Morbid ObesityNCT05021549
Apneic Oxygenation for Morbid Obese Parturient in cs
A study testing nasal prong in people with Morbid Obesity, run by Ain Shams University at 2 sites in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- nasal prong
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Sep 2021to 10 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Morbid obesity parturient defined as a body mass index (BMI) above 40 kg/m2.
- ASA physical status I-II
- Age above 18 years.
- Scheduled for elective caesarean section under general anesthesia.
Who cannot join
- Parturient of ASA physical status III or above.
- 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).
- Any contraindication for nasal prong use, for example, tumours, fractures or trauma.
- SpO2 ≤ 97% prior to preoxygenation.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Morbid Obesity
- Being tested
- nasal prong
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal prongDevice
apneic preoxygenation group (30 patients), will receive 10 L/ min of O2 via nasal prong during preintubation apnia
| Study group | Role | What they receive |
|---|---|---|
| nasal prong. | Active comparator | the apneic preoxygenation group (30 patients), will receive 10 L/ min of O2 via nasal prong. Receives: Device: nasal prong |
| conventional | No intervention | the conventional preoxygenation group (30 patients) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the lowest oxygen saturation recorded
percentage
Measured: during intubation procedure
Secondary outcomes (2)
rates of desaturation below SpO2 90%
percentage
Measured: during intubation procedure
rates of critical desaturation below SpO2 80%
percentage
Measured: during intubation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start15 Sep 2021
- Primary completion1 Apr 2022
- Study completion10 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wael Elswefi, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021549
- Sponsor's protocol ID
- morbid obese parturient
- Status last verified
- Jun 2022
- First submitted
- 20 Aug 2021
- Last updated
- 7 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD to be shared
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Apneic Oxygenation for Morbid Obese Parturient Performing Elective Caesarean Section Under General Anesthesia
- ClinicalTrials.gov ID
- NCT05021549
- Acronym / sponsor ID
- morbid obese parturient
- Conditions
- Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 10 Apr 2022 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| nasal prong. | Active comparator | Device: nasal prongthe apneic preoxygenation group (30 patients), will receive 10 L/ min of O2 via nasal prong. |
| conventional | No intervention | –the conventional preoxygenation group (30 patients) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Morbid obesity parturient defined as a body mass index (BMI) above 40 kg/m2.
- ASA physical status I-II
- Age above 18 years.
- Scheduled for elective caesarean section under general anesthesia.
Key exclusion criteria (4 listed)
- Parturient of ASA physical status III or above.
- 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).
- Any contraindication for nasal prong use, for example, tumours, fractures or trauma.
- SpO2 ≤ 97% prior to preoxygenation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasal prongapneic preoxygenation group (30 patients), will receive 10 L/ min of O2 via nasal prong during preintubation apnia | Device | nasal prong. |
Primary outcome
the lowest oxygen saturation recorded
Time frame: during intubation procedure
percentage
2 secondary outcomes
rates of desaturation below SpO2 90%
Time frame: during intubation procedure
rates of critical desaturation below SpO2 80%
Time frame: during intubation procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Individual participant dataSharing planned: Yes. all IPD to be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasal prong in people with Morbid Obesity, run by Ain Shams University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the lowest oxygen saturation recorded (time frame: during intubation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.