Apneic Oxygenation for Morbid Obese Parturient in cs

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Device: nasal prong

• Registration Number: NCT05021549
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-08-24
• Study First Posted: 2021-08-25
• Study Start: 2021-09-15
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-10
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-03
• Last Update Posted: 2022-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

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

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Exclusion Criteria

1. Parturient of ASA physical status III or above.
2. 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).
3. Any contraindication for nasal prong use, for example, tumours, fractures or trauma.
4. SpO2 ≤ 97% prior to preoxygenation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nasal prong.	nasal prong	the apneic preoxygenation group (30 patients), will receive 10 L/ min of O2 via nasal prong.

Primary Outcome Measures

Name	Time	Method
the lowest oxygen saturation recorded	during intubation procedure	percentage

Secondary Outcome Measures

Name	Time	Method
rates of desaturation below SpO2 90%	during intubation procedure	percentage
rates of critical desaturation below SpO2 80%	during intubation procedure	percentage

Trial Locations

Locations (2)

Faculty of medicine; 🇪🇬 Cairo, Egypt

Ain Shams university; 🇪🇬 Cairo, Egypt