A Quality Improvement Project - Peripartum Operating Room Leveling System

Cesarean Section Complications Clinical Trial

Official title:

A Multidisciplinary Approach to Peripartum Triaging of Patients to the Operating Room: A Quality Improvement Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552419
• Other study ID #: IRB00164177
• Status: Completed
• Start date: January 2017
• Est. completion date: July 1, 2020

Study information

• Verified date: August 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigators propose a four-category triaging system to delineate and facilitate the communication and action plan for all types of obstetric OR cases via a multidisciplinary approach. Investigators omitted ambiguous terms and developed an algorithm to categorize patients according to acuity and risk. Investigators' quality improvement intervention allows for rapidly changing circumstances and accounts for both obstetric and anesthetic considerations. Several metrics will be collected to evaluate this multidisciplinary quality improvement project, including maternal demographics, labor characteristics, and indication for surgical intervention. Additional data include level assigned, time of patient arrival in OR, type of surgery performed, and anesthetic delivered. Investigators will collect fetal delivery data, including Apgar scores and umbilical cord gases, as well as maternal delivery data, including estimated blood loss, time to uterine incision and delivery, and surgical complications.

Description:

At investigators' institution, a triage (or leveling) system for emergency surgeries in the general operating rooms (OR) exists with the goal of optimizing patient care and reducing morbidity and mortality. In the obstetric field, while medical terminology exists for these situations to delineate and convey the urgency of a particular peripartum situation, for example "stat, emergent, or urgent," it is generally acknowledged that this terminology is not universal and is somewhat ambiguous, causing confusion and unnecessary delays in patient care. Investigators propose a quality improvement project which will delineate terminology for obstetrical triaging to the OR and discuss metrics for evaluation of this quality improvement intervention. Investigators developed a multidisciplinary stratification system at investigators' institution to triage obstetric patients into a four-level system with clear guidelines for all OR cases. Investigators' categorization system accounted for maternal and fetal stability, indication for surgical intervention, role for obtaining additional studies, nil per os (NPO) status, and surgical and anesthetic concerns. Within each of the four classifications, investigators defined the expectations for each team member's role, including the obstetrician, anesthesiologist, charge nurse, nursing staff, neonatal intensive care unit (NICU) team, and the surgical and clinical technicians. Several metrics will be collected to evaluate this multidisciplinary quality improvement project, including maternal demographics, labor characteristics, and indication for surgical intervention. Additional data include level assigned, time of patient arrival in OR, type of surgery performed, and anesthetic delivered. Investigators will collect fetal delivery data, including Apgar scores and umbilical cord gases, as well as maternal delivery data, including estimated blood loss, time to uterine incision and delivery, and surgical complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1380
• Est. completion date: July 1, 2020
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Female of child-bearing age, requiring emergent procedure in operating room (including cesarean section, D&C, cerclage placement or removal)

Exclusion Criteria:

• Patients not requiring urgent surgical or invasive procedures

Related Conditions & MeSH terms

• Cesarean Section Complications
• Morbidity;Perinatal
• Pregnancy Complications

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Materno-fetal stability	This will be assessed by ICU admissions (days) and total length of hospital stay (days)	1 year
Primary	Indication for surgical intervention	surgery is required if patient has one or more of the following reasons: non-reassuring fetal tracing, umbilical cord prolapse, peripartum hemorrhage, or emergency dilation and curettage.	1 year
Primary	Role for obtaining additional studies	determine by the number of additional testing including Labs, imaging or EKG a patient required on top of standard studies.	1 year
Primary	nil per os (NPO) status	Time of last intake (fluid or solids) measured in hours and minutes	1 year
Primary	Surgical concerns	Concerns that may change our care, i.e. patient is full stomach but needs to have urgent surgery. This will be assessed via observation of patient condition and need of hospital care	1 year