StressNCT02726724
Does the Presence of Observers Influence the Success of the Neonatal Endotracheal Intubation?
A study testing 5 observers and 1 observer in people with Stress, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
The Endotracheal intubation (ETI) of a neonate is a procedure that usually attracts a large number of observers. The fear of being judged by others could cause an increased level of stress, especially on the junior trainees. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- 5 observers and 1 observer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to Oct 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Junior residents during the first year of residency and respiratory therapy students who never had any experience with a real newborn intubation will participate to the studies. The mannequin used during the procedure is the same for all the students and is different from what they used during there training before starting the rotation in the NICU.
Who cannot join
- Students with a history of beta blockers within in the past year and students with a history of antidepressant medication are excluded.
Trial locations and contacts
1 site in 1 country.
About this study
The Endotracheal intubation (ETI) of a neonate is a procedure that usually attracts a large number of observers. The fear of being judged by others could cause an increased level of stress, especially on the junior trainees. Little research has focused on the effect of the audience on the level of stress and therefore, on the success rate of complicated procedures in neonatal intensive care.
Hypothesis:Investigators hypothesize that time to successful intubation (in seconds) will be longer with the presence of observers.
Read the detailed description
Objective: The aim of this study will be to provide objective evidence supporting that junior trainees are less successful at neonatal ETI when in the presence of a large audience. If this hypothesis is correct, this data will provide evidence to support the residents request for less people around during the procedure, which may increase the chance of a successful intubation.
After Investigators obtained written consent - the selected student-will be asked to wear a cardiac monitor and 5 minutes later after a period of rest, they will be called in the delivery room. Two minutes after their arrival they will be given a stylet and a 3.5 ET tube and will be asked to intubate orally a mannequin, after 30 seconds, the operator will be reminded of the time. After 45 seconds the attempts will be stopped.
Participants will be informed of their right to discontinue participation at any time. The trainee will be informed at the end of the experience about the aim of the study and will be asked to keep it confidential.
The trainees will be randomized in two groups that differentiate in the conditions under which they will start the intubation.
Condition A: Only the staff will be present with the operator Condition B: An audience of 5 people with at least 2 neonatologists will be present in case of junior resident or the responsible of stage in case of respiratory therapy students.
The residents who performed intubation in condition A will do a repeat intubation 24 hours later using condition B and vice versa. The time and the local of the 2 procedures will be the same in both conditions.
Time to successful intubation will be compared between the two experimental conditions for each subject with paired t test. A p<0.05 will be considered significant.
To estimate the required sample size, Investigators used the study O'Donnel and al who gave an approximate intubation time for trainees of 38 seconds with standard deviation of 20 seconds (14). Using an alpha threshold of 0.05 and power of 80 %, a sample size of 51 subjects is required to detect 8 second difference time between the two different groups. Eight seconds represents a 25 % change in time to intubate and is clinically significant for a newborn.
- Conditions
- Stress
- Being tested
- 5 observers, 1 observer
- Keywords
- Stress-Resident performance-Observers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 observersOther
1 observerOther
| Study group | Role | What they receive |
|---|---|---|
| Condition B | Experimental | An audience of 5 people with at least 2 neonatologists will be present with the operator during the intubation of the mannequin. Receives: Other: 5 observers |
| Condition A | Experimental | Only the staff will be present with the operator during the intubation of the mannequin. Receives: Other: 1 observer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the differences in the duration (seconds) to reach intubation of the mannequin between the two experimental conditions.
The duration of each individual attempt will be recorded as the time in seconds from insertion of the laryngoscope into the mouth to its removal.
Measured: 24 hour
Secondary outcomes (2)
Variability of the heart rate of the operator between the condition A and B.
After investigators obtained written consent - the selected student-will be asked to wear a cardiac monitor. The heart rate will be recorded before, during and after the end of the mannequin intubation. The variability in percentage during the intubation between the condition A and B will be compared.
Measured: 24 hour
The number of wrong ET length position between the condition A and B
Length of the position of the tube will be assessed 10 seconds after the intubation. Any position above 10 cm and bellow 8 cm will be considered wrong. The number of wrong ET length position between the condition A and B will be compared.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies 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
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Brahim Bensouda, Maisonneuve-Rosemont Hospital
- Investigators
- Brahim BB Bensouda, MD, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726724
- Sponsor's protocol ID
- Hopital Maisonneuve Rosemont
- Status last verified
- Dec 2017
- First submitted
- 22 Mar 2016
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Bensouda B, Mandel R, Mejri A, Lachapelle J, St-Hilaire M, Ali N. Effect of an audience on trainee stress and performance during simulated neonatal intubation: a randomized crossover trial. BMC Med Educ. 2018 Oct 3;18(1):230. doi: 10.1186/s12909-018-1338-4.
PubMed 30285715
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Presence of Observers Influence the Success of the Neonatal Endotracheal Intubation?
- ClinicalTrials.gov ID
- NCT02726724
- Acronym / sponsor ID
- Hopital Maisonneuve Rosemont
- Conditions
- Stress
- Keywords
- Stress-Resident performance-Observers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 4 Apr 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.
The Endotracheal intubation (ETI) of a neonate is a procedure that usually attracts a large number of observers. The fear of being judged by others could cause an increased level of stress, especially on the junior trainees. Little research has focused on the effect of the audience on the level of stress and therefore, on the success rate of complicated procedures in neonatal intensive care.
Hypothesis:Investigators hypothesize that time to successful intubation (in seconds) will be longer with the presence of observers.
Detailed description
Objective: The aim of this study will be to provide objective evidence supporting that junior trainees are less successful at neonatal ETI when in the presence of a large audience. If this hypothesis is correct, this data will provide evidence to support the residents request for less people around during the procedure, which may increase the chance of a successful intubation.
After Investigators obtained written consent - the selected student-will be asked to wear a cardiac monitor and 5 minutes later after a period of rest, they will be called in the delivery room. Two minutes after their arrival they will be given a stylet and a 3.5 ET tube and will be asked to intubate orally a mannequin, after 30 seconds, the operator will be reminded of the time. After 45 seconds the attempts will be stopped.
Participants will be informed of their right to discontinue participation at any time. The trainee will be informed at the end of the experience about the aim of the study and will be asked to keep it confidential.
The trainees will be randomized in two groups that differentiate in the conditions under which they will start the intubation.
Condition A: Only the staff will be present with the operator Condition B: An audience of 5 people with at least 2 neonatologists will be present in case of junior resident or the responsible of stage in case of respiratory therapy students.
The residents who performed intubation in condition A will do a repeat intubation 24 hours later using condition B and vice versa. The time and the local of the 2 procedures will be the same in both conditions.
Time to successful intubation will be compared between the two experimental conditions for each subject with paired t test. A p<0.05 will be considered significant.
To estimate the required sample size, Investigators used the study O'Donnel and al who gave an approximate intubation time for trainees of 38 seconds with standard deviation of 20 seconds (14). Using an alpha threshold of 0.05 and power of 80 %, a sample size of 51 subjects is required to detect 8 second difference time between the two different groups. Eight seconds represents a 25 % change in time to intubate and is clinically significant for a newborn.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Condition B | Experimental | Other: 5 observersAn audience of 5 people with at least 2 neonatologists will be present with the operator during the intubation of the mannequin. |
| Condition A | Experimental | Other: 1 observerOnly the staff will be present with the operator during the intubation of the mannequin. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Junior residents during the first year of residency and respiratory therapy students who never had any experience with a real newborn intubation will participate to the studies. The mannequin used during the procedure is the same for all the students and is different from what they used during there training before starting the rotation in the NICU.
Key exclusion criteria (1 listed)
- Students with a history of beta blockers within in the past year and students with a history of antidepressant medication are excluded.
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 |
|---|---|---|
| 5 observers | Other | Condition B |
| 1 observer | Other | Condition A |
Primary outcome
Evaluating the differences in the duration (seconds) to reach intubation of the mannequin between the two experimental conditions.
Time frame: 24 hour
The duration of each individual attempt will be recorded as the time in seconds from insertion of the laryngoscope into the mouth to its removal.
2 secondary outcomes
Variability of the heart rate of the operator between the condition A and B.
Time frame: 24 hour
The number of wrong ET length position between the condition A and B
Time frame: 24 hour
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 19 Dec 2017.
- Derived from this study: PubMed 30285715Bensouda B, Mandel R, Mejri A, Lachapelle J, St-Hilaire M, Ali N. Effect of an audience on trainee stress and performance during simulated neonatal intubation: a randomized crossover trial. BMC Med Educ. 2018 Oct 3;18(1):230. doi: 10.1186/s12909-018-1338-4.
- Individual participant dataSharing planned: Yes
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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.
Brahim BB Bensouda, MD principal investigator
Maisonneuve-Rosemont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5 observers and 1 observer in people with Stress, run by Maisonneuve-Rosemont Hospital at 1 site 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 19 Dec 2017. 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 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?
Evaluating the differences in the duration (seconds) to reach intubation of the mannequin between the two experimental conditions. (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02726724, which also lists 1 linked publication.
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 19 Dec 2017.