Obstetric Anesthesia ProblemsNCT04398602
Leader and Team Performance During PPH Simulated Scenario
An observational study of Obstetric Anesthesia Problems, run by Capogna Giorgio at 1 site in Italy.
Trial summary
The primary aim of this study is the progress of the performance of the leader and of the team for the postpartum hemorrhage (PPH) before and after four high-fidelity standardized scenarios of severe PPH (1500 mL blood loss) due to refractory uterine atony with anesthesia trainees. Read more about this study
- Who is it for?
- Ages 25 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstetric Anesthesia Problems
- What is being tested?
- behavior of the leader
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2020to 30 Apr 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 25 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: anesthesia trainees
Who may be able to join
- anesthesia trainee
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leader and Team Performance During PPH Simulated Scenario: a Comparison Between Self- and Expert's Assessment
The primary aim of this study is the progress of the performance of the leader and of the team for the postpartum hemorrhage (PPH) before and after four high-fidelity standardized scenarios of severe PPH (1500 mL blood loss) due to refractory uterine atony with anesthesia trainees.
Read the detailed description
8 teams were studied: each team consisted of six participants, all anesthesia trainees, who were given the following roles for the scenario: senior anesthesiologist, anesthesia trainee, obstetrician, midwife, and nurse. The teams encountered the same scenario of a patient with atonic PPH following vaginal delivery. The scenario was repeated four times and the assigned roles to the participants, except that one of the senior anesthesiologists, rotated every each scenario.For the design of the PPH checklist, the authors reviewed PPH guidelines from recognized obstetric bodies (American College of Obstetricians and Gynecologists (ACOG) and the Royal College of Obstetricians and Gynaecologists), relevant papers from the literature and the investigator's institutional PPH protocol. The final action items for the checklist were selected by consensus by all authors. A standardized, 23 key tasks were identified for inclusion on the PPH checklist (non-behavioral skills) and this checklist worked as the reference guide for pre and post-workshop evaluation of the trainees.
For the design of the non-technical skills evaluation scores, the authors reviewed the non-technical skills evaluation instruments, such as the Anaesthetists' Non-Technical Skills (ANTS) behavioural marker system and the Ottawa Global Rating Scale (GRS). The final action items for the checklist were selected by consensus by all authors. Standardized, evaluation and self-evaluation questionnaires were developed .
No educational training was performed before the performance of the first scenario and participants were naïve to the scenario before performing each simulation.
All the teams underwent standardized educational training immediately before the second, third, and fourth scenarios. Every standardized educational training consisted of a 30 minutes session. At the beginning of the session, each participant was invited to write, in three minutes, on a piece of paper, what they would do in case of postpartum bleeding. Afterward each participant was invited to share and to write on the blackboard, one by one, on turn, the clinical procedures that he had previously reported in his personal paper. After this session the instructor, after having asked to all the participant whether there were something else to add, integrated, if necessary, the missing elements by using the 23 key tasks and reconfirmed the agreement with the group itself in order to have a shared check-list of the postpartum hemorrhage treatment.
The scenario consisted of a severe PPH (1500 mL blood loss) due to refractory uterine atony in a multiparous 28-year-old patient who had undergone a spontaneous vaginal delivery. The patient became tachycardic and hypotensive consistent with hemorrhagic shock. All simulations were performed in the simulation room using a high-fidelity mannequin (SinMom Maternal and Neonatal Birthing Simulator, Laerdal, Norway). All simulations were videotaped. The simulation was stopped when each team completed all 23 tasks of the checklist, or when 15 min had elapsed.
A study investigator, expert in both PPH and simulation debriefing, not involved in the simulation, observed each scenario to record and check the team's technical skills according to the established 23 PPH key tasks. The behavioral scores were assigned by two independent observers, experts in communication and evaluation in simulation, who reviewed the videos of each simulation. After each simulation all participants were asked to complete a survey related to the leader and the team behaviors. Questions required a yes/no answer or an answer based on an ordinal scale (1=poor, 5=excellent). Survey questions are presented in the Appendix
- Conditions
- Obstetric Anesthesia Problems
- Being tested
- behavior of the leader
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavior of the leaderBehavioural
Also called non technical skills performed by the team
A study investigator, expert in both PPH and simulation debriefing, not involved in the simulation, observed each scenario to record and check the team's technical skills according to the established 23 PPH key tasks. The behavioral scores were assigned by two independent observers, experts in communication and evaluation in simulation, who reviewed the videos of each simulation each simulation all participants were asked to complete a survey related to the leader and the team behaviors. Questions required a yes/no answer or an answer based on an ordinal scale (1=poor, 5=excellent).
What is being measured
The primary outcome is the main question the study is designed to answer.
leader behavior
The behavioral scores (Likert Scale)) were assigned by two independent observers, experts in communication and evaluation in simulation, who reviewed the videos of each simulation.
Measured: 15 minutes
team performance
A study investigator, expert in both PPH and simulation debriefing, not involved in the simulation, observed each scenario to record and check the team's technical skills according to the established 23 PPH key task.
Measured: 15 minutes
leader self assessment
After each simulation all the leaders were asked to complete a survey related to the leader and the team behaviors. Questions required a yes/no answer or an answer based on an ordinal scale (1=poor, 5=excellent).
Measured: 15 minutes
team self assessment
After each simulation all participants were asked to complete a survey related to the leader and the team behaviors. Questions required a yes/no answer or an answer based on an ordinal scale (1=poor, 5=excellent).
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start10 Jan 2020
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Anesthesia ProblemsStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capogna Giorgio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Capogna Giorgio, European e-Learning School in Obstetric Anesthesia
- Investigators
- Giorgio Capogna, MD, Study director, European e-Learning School in Obstetric Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398602
- Sponsor's protocol ID
- EESOA8
- Status last verified
- May 2020
- First submitted
- 18 May 2020
- Last updated
- 26 May 2020
- Results posted
- No
- 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 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leader and Team Performance During PPH Simulated Scenario: a Comparison Between Self- and Expert's Assessment
- ClinicalTrials.gov ID
- NCT04398602
- Acronym / sponsor ID
- EESOA8
- Conditions
- Obstetric Anesthesia Problems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Capogna GiorgioUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 21 May 2020 (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.
The primary aim of this study is the progress of the performance of the leader and of the team for the postpartum hemorrhage (PPH) before and after four high-fidelity standardized scenarios of severe PPH (1500 mL blood loss) due to refractory uterine atony with anesthesia trainees.
Detailed description
8 teams were studied: each team consisted of six participants, all anesthesia trainees, who were given the following roles for the scenario: senior anesthesiologist, anesthesia trainee, obstetrician, midwife, and nurse. The teams encountered the same scenario of a patient with atonic PPH following vaginal delivery. The scenario was repeated four times and the assigned roles to the participants, except that one of the senior anesthesiologists, rotated every each scenario.For the design of the PPH checklist, the authors reviewed PPH guidelines from recognized obstetric bodies (American College of Obstetricians and Gynecologists (ACOG) and the Royal College of Obstetricians and Gynaecologists), relevant papers from the literature and the investigator's institutional PPH protocol. The final action items for the checklist were selected by consensus by all authors. A standardized, 23 key tasks were identified for inclusion on the PPH checklist (non-behavioral skills) and this checklist worked as the reference guide for pre and post-workshop evaluation of the trainees.
For the design of the non-technical skills evaluation scores, the authors reviewed the non-technical skills evaluation instruments, such as the Anaesthetists' Non-Technical Skills (ANTS) behavioural marker system and the Ottawa Global Rating Scale (GRS). The final action items for the checklist were selected by consensus by all authors. Standardized, evaluation and self-evaluation questionnaires were developed .
No educational training was performed before the performance of the first scenario and participants were naïve to the scenario before performing each simulation.
All the teams underwent standardized educational training immediately before the second, third, and fourth scenarios. Every standardized educational training consisted of a 30 minutes session. At the beginning of the session, each participant was invited to write, in three minutes, on a piece of paper, what they would do in case of postpartum bleeding. Afterward each participant was invited to share and to write on the blackboard, one by one, on turn, the clinical procedures that he had previously reported in his personal paper. After this session the instructor, after having asked to all the participant whether there were something else to add, integrated, if necessary, the missing elements by using the 23 key tasks and reconfirmed the agreement with the group itself in order to have a shared check-list of the postpartum hemorrhage treatment.
The scenario consisted of a severe PPH (1500 mL blood loss) due to refractory uterine atony in a multiparous 28-year-old patient who had undergone a spontaneous vaginal delivery. The patient became tachycardic and hypotensive consistent with hemorrhagic shock. All simulations were performed in the simulation room using a high-fidelity mannequin (SinMom Maternal and Neonatal Birthing Simulator, Laerdal, Norway). All simulations were videotaped. The simulation was stopped when each team completed all 23 tasks of the checklist, or when 15 min had elapsed.
A study investigator, expert in both PPH and simulation debriefing, not involved in the simulation, observed each scenario to record and check the team's technical skills according to the established 23 PPH key tasks. The behavioral scores were assigned by two independent observers, experts in communication and evaluation in simulation, who reviewed the videos of each simulation. After each simulation all participants were asked to complete a survey related to the leader and the team behaviors. Questions required a yes/no answer or an answer based on an ordinal scale (1=poor, 5=excellent). Survey questions are presented in the Appendix
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- anesthesia trainees
Key inclusion criteria (1 listed)
- anesthesia trainee
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavior of the leaderAlso: non technical skills performed by the teamA study investigator, expert in both PPH and simulation debriefing, not involved in the simulation, observed each scenario to record and check the team's technical skills according to the established 23 PPH key tasks. The behavioral scores were assigned by two independent observers, experts in communication and evaluation in simulation, who reviewed the videos of each simulation each simulation all participants were asked to complete a survey related to the leader and the team behaviors. Questions required a yes/no answer or an answer based on an ordinal scale (1=poor, 5=excellent). | Behavioural | – |
Primary outcome
leader behavior
Time frame: 15 minutes
The behavioral scores (Likert Scale)) were assigned by two independent observers, experts in communication and evaluation in simulation, who reviewed the videos of each simulation.
team performance
Time frame: 15 minutes
A study investigator, expert in both PPH and simulation debriefing, not involved in the simulation, observed each scenario to record and check the team's technical skills according to the established 23 PPH key task.
leader self assessment
Time frame: 15 minutes
After each simulation all the leaders were asked to complete a survey related to the leader and the team behaviors. Questions required a yes/no answer or an answer based on an ordinal scale (1=poor, 5=excellent).
team self assessment
Time frame: 15 minutes
After each simulation all participants were asked to complete a survey related to the leader and the team behaviors. Questions required a yes/no answer or an answer based on an ordinal scale (1=poor, 5=excellent).
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 26 May 2020.
- Individual participant dataSharing planned: No
Related trials for Obstetric Anesthesia Problems
Not yet recruiting
Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients
Obstetric, Cesarean Birth
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.
Giorgio Capogna, MD study director
European e-Learning School in Obstetric Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetric Anesthesia Problems, run by Capogna Giorgio at 1 site in Italy.
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 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
leader behavior (time frame: 15 minutes). The study lists 4 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 26 May 2020.