Effectiveness of Preoxygenation With Positive Airway Pressure: a Comparison of the Supine and 25° Head up Position

NCT ID: NCT03861949

Last Updated: 2019-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-15

Study Completion Date

2015-06-15

Brief Summary

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Several techniques such as positive airway pressure and head-up tilt during preoxygenation have shown to prolong non-hypoxic apnea period compared to conventional technique. However, uniform recommendations have not yet been made. Therefore, in the present study the investigators attempted to find out the effect of combination of 5 cmH2O CPAP and 25° head up position during preoxygenation.

Detailed Description

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In this study 60 non-obese healthy adult patients were divided into three groups; Group C receiving preoxygenation in conventional technique, Group S receiving preoxygenation with 5 cmH2O CPAP and Group H receiving preoxygenation in 25° head-up position with 5 cmH2O CPAP. After 3 min of preoxygenation, anesthesia was induced and trachea intubated. After confirming the tracheal intubation by direct visualization, all patients were left apneic in supine position with the tracheal tube exposed to atmosphere till the SpO2 dropped to 92%. The primary outcome compared between the groups was the non-hypoxic apnoeic period (time to fall SpO2 to 92%).

Conditions

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Intubation;Difficult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Conventional

preoxygenation done with 100% oxygen in supine position

Group Type NO_INTERVENTION

No interventions assigned to this group

Positive-pressure

preoxygenation done with 5 cmH2O CPAP (continuous positive airway pressure) in supine position with 100% oxygen

Group Type EXPERIMENTAL

5 cmH2O CPAP

Intervention Type OTHER

Head-up

preoxygenation done in 25 degree head-up position with 5 cmH2O CPAP with 100% oxygen

Group Type EXPERIMENTAL

5 cmH2O CPAP

Intervention Type OTHER

head-up position

Intervention Type OTHER

Interventions

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5 cmH2O CPAP

Intervention Type OTHER

head-up position

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* adult patients of ASA physical status I and II undergoing surgery under general anaesthesia

Exclusion Criteria

* anticipated difficult mask ventilation/ intubation
* individuals with significant cardiorespiratory or cerebrovascular disease
* pregnant ladies
* patient with history of epilepsy
* body mass index \>25 kg/m2
* hemoglobin \<8 gm/dL
* patients who were non-ambulant for \>24 h, having SpO2 \< 97% while breathing in room air
* phobia to facemask.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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B.P. Koirala Institute of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Yogesh Dhakal

Assistant Professor, Department of Anaesthesiology and Critical Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Balkrishna Bhattarai, Professor

Role: PRINCIPAL_INVESTIGATOR

B.P. Koirala Institute of Health Sciences

Sindhu Khatiwada, Professor

Role: PRINCIPAL_INVESTIGATOR

B.P. Koirala Institute of Health Sciences

Asish Subedi, Dr

Role: PRINCIPAL_INVESTIGATOR

B.P. Koirala Institute of Health Sciences

Other Identifiers

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IERB/205/014

Identifier Type: -

Identifier Source: org_study_id

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