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CompletedNCT05021549Updated Jun 7, 2022

Apneic Oxygenation for Morbid Obese Parturient in cs

An interventional study of nasal prong in Morbid Obesity, sponsored by Ain Shams University. Completed at 2 sites in Egypt. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-07.

Sponsored by Ain Shams University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Morbid Obesity

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03

In context

Obesity, Morbid

922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 590 interventional studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    nasal prong.

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

    Device: nasal prong

  • No intervention
    conventional

    the conventional preoxygenation group (30 patients)

Interventions

  • Devicenasal prong

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

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What researchers measure

Primary outcomes

  1. the lowest oxygen saturation recorded

    percentage

    Time frame: during intubation procedure

Secondary outcomes

  1. rates of desaturation below SpO2 90%

    percentage

    Time frame: during intubation procedure

  2. rates of critical desaturation below SpO2 80%

    percentage

    Time frame: during intubation procedure

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Study locations

2 sites
  • Ain Shams university
    Cairo, 11591, Egypt
  • Faculty of medicine
    Cairo, 11591, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — all IPD to be shared

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05021549
Lead sponsor
Ain Shams University
Responsible party
Wael Elswefi (lecturer, Ain Shams University) — Principal investigator
First posted
Aug 25, 2021
Start date
Sep 15, 2021
Primary completion
Apr 1, 2022
Completion
Apr 10, 2022
Last update
Jun 7, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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