The Society for Obstetric Anesthesia and Perinatology Research Network General Anesthesia Registry
- Conditions
- Cesarean DeliveryGeneral Anesthesia
- Registration Number
- NCT06030063
- Lead Sponsor
- Yale University
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 5000
-Pregnant women aged 15-55 who have had a general anesthetic for Cesarean delivery
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
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.
Trial Locations
- Locations (35)
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
University of Arkansas
🇺🇸Little Rock, Arkansas, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Stanford University
🇺🇸Stanford, California, United States
University of Colorado Hospital
🇺🇸Arvada, Colorado, United States
Yale University
🇺🇸New Haven, Connecticut, United States
University of Florida
🇺🇸Gainesville, Florida, United States
St Lukes Anesthesia Associates of Boise
🇺🇸Boise, Idaho, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Kansas Health System
🇺🇸Kansas City, Kansas, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Mercy Hospital St. Louis
🇺🇸Saint Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Northwell Health
🇺🇸Manhasset, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Renaissance School of Medicine Stony Brook University
🇺🇸Stony Brook, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
University o Cincinnati
🇺🇸Cincinnati, Ohio, United States
Ohio State University/Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Texas-Houston
🇺🇸Houston, Texas, United States
Baylor Scott & White Medical Center
🇺🇸Temple, Texas, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Royal Columbian Hospital & University of British Columbia
🇨🇦New Westminster, Canada