Optimizing Tracheal Intubation Outcomes and Neonatal Safety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 1
SponsorChildren's Hospital of Philadelphia
About this trial
The purpose of the study is to assess the impact of a personalized intubation planning tool, the Personalized INtubation Safety (PINS) Bundle on intubation procedural safety and clinical outcomes among patients intubated in the neonatal intensive care unit (NICU) setting.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Personalized Intubation Safety (PINS) Bundle
Other interventionThe Personalized Intubation Safety (PINS) Bundle addresses 5 core domains that are individualized to the patient to develop a prospective, personalized and comprehensive multidisciplinary intubation plan: (1) patient risk assessment; (2) treatment threshold for intubation; (3) premedication (promoting paralytic premedication); (4) equipment (promoting video laryngoscope); (5) provider selection and escalation plan
Treatment groups
3,000 Participants
are divided into 2 treatment groupsGroup A: Pre-Intervention PhaseNo intervention 0 interventions
Group B: Post-intervention PhaseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Tracheal intubation associated event (TIAE)
Any adverse tracheal intubation associated event (TIAE) during the intubation encounter. In NEAR4NEOS database, a comprehensive group of adverse TIAEs are based on standard consensus-based definitions and classified as severe and non-severe
Time frame
During the intubation procedure, on average 20 minutesSecondary outcomes
1
Severe TIAE
Any severe TIAE, defined by National Emergency Airway Registry for Neonates (NEAR4NEOS) Operational Definitions
Time frame
During the intubation procedure, on average 20 minutes2
Magnitude of oxygen desaturation
Difference between highest oxygen saturation (SpO2) value immediately before first intubation attempt and lowest value at any point during the procedure
Time frame
During the intubation procedure, on average 20 minutes3
Number of subjects with multiple intubation attempts (>2 attempts)
More than 2 intubation attempts
Time frame
During the intubation procedure, on average 20 minutes4
Duration of mechanical ventilation
Duration of mechanical ventilation after the immediate intubation encounter
Time frame
Through study completion, on average 90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Philadelphia
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov