Phase 4
Completed N=45
Premedication for Non-Emergency Endotracheal Intubation In the NICU
Source: ClinicalTrials.gov NCT01749501 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Present the Percentage of Participants With an Excellent Ease of Intubation Rating — 91; 17 % reported as excellent
Summary
Those infants who received the muscle relaxation in combination with the vagolytic (reduce vagus nerve impulses) and pain medication will have reduced time to successful intubation (placement of tube into the lungs), a decrease in the number of attempts, and better intubation conditions reported by the practitioner. The objectives of the study include: 1.) Does the medication protocol outlined in this study provide optimal intubation conditions? (i.e.good jaw relaxation, open and immobile vocal cords and suppression of gag reflex) 2.) Does the addition of a muscle relaxant prior to intubation contribute to less attempts and achieving successful intubation as opposed to neonates who do not receive the muscle relaxant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Present the Percentage of Participants With an Excellent Ease of Intubation Rating |
91; 17 | — |
| SECONDARY Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded. |
2.94; 4.95 | — |
Eligibility Criteria
Inclusion criteria
- Infants admitted to the NICU at Beaumont Children's Hospital Royal Oak and Troy.
- Gestational Age 28 0/7 weeks (or post menstrual age 28 0/7 weeks) or higher
- Infants who require endotracheal intubation on a non-emergent basis
- Signed informed consent by parents
Exclusion criteria
- intubations that occurred in the delivery room or for other emergent basis,
- absence of intravenous access
- abnormality of the airway
- known or family history of neuromuscular disorder
- renal insufficiency (urine output 1.7 mg/dL if > 1 day of age)
- known hepatic insufficiency (abnormal liver function or coagulation laboratory results)
- Current diagnosis of pulmonary hypertension
- Any infant deemed by the attending neonatologist as unstable or unfit for the study
Data sourced from ClinicalTrials.gov (NCT01749501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.