Intubation ComplicationSMART PICUNCT06085326
Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
A study testing Smart Checklist in people with Intubation Complication, run by Children's Hospital of Philadelphia at 6 sites in United States.
Trial summary
The purpose of the study is to implement a patient-provider dyad tailored, Electronic Health Record (EHR)-informed, digitized Smart Checklist as a Quality Improvement (QI) intervention to support bedside clinician teams to reduce Adverse Airway Outcomes (AAO) across 6 diverse pediatric intensive care units (ICUs). Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Intubation Complication
- What is being tested?
- Smart Checklist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Oct 2023to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients intubated in the PICU at participating sites
Who cannot join
- Endotracheal tube exchanges, as this represents a distinct procedure
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Akron Children's Hospital
Akron, Ohio, 44308
Michelle Jacobs, MA CIP CCRP, 330-543-4969, mjacobs@akronchildrens.org
Christopher Page-Goertz, MD
- Recruiting
Emory University
Atlanta, Georgia, 30322
Robert E Nobles, DrPH, MPH, 404-727-3889, robert.e.nobles@emory.edu
Anna Lum, 404.785.5212, Anna.lum@choa.org
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Joanna Faulconer, 434-982-1855, Jld6p@virginia.edu
Michelle Adu-Darko, MD
- Recruiting
University of Arkansas
Little Rock, Arkansas, 72205
Jill Gassaway, 501-364-2862, gassawayja@archildrens.org
Ronald C Sanders Jr, MD
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Kristi DeHaai, MS, CIP, 402-559-9991, krdehaai@unmc.edu
Andrea Talukdar, MD
- Recruiting
Hasbro Children's Hospital
Providence, Rhode Island, 02903
Claire Walker, 401-444-8285
Lee A Polikoff, MD
About this study
The purpose of the study is to implement a patient-provider dyad tailored, Electronic Health Record (EHR)-informed, digitized Smart Checklist as a Quality Improvement (QI) intervention to support bedside clinician teams to reduce Adverse Airway Outcomes (AAO) across 6 diverse pediatric intensive care units (ICUs).
Read the detailed description
More than 20% of the critically ill children who require tracheal intubation suffer from adverse events. To reduce the adverse event risk, and optimize bedside team performance investigators will implement a digitized Smart Checklist that has three specific features: (1) prompts based on patient characteristics, (2) direct display of difficult airway status and airway information, and (3) high-risk warning based on predictive analytics.
This is a stepped-wedge cluster randomized trial of PICU patients who are intubated across 6 participating hospitals to determine if the Smart Checklist reduces the incidence of adverse tracheal intubation associated events.
The primary objective of this study is to determine the clinical impact of the personalized, dynamic, adaptive Smart Checklist implementation on the occurrence of Adverse Airway Outcomes (AAOs) in the pediatric ICU. The secondary objective is to characterize work systems and processes that affect clinical impact of the digitized Smart Checklist.
- Conditions
- Intubation Complication
- Being tested
- Smart Checklist
- Keywords
- Pediatric, Intubation, PICU, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart ChecklistOther
The digitized Smart Checklist includes three new features that currently do not exist on a paper checklist: 1) decision support prompts based on patient-provider dyad characteristics, 2) real time display of patient pertinent airway information from the EHR, and 3) high-risk warning alerts based on predictive analytics with potential explanatory factors from the model.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Intervention Phase | No intervention | PICU patients who are intubated without the Smart checklist |
| Post-Intervention Phase | Active comparator | PICU patients who are intubated after implementation of the Smart checklist in the pediatric intensive care unit. Receives: Other: Smart Checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Airway Outcomes
A composite outcome for adverse events or acute oxygen desaturation <80%
Measured: During the intubation procedure and up to 20 minutes after procedure
Secondary outcomes (3)
Duration of invasive mechanical ventilation
Duration of invasive mechanical ventilation (time to extubation or tracheostomy)
Measured: During the ICU stay, up to 180 days
Duration of ICU stay
Duration of ICU stay (days)
Measured: During the ICU stay, up to 180 days
ICU mortality
ICU mortality (all cause)
Measured: During the ICU stay, up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start1 Oct 2023
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Akira Nishisaki, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085326
- Sponsor's protocol ID
- 23-021168
- Other IDs
- R01HS029188
- Acronym
- SMART PICU
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PI will share unique research resources developed through this Agency for Healthcare Research and Quality (AHRQ)-funded grant to enhance the value and further the advancement of research. The PI will make data available after study completion and in accordance with AHRQ policies. The data will only be provided to those investigators who agree to adhere to a signed research data use agreement. The execution of the agreement will require approval by the Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB) or demonstration of IRB exemption per institutional policy. The data and associated documentation will be available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and does not identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
- ClinicalTrials.gov ID
- NCT06085326
- Acronym / sponsor ID
- SMART PICU / 23-021168
- Conditions
- Intubation Complication
- Keywords
- Pediatric, Intubation, PICU, Safety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 16 Oct 2023 (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 purpose of the study is to implement a patient-provider dyad tailored, Electronic Health Record (EHR)-informed, digitized Smart Checklist as a Quality Improvement (QI) intervention to support bedside clinician teams to reduce Adverse Airway Outcomes (AAO) across 6 diverse pediatric intensive care units (ICUs).
Detailed description
More than 20% of the critically ill children who require tracheal intubation suffer from adverse events. To reduce the adverse event risk, and optimize bedside team performance investigators will implement a digitized Smart Checklist that has three specific features: (1) prompts based on patient characteristics, (2) direct display of difficult airway status and airway information, and (3) high-risk warning based on predictive analytics.
This is a stepped-wedge cluster randomized trial of PICU patients who are intubated across 6 participating hospitals to determine if the Smart Checklist reduces the incidence of adverse tracheal intubation associated events.
The primary objective of this study is to determine the clinical impact of the personalized, dynamic, adaptive Smart Checklist implementation on the occurrence of Adverse Airway Outcomes (AAOs) in the pediatric ICU. The secondary objective is to characterize work systems and processes that affect clinical impact of the digitized Smart Checklist.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Intervention Phase | No intervention | –PICU patients who are intubated without the Smart checklist |
| Post-Intervention Phase | Active comparator | Other: Smart ChecklistPICU patients who are intubated after implementation of the Smart checklist in the pediatric intensive care unit. |
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All patients intubated in the PICU at participating sites
Key exclusion criteria (1 listed)
- Endotracheal tube exchanges, as this represents a distinct procedure
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 |
|---|---|---|
| Smart ChecklistThe digitized Smart Checklist includes three new features that currently do not exist on a paper checklist: 1) decision support prompts based on patient-provider dyad characteristics, 2) real time display of patient pertinent airway information from the EHR, and 3) high-risk warning alerts based on predictive analytics with potential explanatory factors from the model. | Other | Post-Intervention Phase |
Primary outcome
Adverse Airway Outcomes
Time frame: During the intubation procedure and up to 20 minutes after procedure
A composite outcome for adverse events or acute oxygen desaturation <80%
3 secondary outcomes
Duration of invasive mechanical ventilation
Time frame: During the ICU stay, up to 180 days
Duration of ICU stay
Time frame: During the ICU stay, up to 180 days
ICU mortality
Time frame: During the ICU stay, up to 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Yes. The PI will share unique research resources developed through this Agency for Healthcare Research and Quality (AHRQ)-funded grant to enhance the value and further the advancement of research. The PI will make data available after study completion and in accordance with AHRQ policies. The data will only be provided to those investigators who agree to adhere to a signed research data use agreement. The execution of the agreement will require approval by the Children's Hospital of Philadelphia (CHOP) Institutional Review Board (IRB) or demonstration of IRB exemption per institutional policy. The data and associated documentation will be available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and does not identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed
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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.
Akira Nishisaki, MD, MSCE principal investigator
Children's Hospital of Philadelphia
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Checklist in people with Intubation Complication, run by Children's Hospital of Philadelphia at 6 sites 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akira Nishisaki, MD, MSCE (215-590-1000, nishisaki@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Airway Outcomes (time frame: During the intubation procedure and up to 20 minutes after procedure). 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 22 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.