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

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

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.

Study Overview

• Status: Completed
• Conditions: Intubation;Difficult
• Intervention / Treatment: Other: 5 cmH2O CPAP; Other: head-up position

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
non-hypoxic apnoeic period (time to fall SpO2 to 92%)	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%.	2 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): June 15, 2014
• Primary Completion (Actual): June 15, 2015
• Study Completion (Actual): June 15, 2015

Study Registration Dates

• First Submitted: March 1, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 6, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: apnea; CPAP; Preoxygenation
• Other Study ID Numbers: IERB/205/014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No