Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation

Conditions
-----------------
Bradycardia, Hypoxemia

Intervention / Treatment
-----------------
* Drug: atropine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 2 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atropine, fentanyl and succinylcholine<br>20 mcg/kg atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV. | Drug: atropine<br>* Atropine 0.02 mg/kg IV<br>* Other names: AtroPen;|
| Placebo Comparator: placebo, fentanyl and succinylcholine<br>an equivalent volume of normal saline to atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV. | Drug: Placebo<br>* an equivalent volume of normal saline to atropine IV<br>* Other names: 0.9% sodium chloride;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate < 100 BPM |  | 5-6 minutes | 
| Oxygen saturation < 85% |  | 5-6 minutes | 
| Duration of intubation attempts |  | 1-2 minutes | 
| Number of intubation attempts |  | 5-6 minutes | 
| Lowest heart rate after premedication |  | 5-6 minutes | 
| Lowest oxygen saturation after premedication |  | 5-6 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bradycardia, hypoxemia, intubation, premedication