The Society for Obstetric Anesthesia and Perinatology Research Network General Anesthesia Registry

• Sponsor: Yale University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06030063
• Collaborator: (none)
• Enrollment: 5,000
• Anticipated Duration (Months): 72

Study Details

Study Description

Brief Summary

The SOAP registry is a prospective, multicenter, electronic registry. The goal is to investigate the indications, mode of airway management, predisposing factors, and obstetric and anesthetic outcomes of pregnant patients who receive general anesthesia for cesarean delivery.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Delivery; General Anesthesia

Detailed Description

This is a central repository with data from 25-40 participating SOAP institutions/hospitals.

The primary and secondary aims of this study are as follows:

1. To determine the institutional factors associated with rates of general anesthesia for cesarean delivery

2. To perform a descriptive analysis of characteristics of general anesthesia for cesarean delivery cases

3. To determine maternal and anesthetic predictors of difficult intubation

Data will be collected from each participating SOAP institution. Institutional data will include information on the characteristics of the institution such as maternal level of care, numbers of lives birth, staffing models, etc. This data will be collected prior to subjects being enrolled into the registry and again at the registry closure to look at intuitional changes over time.

Inclusion into the registry is based on the following criteria:

1. Pregnant women who have had a general anesthetic for Cesarean delivery

2. 15-55 years old

The general anesthesia registry will collect data on subject demographics in a deidentified manner, including characteristics of the birth and delivery, gestational age, maternal morbidities, and anesthetic management.

The granular detail requested in the registry database will help to better understand the nuances of how and why decisions are made about proceeding with general anesthesia in these cases, and once done, how to implement this clinical course. As not all of these data points are routinely recorded in the medical record, optimal data capture requires the treating anesthesiologist to complete the registry entry as soon as possible after conclusion of patient care.

Data will be collected for approximately 5 years and maintained indefinitely. Data is entered into a Yale REDCap registry and will not contain subject identifiers. An estimated 5000 subjects will be enrolled into the data repository. This is based on a published report of 45 institutions' data investigating a subtopic of this question (15 years yielding 15,000 general anesthetics).

Study Design

• Study Type: Observational
• Anticipated Enrollment: 5000 participants
• Observational Model: Ecologic or Community
• Time Perspective: Retrospective
• Official Title: The Society for Obstetric Anesthesia and Perinatology Research Network General Anesthesia Registry
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2028
• Anticipated Study Completion Date: Sep 1, 2029

Outcome Measures

Primary Outcome Measures

1. Rates of General Anesthesia for Cesarean Delivery [Up to 5 years]

   The rates of general anesthesia for cesarean delivery among the institutions in the cohort will be assessed. Descriptive analyses of etiologies of and management of general anesthetics for cesarean delivery will also be performed.

2. Univariate Association Between Facility Type and the Rate of General Anesthesia for Cesarean Delivery [Up to 5 years]

   The association between facility type- non-academic affiliated private vs. academic affiliated private vs. military vs. academic (reference)- with a difference in rates of general anesthesia for cesarean delivery will be assessed.

3. Univariate Association Between SOAP Center of Excellence Designation and the Rate of General Anesthesia for Cesarean Delivery [Up to 5 years]

   The association between SOAP center of excellence designation- yes (reference) vs. no- with a difference in rates of general anesthesia for cesarean delivery will be assessed.

4. Univariate Association Between Maternal Level of Care and the Rate of General Anesthesia for Cesarean Association [Up to 5 years]

   The association between maternal level of care- I vs. II vs. III vs. IV (reference)- with a difference in rates of general anesthesia for cesarean delivery will be assessed.

5. Univariate Association Between Annual Live Births and the Rate of General Anesthesia for Cesarean Delivery [Up to 5 years]

   The association between increased numbers of annual live births (continuous variable) and a difference in rates of general anesthesia for cesarean delivery will be assessed.

6. Univariate Association Between Obstetric Anesthesiologist Coverage and the Rate of General Anesthesia for Cesarean Delivery [Up to 5 years]

   The association between increased rates of labor and delivery floor coverage by obstetric anesthesiologists (continuous variable) and a difference in rates of general anesthesia for cesarean delivery will be assessed.

7. Univariate Association Between Institutional Policies for Labor Epidural Management and the Rate of General Anesthesia for Cesarean Delivery [Up to 5 years]

   The association between the presence of institutional policies for labor epidural management- yes (reference) vs. no- and a difference in rates of general anesthesia for cesarean delivery will be assessed.

Secondary Outcome Measures

1. Rates of Difficult Intubation Among Women Undergoing General Anesthesia for Cesarean Delivery [Up to 5 years]

   Among the cohort of general anesthetics for cesarean delivery, the incidence of difficult intubation will be determined.

2. Univariate Association Between Mallampati Score and the Risk of Difficult Intubation [Up to 5 years]

   The association between increased Mallampati score- I or II (reference) vs. III vs. IV- and a difference in risk of difficult intubation will be assessed.

3. Univariate Association Between Neck Mobility and the Risk of Difficult Intubation [Up to 5 years]

   The association between neck mobility- full (reference) vs. limited vs. poor and a difference in risk of difficult intubation will be assessed.

4. Univariate Association Between Neck Circumference and the Risk of Difficult Intubation [Up to 5 years]

   The association between neck circumference- thin or average (reference) vs. thick and a difference in risk of difficult intubation will be assessed.

5. Univariate Association Between Neck Length and the Risk of Difficult Intubation [Up to 5 years]

   The association between neck length- long or average (reference) vs. short and a difference in risk of difficult intubation will be assessed.

6. Univariate Association Between Thyromental Distance and the Risk of Difficult Intubation [Up to 5 years]

   The association between thyromental distance- >6.5cm (reference) vs. 3.5-6.5cm vs. <3.5cm and a difference in risk of difficult intubation will be assessed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

-Pregnant women aged 15-55 who have had a general anesthetic for Cesarean delivery

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Yale University

Investigators

• Principal Investigator: Lisa Leffert, MD, Yale Univesrity

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT06030063
• Other Study ID Numbers: 2000033638
• First Posted: Sep 8, 2023
• Last Update Posted: Sep 13, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 13, 2023