Ventilatory FailureNCT05147922
Neo RQI: The Effect of Neonatal Resuscitation Quality Improvement Cart Booster Training Skills Retention
A study testing Booster Training with the Neonatal Resuscitation Quality Improvement Cart in people with Ventilatory Failure, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a prospective multicenter randomized control trial to assess percentage mask leak six months post instructor led positive pressure ventilation skills training in providers who undergo booster training compared to those who do not undergo any booster training Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ventilatory Failure
- What is being tested?
- Booster Training with the Neonatal Resuscitation Quality Improvement Cart
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 31 Dec 2023
- 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
- Any Neonatal Resuscitation Program-card carrying provider at the participating sites (University of Texas Southwestern, Stanford University and St. Louis University).
Who cannot join
- Novice providers, who have never taken an Neonatal Resuscitation Program course, will be excluded as participant may not be familiar with the equipment to initiate positive pressure ventilation skills without a face-to-face interaction with an instructor
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas, Southwestern
Dallas, Texas, 75204-2317
About this study
Official title: Neo RQI: Evaluating the Effect of Neonatal Resuscitation Quality Improvement Cart Booster Training on Provider Positive Pressure Ventilation Skills Retention
This is a prospective multicenter randomized control trial to assess percentage mask leak six months post instructor led positive pressure ventilation skills training in providers who undergo booster training compared to those who do not undergo any booster training
Read the detailed description
Baseline positive pressure ventilation skill assessment of all study participants: Site principal investigators will recruit eligible providers for the trial. Participants will fill out study enrollment sheet which will ask for 1. Demographic information 2. Profession 3. Experience (number of times positive pressure ventilation performed on a newborn in the last 6 months) 4. Last time Neonatal Resuscitation Program course attended and 5. Institution. Participants will perform 1 minute of positive pressure ventilation on the cart. During this baseline assessment, there is no audio-visual feedback or display. The cart will record data on mask leak, pressure used, ventilation rate, head positioning.
Pre-randomization Standardized Instructor Led Skills Training: All study participants will undergo the standard instructor-led positive pressure ventilation skills training. Each site will have a designated study instructor who will remain blinded to the baseline positive pressure ventilation skill assessment data. Study instructors will use a standardized script as a guide for the instructor led positive pressure ventilation skills training. This training will occur with the same manikin and equipment as the one available at the cart. This training will decrease the impact of variability in prior training received by the study participants.
Post- Instructor led positive pressure ventilation skills training Assessment: Immediately after the instructor led training, participants will perform 1-minute positive pressure ventilation on the cart. This will also be a blinded assessment without any display or feedback. Comparison of pre- and post- instructor led training assessments will provide unique data to evaluate if instructor led training changes the positive pressure ventilation skills.
Randomization with minimization procedure: Randomization will be provided by a secure website using the computer-generated randomization and the minimization procedure. The goal of the minimization procedure is to prevent an imbalance of factors that may influence positive pressure ventilation skill retention. Factors that will be taken into account during minimization procedure are
- PPV skill proficiency during baseline pre-instructor led training assessment: Based on the pre-training skill assessment, each participant will be coded as a Group A [Proficient] or Group B [not proficient]. Participants will be considered proficient if participants are able to achieve low mask leak (< 30%) on >80% of ventilations provided. Only study Principal investigator and research nurse will have access to this data. 2. Profession 3. Experience (number of times positive pressure ventilation performed on a newborn in the last 6 months) 4. Last time NRP course attended and 5. Institution. Based on this information, the randomization website will assign them to the intervention (booster training) or control group (no booster training) with 1:1 allocation.
- Conditions
- Ventilatory Failure
- Being tested
- Booster Training with the Neonatal Resuscitation Quality Improvement Cart
- Medical subject headings
- Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Booster Training with the Neonatal Resuscitation Quality Improvement CartBehavioural
The cart will give providers audio-visual feedback and walk them through how to perform effective positive pressure ventilation with correct head positioning, appropriate Peak Inspiratory Pressure and Peak End Expiratory Pressure, no mask leak and ventilation rate of 40 per minute. Participants will be able to spend up to 30 minutes with the cart before undergoing their 1 minute assessment, which will be without feedback.
| Study group | Role | What they receive |
|---|---|---|
| Booster Training Group | Experimental | Participants randomized to intervention will undergo booster training sessions with the RQI cart (including audiovisual feedback) at 3, 6 and 9 months post instructor-led training session. Following each of these booster sessions, the participants will undergo 1 minute assessments, without feedback. Receives: Behavioral: Booster Training with the Neonatal Resuscitation Quality Improvement Cart |
| No Booster Training Group | No intervention | Participants randomized to the control group will undergo 1 minute assessments, without feedback, at 6 and 9 months. Participants will not be able to access the RQI cart outside of their assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mask Leak
The primary outcome of the study is the proportion of subjects who provide >80% ventilation with low mask leak (< 30% mask leak) during the one-minute assessment at six months from the instructor led positive pressure ventilation skills training
Measured: 6 months after initial enrollment and instructor-led training session
Secondary outcomes (5)
Tidal volumes
Measured percentage of breaths provided in goal range for tidal volume
Measured: 6 month and 9 month assessments
Positive Pressure Ventilation composite score
Calculated score, based on peak inspiratory pressure score, positive end expiratory pressure score, rate score, and mask leak score, per provider at each assessment
Measured: 6 month and 9 month assessments
Peak Inspiratory Pressure score
Measured percentage of breaths provided in goal range for peak inspiratory pressure
Measured: 6 month and 9 month assessments
Positive End Expiratory Pressure score
Measured percentage of breaths provided in goal range for positive end expiratory pressure
Measured: 6 month and 9 month assessments
Rate score
Measured percentage of breaths provided in goal range for rate
Measured: 6 month and 9 month assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start18 Apr 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ventilatory FailureStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Pediatrics
- Responsible party
- Principal investigator, Vishal Kapadia, University of Texas Southwestern Medical Center
- Investigators
- Priya Sharma, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147922
- Sponsor's protocol ID
- STU2021-0282
- Status last verified
- Mar 2024
- First submitted
- 23 Nov 2021
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wyckoff MH, Wyllie J, Aziz K, de Almeida MF, Fabres J, Fawke J, Guinsburg R, Hosono S, Isayama T, Kapadia VS, Kim HS, Liley HG, McKinlay CJD, Mildenhall L, Perlman JM, Rabi Y, Roehr CC, Schmolzer GM, Szyld E, Trevisanuto D, Velaphi S, Weiner GM; Neonatal Life Support Collaborators. Neonatal Life Support: 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2020 Oct 20;142(16_suppl_1):S185-S221. doi: 10.1161/CIR.0000000000000895. Epub 2020 Oct 21.
PubMed 33084392Schmolzer GM, Dawson JA, Kamlin CO, O'Donnell CP, Morley CJ, Davis PG. Airway obstruction and gas leak during mask ventilation of preterm infants in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2011 Jul;96(4):F254-7. doi: 10.1136/adc.2010.191171. Epub 2010 Nov 16.
PubMed 21081593Schmolzer GM, Kamlin OC, O'Donnell CP, Dawson JA, Morley CJ, Davis PG. Assessment of tidal volume and gas leak during mask ventilation of preterm infants in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2010 Nov;95(6):F393-7. doi: 10.1136/adc.2009.174003. Epub 2010 Jun 14.
PubMed 20547584Martin P, Theobald P, Kemp A, Maguire S, Maconochie I, Jones M. Real-time feedback can improve infant manikin cardiopulmonary resuscitation by up to 79%--a randomised controlled trial. Resuscitation. 2013 Aug;84(8):1125-30. doi: 10.1016/j.resuscitation.2013.03.029. Epub 2013 Apr 6.
PubMed 23571117
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neo RQI: Evaluating the Effect of Neonatal Resuscitation Quality Improvement Cart Booster Training on Provider Positive Pressure Ventilation Skills Retention
- ClinicalTrials.gov ID
- NCT05147922
- Acronym / sponsor ID
- STU2021-0282
- Conditions
- Ventilatory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- American Academy of Pediatrics
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 7 Dec 2021 (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.
This is a prospective multicenter randomized control trial to assess percentage mask leak six months post instructor led positive pressure ventilation skills training in providers who undergo booster training compared to those who do not undergo any booster training
Detailed description
Baseline positive pressure ventilation skill assessment of all study participants: Site principal investigators will recruit eligible providers for the trial. Participants will fill out study enrollment sheet which will ask for 1. Demographic information 2. Profession 3. Experience (number of times positive pressure ventilation performed on a newborn in the last 6 months) 4. Last time Neonatal Resuscitation Program course attended and 5. Institution. Participants will perform 1 minute of positive pressure ventilation on the cart. During this baseline assessment, there is no audio-visual feedback or display. The cart will record data on mask leak, pressure used, ventilation rate, head positioning.
Pre-randomization Standardized Instructor Led Skills Training: All study participants will undergo the standard instructor-led positive pressure ventilation skills training. Each site will have a designated study instructor who will remain blinded to the baseline positive pressure ventilation skill assessment data. Study instructors will use a standardized script as a guide for the instructor led positive pressure ventilation skills training. This training will occur with the same manikin and equipment as the one available at the cart. This training will decrease the impact of variability in prior training received by the study participants.
Post- Instructor led positive pressure ventilation skills training Assessment: Immediately after the instructor led training, participants will perform 1-minute positive pressure ventilation on the cart. This will also be a blinded assessment without any display or feedback. Comparison of pre- and post- instructor led training assessments will provide unique data to evaluate if instructor led training changes the positive pressure ventilation skills.
Randomization with minimization procedure: Randomization will be provided by a secure website using the computer-generated randomization and the minimization procedure. The goal of the minimization procedure is to prevent an imbalance of factors that may influence positive pressure ventilation skill retention. Factors that will be taken into account during minimization procedure are
- PPV skill proficiency during baseline pre-instructor led training assessment: Based on the pre-training skill assessment, each participant will be coded as a Group A [Proficient] or Group B [not proficient]. Participants will be considered proficient if participants are able to achieve low mask leak (< 30%) on >80% of ventilations provided. Only study Principal investigator and research nurse will have access to this data. 2. Profession 3. Experience (number of times positive pressure ventilation performed on a newborn in the last 6 months) 4. Last time NRP course attended and 5. Institution. Based on this information, the randomization website will assign them to the intervention (booster training) or control group (no booster training) with 1:1 allocation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Booster Training Group | Experimental | Behavioral: Booster Training with the Neonatal Resuscitation Quality Improvement CartParticipants randomized to intervention will undergo booster training sessions with the RQI cart (including audiovisual feedback) at 3, 6 and 9 months post instructor-led training session. Following each of these booster sessions, the participants will undergo 1 minute assessments, without feedback. |
| No Booster Training Group | No intervention | –Participants randomized to the control group will undergo 1 minute assessments, without feedback, at 6 and 9 months. Participants will not be able to access the RQI cart outside of their assessment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any Neonatal Resuscitation Program-card carrying provider at the participating sites (University of Texas Southwestern, Stanford University and St. Louis University).
Key exclusion criteria (1 listed)
- Novice providers, who have never taken an Neonatal Resuscitation Program course, will be excluded as participant may not be familiar with the equipment to initiate positive pressure ventilation skills without a face-to-face interaction with an instructor
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 |
|---|---|---|
| Booster Training with the Neonatal Resuscitation Quality Improvement CartThe cart will give providers audio-visual feedback and walk them through how to perform effective positive pressure ventilation with correct head positioning, appropriate Peak Inspiratory Pressure and Peak End Expiratory Pressure, no mask leak and ventilation rate of 40 per minute. Participants will be able to spend up to 30 minutes with the cart before undergoing their 1 minute assessment, which will be without feedback. | Behavioural | Booster Training Group |
Primary outcome
Mask Leak
Time frame: 6 months after initial enrollment and instructor-led training session
The primary outcome of the study is the proportion of subjects who provide >80% ventilation with low mask leak (< 30% mask leak) during the one-minute assessment at six months from the instructor led positive pressure ventilation skills training
5 secondary outcomes
Tidal volumes
Time frame: 6 month and 9 month assessments
Positive Pressure Ventilation composite score
Time frame: 6 month and 9 month assessments
Peak Inspiratory Pressure score
Time frame: 6 month and 9 month assessments
Positive End Expiratory Pressure score
Time frame: 6 month and 9 month assessments
Rate score
Time frame: 6 month and 9 month assessments
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 20 Mar 2024.
- Background: PubMed 33084392Wyckoff MH, Wyllie J, Aziz K, de Almeida MF, Fabres J, Fawke J, Guinsburg R, Hosono S, Isayama T, Kapadia VS, Kim HS, Liley HG, McKinlay CJD, Mildenhall L, Perlman JM, Rabi Y, Roehr CC, Schmolzer GM, Szyld E, Trevisanuto D, Velaphi S, Weiner GM; Neonatal Life Support Collaborators. Neonatal Life Support: 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2020 Oct 20;142(16_suppl_1):S185-S221. doi: 10.1161/CIR.0000000000000895. Epub 2020 Oct 21.
- Background: PubMed 21081593Schmolzer GM, Dawson JA, Kamlin CO, O'Donnell CP, Morley CJ, Davis PG. Airway obstruction and gas leak during mask ventilation of preterm infants in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2011 Jul;96(4):F254-7. doi: 10.1136/adc.2010.191171. Epub 2010 Nov 16.
- Background: PubMed 20547584Schmolzer GM, Kamlin OC, O'Donnell CP, Dawson JA, Morley CJ, Davis PG. Assessment of tidal volume and gas leak during mask ventilation of preterm infants in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2010 Nov;95(6):F393-7. doi: 10.1136/adc.2009.174003. Epub 2010 Jun 14.
- Background: PubMed 23571117Martin P, Theobald P, Kemp A, Maguire S, Maconochie I, Jones M. Real-time feedback can improve infant manikin cardiopulmonary resuscitation by up to 79%--a randomised controlled trial. Resuscitation. 2013 Aug;84(8):1125-30. doi: 10.1016/j.resuscitation.2013.03.029. Epub 2013 Apr 6.
- 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.
Priya Sharma, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Booster Training with the Neonatal Resuscitation Quality Improvement Cart in people with Ventilatory Failure, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 20 Mar 2024. 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 United States. 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?
Mask Leak (time frame: 6 months after initial enrollment and instructor-led training session). 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 NCT05147922, which also lists 4 linked publications.
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 20 Mar 2024.