Back to resultsAtropine Versus no Atropine for Neonatal Rapid Sequence Intubation
Primary Purpose
Bradycardia, Hypoxemia
Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
atropine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Bradycardia focused on measuring bradycardia, hypoxemia, intubation, premedication
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
Sites / Locations
- Health Sciences CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Atropine, fentanyl and succinylcholine
placebo, fentanyl and succinylcholine
Arm Description
20 mcg/kg atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.
an equivalent volume of normal saline to atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Heart rate < 100 BPM
Oxygen saturation < 85%
Duration of intubation attempts
Number of intubation attempts
Lowest heart rate after premedication
Lowest oxygen saturation after premedication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01595399
Brief Title
Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation
Official Title
Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia, Hypoxemia
Keywords
bradycardia, hypoxemia, intubation, premedication
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Atropine, fentanyl and succinylcholine
Arm Type
Active Comparator
Arm Description
20 mcg/kg atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.
Arm Title
placebo, fentanyl and succinylcholine
Arm Type
Placebo Comparator
Arm Description
an equivalent volume of normal saline to atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.
Intervention Type
Drug
Intervention Name(s)
atropine
Other Intervention Name(s)
AtroPen
Intervention Description
Atropine 0.02 mg/kg IV
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0.9% sodium chloride
Intervention Description
an equivalent volume of normal saline to atropine IV
Primary Outcome Measure Information:
Title
Heart rate less than 80 BPM and oxygen saturation less than 80%
Description
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)
Time Frame
5-6 minutes
Secondary Outcome Measure Information:
Title
Heart rate < 100 BPM
Time Frame
5-6 minutes
Title
Oxygen saturation < 85%
Time Frame
5-6 minutes
Title
Duration of intubation attempts
Time Frame
1-2 minutes
Title
Number of intubation attempts
Time Frame
5-6 minutes
Title
Lowest heart rate after premedication
Time Frame
5-6 minutes
Title
Lowest oxygen saturation after premedication
Time Frame
5-6 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael R Narvey, MD
Phone
2047872720
Email
mnarvey@hsc.mb.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jehier Afifi, MD
Phone
9024706944
Email
Jehier.afifi@iwk.nshealth.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R Narvey, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A1R9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Narvey, MD
Phone
2047872720
Email
mnarvey@hsc.mb.ca
First Name & Middle Initial & Last Name & Degree
Michael R Narvey, MD
First Name & Middle Initial & Last Name & Degree
Jehier Afifi, MD
First Name & Middle Initial & Last Name & Degree
John Baier, MD
12. IPD Sharing Statement
Learn more about this trial
Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation
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