Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation

Bradycardia Clinical Trial

Official title:

Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01595399
• Other study ID #: R500458
• Status: Recruiting
• Phase: Phase 4
• First received: May 8, 2012
• Last updated: September 23, 2013
• Start date: April 2012
• Est. completion date: June 2014

Study information

• Verified date: May 2012
• Source: University of Manitoba
• Contact: Michael R Narvey, MD
• Phone: 2047872720
• Email: mnarvey[@]hsc.mb.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare heart rate in infants who receive atropine as a part of their medication before intubation to those who do not.

To be able to find out , we need to divided babies into 2 groups;

group 1 : receives atropine + sedation + muscle relaxant group 2 : receives water or saline ( placebo group) + sedation + muscle relaxant

Then we need to compare heart rate during intubation and duration of intubation between the 2 groups.

Description:

We hypothesize that premedication for intubation with fentanyl and succinylcholine alone will maintain equal stability of heart rate and oxygen saturation without a prolongation of time to completion of intubation when compared to a protocol using atropine, fentanyl and succinylcholine.

In order to answer this question we plan to undertake a prospective randomized double blinded control trial of use of atropine as an adjunct for elective intubation of infants less than 46 weeks postmenstrual age.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Months

Eligibility

Inclusion Criteria:

• Any infant (preterm and term) up to 46 weeks corrected age requiring (nonemergent) intubation.

• IV access is obtained

• Informed parental consent

Exclusion Criteria:

• Emergent intubation or need for resuscitation

• Congenital cyanotic heart disease

• Obvious airway abnormalities

• History of myopathy or family history of malignant hyperthermia or known history of phosphocholinesterase deficiency

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bradycardia
• Hypoxemia

Intervention

Drug:
• atropine
Atropine 0.02 mg/kg IV
• Placebo
an equivalent volume of normal saline to atropine IV

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate less than 80 BPM and oxygen saturation less than 80%	Heart rate and transcutaneous oxygen saturation will be monitored continuously during the procedure and data will be recorded at 3 stages; 2 minutes prior to intubation (after atropine or placebo dose); during intubation; 2 minutes after intubation (once ETT secured to face)	5-6 minutes	Yes
Secondary	Heart rate < 100 BPM		5-6 minutes	Yes
Secondary	Oxygen saturation < 85%		5-6 minutes	Yes
Secondary	Duration of intubation attempts		1-2 minutes	Yes
Secondary	Number of intubation attempts		5-6 minutes	Yes
Secondary	Lowest heart rate after premedication		5-6 minutes	Yes
Secondary	Lowest oxygen saturation after premedication		5-6 minutes	Yes