Apneic Oxygenation for Morbid Obese Parturient in cs

June 3, 2022 updated by: Wael Elswefi, Ain Shams University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11591
        • Ain Shams University
      • Cairo, Egypt, 11591
        • Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: nasal prong.
the apneic preoxygenation group (30 patients), will receive 10 L/ min of O2 via nasal prong.
Device: nasal prong
apneic preoxygenation group (30 patients), will receive 10 L/ min of O2 via nasal prong during preintubation apnia
No Intervention: conventional
the conventional preoxygenation group (30 patients)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the lowest oxygen saturation recorded
Time Frame: during intubation procedure
percentage
during intubation procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rates of desaturation below SpO2 90%
Time Frame: during intubation procedure
percentage
during intubation procedure
rates of critical desaturation below SpO2 80%
Time Frame: during intubation procedure
percentage
during intubation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 10, 2022

Study Registration Dates

First Submitted

August 20, 2021

First Submitted That Met QC Criteria

August 24, 2021

First Posted (Actual)

August 25, 2021

Study Record Updates

Last Update Posted (Actual)

June 7, 2022

Last Update Submitted That Met QC Criteria

June 3, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • morbid obese parturient

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all IPD to be shared

IPD Sharing Time Frame

after finishing the study

IPD Sharing Access Criteria

clinicaltrial web site

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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