Apneic Oxygenation for Morbid Obese Parturient in cs

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05021549
• Other study ID #: morbid obese parturient
• Status: Completed
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: April 10, 2022

Study information

• Verified date: June 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 10, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams university	Cairo
Egypt	Faculty of medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the lowest oxygen saturation recorded	percentage	during intubation procedure
Secondary	rates of desaturation below SpO2 90%	percentage	during intubation procedure
Secondary	rates of critical desaturation below SpO2 80%	percentage	during intubation procedure