Bradycardia, Hypoxemia
Conditions
Keywords
bradycardia, hypoxemia, intubation, premedication
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.
Interventions
DRUGatropine
Atropine 0.02 mg/kg IV
DRUGPlacebo
an equivalent volume of normal saline to atropine IV
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 2 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate less than 80 BPM and oxygen saturation less than 80% | 5-6 minutes | Heart rate and transcutaneous oxygen saturation will be monitored continuously during the procedure and data will be recorded at 3 stages; 1. 2 minutes prior to intubation (after atropine or placebo dose) 2. during intubation 3. 2 minutes after intubation (once ETT secured to face) |
Secondary
| Measure | Time frame |
|---|---|
| Oxygen saturation < 85% | 5-6 minutes |
| Duration of intubation attempts | 1-2 minutes |
| Heart rate < 100 BPM | 5-6 minutes |
| Lowest heart rate after premedication | 5-6 minutes |
| Lowest oxygen saturation after premedication | 5-6 minutes |
| Number of intubation attempts | 5-6 minutes |
Countries
Canada
Contacts
Primary ContactMichael R Narvey, MD
Backup ContactJehier Afifi, MD
Outcome results
None listed