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Completed

NCT Number: NCT03552419

A Quality Improvement Project - Peripartum Operating Room Leveling System

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Materno-fetal stability

    Time frame: 1 year

    This will be assessed by ICU admissions (days) and total length of hospital stay (days)

  2. Indication for surgical intervention

    Time frame: 1 year

    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.

  3. Role for obtaining additional studies

    Time frame: 1 year

    determine by the number of additional testing including Labs, imaging or EKG a patient required on top of standard studies.

  4. nil per os (NPO) status

    Time frame: 1 year

    Time of last intake (fluid or solids) measured in hours and minutes

  5. Surgical concerns

    Time frame: 1 year

    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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jun 11, 2018
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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