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NCT06030063 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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:

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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

Study Design

Related Conditions & MeSH terms

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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
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