Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation|
- Heart rate less than 80 BPM and oxygen saturation less than 80% [ Time Frame: 5-6 minutes ] [ Designated as safety issue: Yes ]
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)
- Heart rate < 100 BPM [ Time Frame: 5-6 minutes ] [ Designated as safety issue: Yes ]
- Oxygen saturation < 85% [ Time Frame: 5-6 minutes ] [ Designated as safety issue: Yes ]
- Duration of intubation attempts [ Time Frame: 1-2 minutes ] [ Designated as safety issue: Yes ]
- Number of intubation attempts [ Time Frame: 5-6 minutes ] [ Designated as safety issue: Yes ]
- Lowest heart rate after premedication [ Time Frame: 5-6 minutes ] [ Designated as safety issue: Yes ]
- Lowest oxygen saturation after premedication [ Time Frame: 5-6 minutes ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Atropine, fentanyl and succinylcholine
20 mcg/kg atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.
Atropine 0.02 mg/kg IV
Other Name: AtroPen
Placebo Comparator: placebo, fentanyl and succinylcholine
an equivalent volume of normal saline to atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.
an equivalent volume of normal saline to atropine IV
Other Name: 0.9% sodium chloride
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595399
|Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3A1R9|
|Principal Investigator:||Michael R Narvey, MD||University of Manitoba|