Respiratory Distress Syndrome Clinical Trial
Official title:
Premedication for Non-Emergency Endotracheal Intubation In the NICU
Verified date | October 2017 |
Source | William Beaumont Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | January 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion criteria: 1. Infants admitted to the NICU at Beaumont Children's Hospital Royal Oak and Troy. 2. Gestational Age 28 0/7 weeks (or post menstrual age 28 0/7 weeks) or higher 3. Infants who require endotracheal intubation on a non-emergent basis 4. Signed informed consent by parents Exclusion criteria: 1. intubations that occurred in the delivery room or for other emergent basis, 2. absence of intravenous access 3. abnormality of the airway 4. known or family history of neuromuscular disorder 5. renal insufficiency (urine output <0.6 mL/kg per hour or creatine >1.7 mg/dL if > 1 day of age) 6. known hepatic insufficiency (abnormal liver function or coagulation laboratory results) 7. Current diagnosis of pulmonary hypertension 8. Any infant deemed by the attending neonatologist as unstable or unfit for the study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Martin Espinosa, MD | The Gerber Foundation |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Present the Percentage of Participants With an Excellent Ease of Intubation Rating | percentage of participants with an excellent ease of intubation rating based on Scale of 1-4 (1 Being Excellent, 4 Being Poor)," | 24 hours after intubation period | |
Secondary | Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded. | 24 hours after intubation procedure |
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