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

NCT03861949 | Completed DMC

• 1 other identifier: IERB/205/014
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intubation;Difficult

Keywords

apnea; CPAP; Preoxygenation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Comparison of pH at different time points

  2 hours

• Comparison of PaO2 at different time points

  2 hours

• Comparison of PaCO2 at different time points

  2 hours

Study Arms (3)

Conventional

NO INTERVENTION

preoxygenation done with 100% oxygen in supine position

Positive-pressure

EXPERIMENTAL

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

Other: 5 cmH2O CPAP

Head-up

EXPERIMENTAL

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

Other: 5 cmH2O CPAP; Other: head-up position

Interventions

5 cmH2O CPAP OTHER

Head-up; Positive-pressure

head-up position OTHER

Head-up

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

MeSH Terms

Conditions

Apnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anaesthesiology and Critical Care

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 5, 2019
• Study Start: June 15, 2014
• Primary Completion: June 15, 2015
• Study Completion: June 15, 2015
• Last Updated: March 6, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share