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Completed

NCT Number: NCT05021549

Apneic Oxygenation for Morbid Obese Parturient in cs

The aim of this study is to compare the effect of apneic preoxygenation to conventional preoxygenation on the oxygen desaturation in morbid obese parturient performing elective caesarean section under general anesthesia.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams university, Cairo, Egypt

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About this study

Anesthetic management of the obese parturient is challenging. Both pregnancy and obesity are risk factors for a difficult airway and anesthesia-related maternal mortality. There is increased risk of difficult intubation associated with an increased difficultly in mask ventilation and increased risk of accelerated desaturation during apnea.

The use of apneic oxygenation for the optimization of peri-intubation conditions is a promising means of preventing hypoxemia.

Despite the recommendation of the use of nasal prongs to insufflate oxygen at flows of 5 L/min to 15 L/min during the apneic period randomized controlled trial is still not available in the morbidly obese parturient.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Morbid obesity parturient defined as a body mass index (BMI) above 40 kg/m2.
  • ASA physical status I-II
  • Age above 18 years.
  • Scheduled for elective caesarean section under general anesthesia.

Exclusion criteria

  • Parturient of ASA physical status III or above.
  • Suspected or known difficult airway (Mallampati class > 2, reduced neck movement, reduced mouth opening, or Cormack-Lehane grade 4 recorded during a previous intubation procedure).
  • Any contraindication for nasal prong use, for example, tumours, fractures or trauma.
  • SpO2 ≤ 97% prior to preoxygenation.

Treatment and study plan

nasal prong

Device

apneic preoxygenation group (30 patients), will receive 10 L/ min of O2 via nasal prong during preintubation apnia

Primary outcomes

  1. the lowest oxygen saturation recorded

    Time frame: during intubation procedure

    percentage

Secondary outcomes

  1. rates of desaturation below SpO2 90%

    Time frame: during intubation procedure

    percentage

  2. rates of critical desaturation below SpO2 80%

    Time frame: during intubation procedure

    percentage

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Effectiveness of Apneic Oxygenation for Morbid Obese Parturient Performing Elective Caesarean Section Under General Anesthesia

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 25, 2021
Registry last updated
Jun 7, 2022

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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