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

Intubation;Difficult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03861949
• Other study ID #: IERB/205/014
• Status: Completed
• Phase: N/A
• Start date: June 15, 2014
• Est. completion date: June 15, 2015

Study information

• Verified date: March 2019
• Source: B.P. Koirala Institute of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 15, 2015
• Est. primary completion date: June 15, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intubation;Difficult

Intervention

Other:
• 5 cmH2O CPAP

• head-up position

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
B.P. Koirala Institute of Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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