Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01595399|
Recruitment Status : Unknown
Verified May 2012 by University of Manitoba.
Recruitment status was: Recruiting
First Posted : May 10, 2012
Last Update Posted : September 24, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Bradycardia Hypoxemia||Drug: atropine Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||June 2014|
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
- Heart rate less than 80 BPM and oxygen saturation less than 80% [ Time Frame: 5-6 minutes ]
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 ]
- Oxygen saturation < 85% [ Time Frame: 5-6 minutes ]
- Duration of intubation attempts [ Time Frame: 1-2 minutes ]
- Number of intubation attempts [ Time Frame: 5-6 minutes ]
- Lowest heart rate after premedication [ Time Frame: 5-6 minutes ]
- Lowest oxygen saturation after premedication [ Time Frame: 5-6 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595399
|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|