Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation
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.
|Contact: Michael R Narvey, MDfirstname.lastname@example.org|
|Contact: Jehier Afifi, MD||9024706944||Jehier.email@example.com|
|Health Sciences Centre||Recruiting|
|Winnipeg, Manitoba, Canada, R3A1R9|
|Contact: Michael Narvey, MD 2047872720 firstname.lastname@example.org|
|Principal Investigator: Michael R Narvey, MD|
|Sub-Investigator: Jehier Afifi, MD|
|Sub-Investigator: John Baier, MD|
|Principal Investigator:||Michael R Narvey, MD||University of Manitoba|