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

Sponsor

B.P. Koirala Institute of Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT03861949

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Intubation;Difficult	Other: 5 cmH2O CPAP Other: head-up position	N/A

Detailed Description

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%).

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Effectiveness of Preoxygenation With Positive Airway Pressure in Non-obese Healthy Patient: a Comparison of the Supine and 25° Head up Position

Actual Study Start Date :

Jun 15, 2014

Actual Primary Completion Date :

Jun 15, 2015

Actual Study Completion Date :

Jun 15, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Conventional preoxygenation done with 100% oxygen in supine position
Experimental: Positive-pressure preoxygenation done with 5 cmH2O CPAP (continuous positive airway pressure) in supine position with 100% oxygen	Other: 5 cmH2O CPAP
Experimental: Head-up preoxygenation done in 25 degree head-up position with 5 cmH2O CPAP with 100% oxygen	Other: 5 cmH2O CPAP Other: head-up position

Arm

Intervention/Treatment

No Intervention: Conventional

preoxygenation done with 100% oxygen in supine position

Experimental: Positive-pressure

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

Other: 5 cmH2O CPAP

Experimental: Head-up

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

Other: 5 cmH2O CPAP

Other: head-up position

Outcome Measures

Primary Outcome Measures

non-hypoxic apnoeic period (time to fall SpO2 to 92%) [2 hours]
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%.

Secondary Outcome Measures

Comparison of pH at different time points [2 hours]
Arterial blood gas analysis was done and the pH at the start of preoxygenation, after preoxygenation and at desaturation (SpO2= 92%) were compared.
Comparison of PaO2 at different time points [2 hours]
Arterial blood gas analysis was done and the PaO2 at the start of preoxygenation, after preoxygenation and at desaturation (SpO2= 92%) were compared.
Comparison of PaCO2 at different time points [2 hours]
Arterial blood gas analysis was done and the PaCO2 at the start of preoxygenation, after preoxygenation and at desaturation (SpO2= 92%) were compared.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

B.P. Koirala Institute of Health Sciences

Investigators

Principal Investigator: Balkrishna Bhattarai, Professor, B.P. Koirala Institute of Health Sciences
Principal Investigator: Sindhu Khatiwada, Professor, B.P. Koirala Institute of Health Sciences
Principal Investigator: Asish Subedi, Dr, B.P. Koirala Institute of Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yogesh Dhakal, Assistant Professor, Department of Anaesthesiology and Critical Care, B.P. Koirala Institute of Health Sciences

ClinicalTrials.gov Identifier:

NCT03861949

Other Study ID Numbers:

IERB/205/014

First Posted:

Mar 5, 2019

Last Update Posted:

Mar 6, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yogesh Dhakal, Assistant Professor, Department of Anaesthesiology and Critical Care, B.P. Koirala Institute of Health Sciences

apnea

CPAP

Preoxygenation

Study Results

No Results Posted as of Mar 6, 2019