Apneic Oxygenation for Morbid Obese Parturient in cs

NCT ID: NCT05021549

Last Updated: 2022-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2022-04-10

Brief Summary

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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

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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.

Conditions

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Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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nasal prong.

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

Group Type ACTIVE_COMPARATOR

nasal prong

Intervention Type DEVICE

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

conventional

the conventional preoxygenation group (30 patients)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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nasal prong

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Wael Elswefi

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams university

Cairo, , Egypt

Site Status

Faculty of medicine

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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morbid obese parturient

Identifier Type: -

Identifier Source: org_study_id

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