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NCT Number: NCT03861949

Effectiveness of Preoxygenation With Positive Airway Pressure: 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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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%).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5 cmH2O CPAP

Other

head-up position

Other

Primary outcomes

  1. non-hypoxic apnoeic period (time to fall SpO2 to 92%)

    Time frame: 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 outcomes

  1. Comparison of pH at different time points

    Time frame: 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.

  2. Comparison of PaO2 at different time points

    Time frame: 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.

  3. Comparison of PaCO2 at different time points

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

B.P. Koirala Institute of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 5, 2019
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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