A Quality Improvement Project - Peripartum Operating Room Leveling System

NCT03552419 | Completed DMC

• 1 other identifier: IRB00164177
• Study Type: observational
• Target: 1,380
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pregnancy Complications; Cesarean Section Complications; Morbidity;Perinatal

Keywords

Operating room leveling; Obstetric anesthesia; Time to incision

Outcome Measures

Primary Outcomes (5)

• Materno-fetal stability

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

  1 year

• 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

• 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

• nil per os (NPO) status

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

  1 year

• 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

Study Arms (4)

Level Red

A level red refers to a case with an immediate threat to the life of the fetus or mother and may not be delayed under any circumstance.

Level Orange

A level orange case requires the patient to arrive in the OR within 30 minutes from the time of decision with the approximate estimated time of arrival determined by the obstetrician.

Level Yellow

A level yellow case requires operative intervention, but there is no maternal and/or fetal compromise at the time of evaluation. Timing to the OR is agreed upon by both the anesthesiology and obstetrical providers. The case may be delayed if a level red or orange case is identified. Possible

Level Green

A level green case is most dependent on the acuity of the OR suite and unit. The patient and/or fetus are stable with no threat to the health of either.

Eligibility Criteria

• Gender Eligibility Details: Female of child-bearing age
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In obstetrics, triage assessment incorporates both maternal and fetal considerations. Priority is given to situations with obvious threat to life to the mother or to the fetus. 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. Furthermore, simply classifying the need for cesarean into a single "emergency" category is insufficient as varying levels of "emergencies" exist. In the modern-day era, the obstetrical decision for surgical intervention prompts the mobilization of a team of providers, including the obstetrician, anesthesiologist, nursing and surgical technicians, and supporting OR staff. Thus, effective communication among team members is essential.

You may qualify if:

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

You may not qualify if:

• Patients not requiring urgent surgical or invasive procedures

Sponsors & Collaborators

• Johns Hopkins University: lead

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jamie D Murphy, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: June 11, 2018
• Study Start: January 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2020
• Last Updated: May 6, 2023

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share