Premedication for Non-Emergency Endotracheal Intubation In the NICU

Respiratory Distress Syndrome Clinical Trial

Official title:

Premedication for Non-Emergency Endotracheal Intubation In the NICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749501
• Other study ID #: 2010-271
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2012
• Last updated: October 24, 2017
• Start date: January 2011
• Est. completion date: January 2014

Study information

• Verified date: October 2017
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The investigators project will study two different strategies of pre-medication in an attempt to eliminate the pain and discomfort associated with the elective intubation procedure. The study will be blinded and patients will be randomized in two different arms according to gestational age and identified by study number for pre-medication protocols. Demographic as well as study information prior, during and post intubation attempt will be recorded and closely monitored. Each patient will be monitored for study purposes for at least 24 hours after intubation attempt to record any potential side effects of the medication. The investigators plan to have a data safety monitoring board established composed of three pediatric doctors / specialists not associated with this study.

The response of paralysis, onset and duration will be assessed clinically. Onset of muscle relaxation will be described as the absence of spontaneous movements and flaccidity, measured in seconds from the end of the medication administration. Duration of paralysis will be determined by the difference in time from the onset of paralysis to the return of spontaneous movements and pre-intubation tone

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• Rocuronium
0.6 mg/Kg once

Other:
• Placebo
Normal saline same amt as 0.6mg/kg of study drug

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Martin Espinosa, MD	The Gerber Foundation

Outcome

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