt FR, Munoz HR, Delfino AE, Cortinez LI. Pre-oxygenation in the obese patient: effects of position on tolerance to apnoea. Br J Anaesth 2005;95:706-9.
2. Gander S, Frascarolo P, Suter M, Spahn DR, Magnusson L. Positive end-expiratory pressure during induction of general anesthesia increases duration of nonhypoxic apnea in morbidly obese patients. Anesth Analg 2005;100:580-4.
3. Dixon BJ, Dixon JB, Carden JR, Burn AJ, Schachter LM, Playfair JM, Laurie CP, O'Brien PE. Preoxygenation is more effective in the 25 degrees head-up position than in the supine position in severely obese patients: a randomized controlled study. Anesthesiology 2005;102:1110-5; discussion 5A.
4. Jense HG, Dubin SA, Silverstein PI, O'Leary-Escolas U. Effect of obesity on safe duration of apnea in anesthetized humans. Anesth Analg 1991;72:89-93.
5. Teller LE, Alexander CM, Frumin MJ, Gross JB. Pharyngeal insufflation of oxygen prevents arterial desaturation during apnea. Anesthesiology 1988;69:980-2.
6. Baraka AS, Taha SK, Siddik-Sayyid SM, Kanazi GE, El-Khatib MF, Dagher CM, Chehade JM, Abdallah FW, Hajj RE. Supplementation of pre-oxygenation in morbidly obese patients using nasopharyngeal oxygen insufflation. Anaesthesia 2007;62:769-73.
7. Ramachandran SK, Cosnowski A, Shanks A, Turner CR. Apneic oxygenation during prolonged laryngoscopy in obese patients: a randomized, controlled trial of nasal oxygen administration. J Clin Anesth;22:164-8.

Public notes

Contacts

Principal investigator

Name

Dr Andrew Heard

Address

Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street Campus
BOX X2213, GPO, Perth 6487
Western Australia

Country

Australia

Phone

+61 8 92241037

Fax

+61 8 92241111

andrew.heard@health.wa.gov.au

Contact person for public queries

Name

Andrew Heard

Address

Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street Campus
BOX X2213, GPO, Perth 6487
Western Australia

Country

Australia

Phone

+61 8 92241037

Fax

+61 8 92241111

andrew.heard@health.wa.gov.au

Contact person for scientific queries

Name

Andrew Heard

Address

Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street Campus
BOX X2213, GPO, Perth 6487
Western Australia

Country

Australia

Phone

+61 8 92241037

Fax

+61 8 92241111

andrew.heard@health.wa.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Apneic oxygenation during prolonged laryngoscopy in obese patients: A randomized, controlled trial of buccal RAE tube oxygen administration.	2017	https://dx.doi.org/10.1213/ANE.0000000000001564

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically