Neonatal Intubation PerformanceNCT02758704
Impact of Stress on Performance of Neonatal Endotracheal Intubation
A study testing High stress, Low stress and Endotracheal intubation on mannequin in people with Neonatal Intubation Performance, run by St. Justine's Hospital at 2 sites in Canada.
Trial summary
This study will be a randomized controlled trial designed to analyse the impact of stress on the success rate of a simulated neonatal endotracheal intubation. To do this, pediatric residents will be enrolled and randomized to either a high-stress (HS) or low-stress (LS) environment where they will be asked to perform… Read more about this study
- Who is it for?
- Ages Up to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Neonatal Intubation Performance
- What is being tested?
- High stress, Low stress and Endotracheal intubation on mannequin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2015to 30 Jun 2021
- Phase
- Interventional
- 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 Up to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All residents enrolled in the pediatric residency program and subspecialties of University of Montreal.
Who cannot join
- Residents who have a medical condition that can impact cortisol levels, such as pregnancy, will be excluded from the cortisol analysis.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Sainte-Justine Hospital
Montreal, Quebec, H3T 1C4
About this study
Official title: Impact of Stress on the Performance of Neonatal Endotracheal Intubation: A Randomized Controlled Trial on Manikins
This study will be a randomized controlled trial designed to analyse the impact of stress on the success rate of a simulated neonatal endotracheal intubation. To do this, pediatric residents will be enrolled and randomized to either a high-stress (HS) or low-stress (LS) environment where they will be asked to perform a standard neonatal intubation procedure. Subjects will then cross-over to the second scenario within a short window (1-2 weeks). Outcome measures include: endotracheal intubation success rate and assessment of the procedure performance by video-review using a standardized checklist rated by two independent reviewers. Stress level will be measured using salivary cortisol, heart rate and a standardized anxiety questionnaire.
Read the detailed description
Although a required skill in pediatric residency programs, success rate of neonatal endotracheal intubation (ETI) among trainees is known to be inadequate. Currently, it is taught using simulation; a teaching method that seems useful mainly for limited short-term retention of skill. In the clinical setting, ETI is often associated with stress, which could explain the limited educational impact of simulation training. The effect of stress on the success of this procedure is poorly studied.
Therefore, the objective of the investigators study is to assess the impact of stress on the success of simulated neonatal ETI.
Hypotheses to be tested: The primary hypothesis is that stressful conditions will negatively impact residents' success of endotracheal intubation on neonatal manikins. Secondary hypotheses include: 1) stressful conditions will be associated with an increased time to successful intubation and decreased performance on the intubation checklist; 2) there will be a positive correlation between heart rate/cortisol levels and resident's response on the State Trait Anxiety Inventory questionnaire (STAI).
Design: This study will be a crossover randomized controlled trial in the setting of the simulation laboratory. Subjects will include pediatric residents and pediatric subspecialty residents. Exclusion criteria will include any medical condition or medication that can have a significant impact on cortisol levels. The residents will be randomized using sealed envelopes to perform a neonatal ETI in a low or a high stress environment, and then crossover to the other on a separate day. Stress will be created and standardized by using audio alarms, third party supervisors and simulated manikin instability. Level of stress of participants will be assessed at baseline during a lecture, upon arrival to the simulation center and after the simulated procedure. This will be done using salivary cortisol, heart rate and the STAI questionnaire. ETI procedures will be videotaped and performance will be assessed by two external reviewers using a validated checklist.
Analysis: Primary and secondary outcomes include: success rate, checklist performance, time to successful intubation, rate of esophageal intubation and stress levels (cortisol, heart rate and questionnaire). Continuous variables will be analyzed by the independent sample t test and categorical variables will be analyzed by Fisher's exact test. Statistical significance will be defined by a 2-sided alpha of 0.05 and power of 80%. To demonstrate a decrease of success rate of ETI from 80% (retrieved from previous simulation study in a LS environment) to 60%, 64 intubations are needed per group.
Anticipated outcomes \& potential problems: Demonstrating a decrease in success rate of ETI in the HS environment will aid to improve simulation-based training of neonatal ETI. In the future, the HS environment model can be used as an intermediate training process to prepare residents to the stress related to this procedure in the clinical world.
- Conditions
- Neonatal Intubation Performance
- Being tested
- High stress, Low stress, Endotracheal intubation on mannequin
- Keywords
- Intubation, Neonatal, Teaching, Stress, Simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High stressOther
Generation of a stressful environment during a neonatal intubation procedure.
Low stressOther
Absence of stressful stimuli during neonatal intubation procedure
Endotracheal intubation on mannequinOther
Endotracheal intubation will take place at the simulation centre on a mannequin.
| Study group | Role | What they receive |
|---|---|---|
| High-Stress (HS) | Experimental | In the HS environment, the resident will be exposed to various stressors. There will be the presence of audio alarms as well as the presence of a senior physician who will be supervising the performance of the resident. In addition, the mannequin will be slightly unstable which will be reflected in its oxygen saturation dropping throughout the first 30 seconds the procedure. Receives: Other: High stress; Other: Endotracheal intubation on mannequin |
| Low-Stress (LS) | Active comparator | In the LS environment, there will be absence of audio (alarms), physical (third-party supervisor, nurse and respiratory therapist) and situational (unstable infant) stressors. Receives: Other: Low stress; Other: Endotracheal intubation on mannequin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of endotracheal intubation procedure
Successful intubation will be defined as correct placement of the endotracheal tube just below the level of the vocal cords and will be verified by one of the investigators at the end of the procedure. Each attempt will be limited to 30 sec, as per Neonatal Resuscitation Program guidelines. An esophageal intubation will be defined as the absence of chest rise upon completion of the procedure.
Measured: 5 minutes
Intubation skill performance
Endotracheal intubation procedures will be videotaped and performance will be assessed by two external reviewers using an ETI checklist (in the process of validation).
Measured: within 24 months
Secondary outcomes (5)
Rate of esophageal intubation
Measured: 5 minutes
Stress level - Cortisol Measurement
At rest, before and after each scenario
Measured: within 24 months
Stress level - Heart Rate
At rest, before and after each scenario
Measured: within 24 months
Stress level - STAI Questionnaire
Subjects will be asked to fill out the State-Trait Anxiety Inventory questionnaire at rest, prior to and after each simulation scenario
Measured: within 24 months
Duration of intubation
Timing will begin when the laryngoscope's blade is inserted into the manikin's mouth. The end of the attempt is indicated by the laryngoscope blade leaving the mannikin's mouth.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startOct 2015
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Intubation PerformanceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Children's Hospital
- Responsible party
- Principal investigator, Ahmed Moussa, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758704
- Sponsor's protocol ID
- 4143
- Status last verified
- Oct 2021
- First submitted
- 27 Apr 2016
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Stress on the Performance of Neonatal Endotracheal Intubation: A Randomized Controlled Trial on Manikins
- ClinicalTrials.gov ID
- NCT02758704
- Acronym / sponsor ID
- 4143
- Conditions
- Neonatal Intubation Performance
- Keywords
- Intubation, Neonatal, Teaching, Stress, Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Alberta Children's Hospital
- Study start
- Oct 2015 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 2 May 2016 (estimated)
- 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.
This study will be a randomized controlled trial designed to analyse the impact of stress on the success rate of a simulated neonatal endotracheal intubation. To do this, pediatric residents will be enrolled and randomized to either a high-stress (HS) or low-stress (LS) environment where they will be asked to perform a standard neonatal intubation procedure. Subjects will then cross-over to the second scenario within a short window (1-2 weeks). Outcome measures include: endotracheal intubation success rate and assessment of the procedure performance by video-review using a standardized checklist rated by two independent reviewers. Stress level will be measured using salivary cortisol, heart rate and a standardized anxiety questionnaire.
Detailed description
Although a required skill in pediatric residency programs, success rate of neonatal endotracheal intubation (ETI) among trainees is known to be inadequate. Currently, it is taught using simulation; a teaching method that seems useful mainly for limited short-term retention of skill. In the clinical setting, ETI is often associated with stress, which could explain the limited educational impact of simulation training. The effect of stress on the success of this procedure is poorly studied.
Therefore, the objective of the investigators study is to assess the impact of stress on the success of simulated neonatal ETI.
Hypotheses to be tested: The primary hypothesis is that stressful conditions will negatively impact residents' success of endotracheal intubation on neonatal manikins. Secondary hypotheses include: 1) stressful conditions will be associated with an increased time to successful intubation and decreased performance on the intubation checklist; 2) there will be a positive correlation between heart rate/cortisol levels and resident's response on the State Trait Anxiety Inventory questionnaire (STAI).
Design: This study will be a crossover randomized controlled trial in the setting of the simulation laboratory. Subjects will include pediatric residents and pediatric subspecialty residents. Exclusion criteria will include any medical condition or medication that can have a significant impact on cortisol levels. The residents will be randomized using sealed envelopes to perform a neonatal ETI in a low or a high stress environment, and then crossover to the other on a separate day. Stress will be created and standardized by using audio alarms, third party supervisors and simulated manikin instability. Level of stress of participants will be assessed at baseline during a lecture, upon arrival to the simulation center and after the simulated procedure. This will be done using salivary cortisol, heart rate and the STAI questionnaire. ETI procedures will be videotaped and performance will be assessed by two external reviewers using a validated checklist.
Analysis: Primary and secondary outcomes include: success rate, checklist performance, time to successful intubation, rate of esophageal intubation and stress levels (cortisol, heart rate and questionnaire). Continuous variables will be analyzed by the independent sample t test and categorical variables will be analyzed by Fisher's exact test. Statistical significance will be defined by a 2-sided alpha of 0.05 and power of 80%. To demonstrate a decrease of success rate of ETI from 80% (retrieved from previous simulation study in a LS environment) to 60%, 64 intubations are needed per group.
Anticipated outcomes \& potential problems: Demonstrating a decrease in success rate of ETI in the HS environment will aid to improve simulation-based training of neonatal ETI. In the future, the HS environment model can be used as an intermediate training process to prepare residents to the stress related to this procedure in the clinical world.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Stress (HS) | Experimental | Other: High stress, Other: Endotracheal intubation on mannequinIn the HS environment, the resident will be exposed to various stressors. There will be the presence of audio alarms as well as the presence of a senior physician who will be supervising the performance of the resident. In addition, the mannequin will be slightly unstable which will be reflected in its oxygen saturation dropping throughout the first 30 seconds the procedure. |
| Low-Stress (LS) | Active comparator | Other: Low stress, Other: Endotracheal intubation on mannequinIn the LS environment, there will be absence of audio (alarms), physical (third-party supervisor, nurse and respiratory therapist) and situational (unstable infant) stressors. |
Who may qualify
- Ages
- Up to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All residents enrolled in the pediatric residency program and subspecialties of University of Montreal.
Key exclusion criteria (1 listed)
- Residents who have a medical condition that can impact cortisol levels, such as pregnancy, will be excluded from the cortisol analysis.
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 |
|---|---|---|
| High stressGeneration of a stressful environment during a neonatal intubation procedure. | Other | High-Stress (HS) |
| Low stressAbsence of stressful stimuli during neonatal intubation procedure | Other | Low-Stress (LS) |
| Endotracheal intubation on mannequinEndotracheal intubation will take place at the simulation centre on a mannequin. | Other | High-Stress (HS), Low-Stress (LS) |
Primary outcome
Success rate of endotracheal intubation procedure
Time frame: 5 minutes
Successful intubation will be defined as correct placement of the endotracheal tube just below the level of the vocal cords and will be verified by one of the investigators at the end of the procedure. Each attempt will be limited to 30 sec, as per Neonatal Resuscitation Program guidelines. An esophageal intubation will be defined as the absence of chest rise upon completion of the procedure.
Intubation skill performance
Time frame: within 24 months
Endotracheal intubation procedures will be videotaped and performance will be assessed by two external reviewers using an ETI checklist (in the process of validation).
5 secondary outcomes
Rate of esophageal intubation
Time frame: 5 minutes
Stress level - Cortisol Measurement
Time frame: within 24 months
Stress level - Heart Rate
Time frame: within 24 months
Stress level - STAI Questionnaire
Time frame: within 24 months
Duration of intubation
Time frame: 5 minutes
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 7 Oct 2021.
- Individual participant dataSharing planned: Yes
Related trials for Neonatal Intubation Performance
Not yet recruiting
An Educational Intervention to Improve the Success of Intubation in Newborns Using a Video Laryngoscope by Reducing the Time the Procedure Takes.
Respiratory Distress Syndrome, Newborn, Endotracheal Intubation
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High stress, Low stress and Endotracheal intubation on mannequin in people with Neonatal Intubation Performance, run by St. Justine's Hospital at 2 sites in Canada.
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 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Success rate of endotracheal intubation procedure (time frame: 5 minutes). The study lists 2 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 7 Oct 2021.