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

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06030063
• Other study ID #: 2000033638
• Status: Recruiting
• Start date: February 22, 2024
• Est. completion date: September 2029

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Lisa Leffert, MD
• Phone: (203)785-4304
• Email: lisa.leffert[@]yale.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: September 2029
• Est. primary completion date: September 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 55 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Cesarean Delivery
• General Anesthesia

Locations

Country	Name	City	State
Canada	Royal Columbian Hospital & University of British Columbia	New Westminster
United States	Albany Medical Center	Albany	New York
United States	University of Colorado Hospital	Arvada	Colorado
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston Medical Center	Boston	Massachusetts
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University o Cincinnati	Cincinnati	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida	Gainesville	Florida
United States	Indiana University	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	Northwell Health	Manhasset	New York
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	Oregon Health & Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California San Francisco	San Francisco	California
United States	Stanford University	Stanford	California
United States	Renaissance School of Medicine Stony Brook University	Stony Brook	New York
United States	Baylor Scott & White Medical Center	Temple	Texas
United States	Atrium Health Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of General Anesthesia for Cesarean Delivery	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.	Up to 5 years
Primary	Univariate Association Between Facility Type and the Rate of General Anesthesia for Cesarean Delivery	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.	Up to 5 years
Primary	Univariate Association Between SOAP Center of Excellence Designation and the Rate of General Anesthesia for Cesarean Delivery	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.	Up to 5 years
Primary	Univariate Association Between Maternal Level of Care and the Rate of General Anesthesia for Cesarean Association	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.	Up to 5 years
Primary	Univariate Association Between Annual Live Births and the Rate of General Anesthesia for Cesarean Delivery	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.	Up to 5 years
Primary	Univariate Association Between Obstetric Anesthesiologist Coverage and the Rate of General Anesthesia for Cesarean Delivery	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.	Up to 5 years
Primary	Univariate Association Between Institutional Policies for Labor Epidural Management and the Rate of General Anesthesia for Cesarean Delivery	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.	Up to 5 years
Secondary	Rates of Difficult Intubation Among Women Undergoing General Anesthesia for Cesarean Delivery	Among the cohort of general anesthetics for cesarean delivery, the incidence of difficult intubation will be determined.	Up to 5 years
Secondary	Univariate Association Between Mallampati Score and the Risk of Difficult Intubation	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.	Up to 5 years
Secondary	Univariate Association Between Neck Mobility and the Risk of Difficult Intubation	The association between neck mobility- full (reference) vs. limited vs. poor and a difference in risk of difficult intubation will be assessed.	Up to 5 years
Secondary	Univariate Association Between Neck Circumference and the Risk of Difficult Intubation	The association between neck circumference- thin or average (reference) vs. thick and a difference in risk of difficult intubation will be assessed.	Up to 5 years
Secondary	Univariate Association Between Neck Length and the Risk of Difficult Intubation	The association between neck length- long or average (reference) vs. short and a difference in risk of difficult intubation will be assessed.	Up to 5 years
Secondary	Univariate Association Between Thyromental Distance and the Risk of Difficult Intubation	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.	Up to 5 years