Pregnancy ComplicationsNCT03552419
A Quality Improvement Project - Peripartum Operating Room Leveling System
An observational study of Pregnancy Complications and Cesarean Section Complications, run by Johns Hopkins University.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy Complications, Cesarean Section Complications, Morbidity;Perinatal
- How many people
- 1,380 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Female of child-bearing age, requiring emergent procedure in operating room (including cesarean section, D\&C, cerclage placement or removal)
Who cannot join
- Patients not requiring urgent surgical or invasive procedures
About this study
Official title: A Multidisciplinary Approach to Peripartum Triaging of Patients to the Operating Room: A Quality Improvement Project
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.
Read the detailed 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.
- Keywords
- Operating room leveling, Obstetric anesthesia, Time to incision
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Materno-fetal stability
This will be assessed by ICU admissions (days) and total length of hospital stay (days)
Measured: 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.
Measured: 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.
Measured: 1 year
nil per os (NPO) status
Time of last intake (fluid or solids) measured in hours and minutes
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study startJan 2017
- Primary completionJul 2019
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamie D Murphy, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552419
- Sponsor's protocol ID
- IRB00164177
- Status last verified
- Aug 2020
- First submitted
- 2 May 2018
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidisciplinary Approach to Peripartum Triaging of Patients to the Operating Room: A Quality Improvement Project
- ClinicalTrials.gov ID
- NCT03552419
- Acronym / sponsor ID
- IRB00164177
- Keywords
- Operating room leveling, Obstetric anesthesia, Time to incision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,380 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Female of child-bearing age, requiring emergent procedure in operating room (including cesarean section, D\&C, cerclage placement or removal)
Key exclusion criteria (1 listed)
- Patients not requiring urgent surgical or invasive procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Materno-fetal stability
Time frame: 1 year
This will be assessed by ICU admissions (days) and total length of hospital stay (days)
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.
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.
nil per os (NPO) status
Time frame: 1 year
Time of last intake (fluid or solids) measured in hours and minutes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie D Murphy, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complications and Cesarean Section Complications, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Materno-fetal stability (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.