Clinical trial NCT06030063: The Society for Obstetric Anesthesia and Perinatology Research Network General Anesthesia Registry
Official title: The Society for Obstetric Anesthesia and Perinatology Research Network General Anesthesia Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cesarean Delivery
General Anesthesia
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject population will reflect the diverse populations of the participating hospitals. The subject population will include pregnant women aged 15-55 years old who have a general anesthetic during their cesarean delivery. Non-English-speaking subjects will be included.

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.

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).

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Rates of General Anesthesia for Cesarean Delivery
timeFrame: Up to 5 years
measure: Univariate Association Between Facility Type and the Rate of General Anesthesia for Cesarean Delivery
timeFrame: Up to 5 years
measure: Univariate Association Between SOAP Center of Excellence Designation and the Rate of General Anesthesia for Cesarean Delivery
timeFrame: Up to 5 years
measure: Univariate Association Between Maternal Level of Care and the Rate of General Anesthesia for Cesarean Association
timeFrame: Up to 5 years
measure: Univariate Association Between Annual Live Births and the Rate of General Anesthesia for Cesarean Delivery
timeFrame: Up to 5 years
measure: Univariate Association Between Obstetric Anesthesiologist Coverage and the Rate of General Anesthesia for Cesarean Delivery
timeFrame: Up to 5 years
measure: Univariate Association Between Institutional Policies for Labor Epidural Management and the Rate of General Anesthesia for Cesarean Delivery
timeFrame: Up to 5 years
Secondary outcomes:
measure: Rates of Difficult Intubation Among Women Undergoing General Anesthesia for Cesarean Delivery
timeFrame: Up to 5 years
measure: Univariate Association Between Mallampati Score and the Risk of Difficult Intubation
timeFrame: Up to 5 years
measure: Univariate Association Between Neck Mobility and the Risk of Difficult Intubation
timeFrame: Up to 5 years
measure: Univariate Association Between Neck Circumference and the Risk of Difficult Intubation
timeFrame: Up to 5 years
measure: Univariate Association Between Neck Length and the Risk of Difficult Intubation
timeFrame: Up to 5 years
measure: Univariate Association Between Thyromental Distance and the Risk of Difficult Intubation
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas
state: Arkansas
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Arvada
country: United States
facility: University of Colorado Hospital
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Boise
country: United States
facility: St Lukes Anesthesia Associates of Boise
state: Idaho
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Health System
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Mercy Hospital St. Louis
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Stony Brook
country: United States
facility: Renaissance School of Medicine Stony Brook University
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University o Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Ohio State University/Wexner Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas-Houston
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: New Westminster
country: Canada
facility: Royal Columbian Hospital & University of British Columbia
Study officials:
affiliation: Yale Univesrity
name: Lisa Leffert, MD
role: PRINCIPAL_INVESTIGATOR
References: