Videolaryngoscope vs Classic Laryngoscope in Teaching Neonatal Endotracheal Intubation: a Randomized Controlled Trial.
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|ClinicalTrials.gov Identifier: NCT01394783|
Recruitment Status : Completed
First Posted : July 14, 2011
Last Update Posted : November 19, 2014
|First Submitted Date ICMJE||May 31, 2011|
|First Posted Date ICMJE||July 14, 2011|
|Last Update Posted Date||November 19, 2014|
|Start Date ICMJE||July 2011|
|Primary Completion Date||June 2013 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Endotracheal intubation success rate. [ Time Frame: 5 minutes ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01394783 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Videolaryngoscope vs Classic Laryngoscope in Teaching Neonatal Endotracheal Intubation: a Randomized Controlled Trial.|
|Official Title ICMJE||Videolaryngoscope vs Classic Laryngoscope in Teaching Neonatal Endotracheal Intubation: a Randomized Controlled Trial.|
Every year thousands of neonates born in North America need extensive resuscitation which often includes endotracheal intubation (ETI). In these situations, Pediatricians assume the role of Neonatal Resuscitation Program (NRP) providers and are responsible of the ETI procedure. They acquire this skill during residency training in the Neonatal Intensive Care Unit (NICU) and the delivery room. Difficulties in performing neonatal ETI lie in the small size of the mouth and airway of the neonate, and their particular anatomy of the larynx. This limited visibility represents a challenge even for the experienced clinician. Recently, a new videolaryngoscope (VL) technique has been introduced to the adult and pediatric medical fields as described respectively by Kaplan et al. and Weiss et al. In 2009, Vanderhal et al. reported a preliminary experience in the newborn population. Video assisted intubation could be a method of choice in teaching neonatal ETI.
To the best of our knowledge, there is no human study comparing the VL to the classic laryngoscope (CL) for acquiring the skill of neonatal ETI in the NICU.
This study aims:
The hypothesis are
Consent to the study
The principal investigator will approach all pediatric residents to participate in the study. Parents of children will be approached by the principal investigator or the clinical research coordinator either antenatal or on admission to the NICU in the case of an eventual need for the infant of ETI. If the consent is made antenatally, we will insure that it is done by a different physician than the one performing the antenatal consultation.
Training to ETI
In our centre, residents learn neonatal ETI in the simulation centre at CHU Ste-Justine as first year residents when they are taught the NRP at the end of June every year, one week before starting residency training. The procedure is explained and demonstrated on a mannequin (Laerdal Neonatal Intubation Trainer) using the CL by a neonatologist and then residents practice on the same mannequin a couple of times (3-5). Further training is done in the clinical setting on real patients in an opportunistic manner. In both situations, they are supervised by a neonatologist or a senior subspecialty resident who will guide, coach and give them constructive feedback.
Residents who consent to the study will be trained to the use of the VL before randomization. This teaching session will be done similarly to the one described above. The procedure will be explained and demonstrated on a mannequin (Laerdal Neonatal Intubation Trainer) by the principal investigator using the VL and then residents will be offered to practice handling the VL and practice ETI on the same mannequin a couple of times (3-5). They will be supervised by the principal investigator who will guide, coach and give them constructive feedback. This process is to insure that residents depart with the same level of comfort (or discomfort) as the CL.
In our unit, there are about two to three residents on service at a time. When a patient needs to be intubated priority goes to the resident who is in charge of that patient. In the case where the physician in charge is the neonatologist, the subspecialty resident or the nurse practitioner than a draw is done to decide which resident will proceed to the ETI. The pediatric resident is the first person to attempt an ETI and he is allowed three attempts. If he fails, the subspecialty resident, the respiratory therapist or the neonatologist proceed with the ETI. In the case of an urgent ETI (respiratory or cardiovascular instability, resuscitation, cardiovascular arrest, etc.) or complications during attempts by the resident, the senior physician (subspecialty resident or neonatologist) will proceed with the ETI.
At each ETI procedure, there is a resident, a neonatologist or a subspecialty resident, a nurse and a respiratory therapist. For the study, we will have a second respiratory therapist to assess our primary and secondary outcomes (using a stopwatch) and to collect the necessary data. About six respiratory therapists will be trained for this role, two per 8 hour shift. Monitoring of the child is done using a non invasive arterial blood pressure, an electrocardiogram and a pulse oximeter.
The devices used for the study will be the CL using Miller blades (size 0 and 1), and the C-MAC VL (blades size 0 and 1) developed by Karl Storz Endoscopy. The VL will be used to proceed to ETI indirectly with the use of the video monitor for guidance.
Premedication for ETI consists of a bolus of atropine 20 mcg/kg IV, fentanyl 2-5 mcg/kg diluted in 1 cc total of normal saline and given IV over 3 to 5 minutes, followed by a bolus of 2 mg/kg of IV succinylcholine. Facemask ventilation and preoxygenation is done before and between every attempt. After ETI, confirmation is done by auscultation and carbon dioxide detector, and a chest x-ray is performed to assess position of the tip of the endotracheal tube.
Data collection for each intubation.
After consent, randomization will be done by distributing sealed envelopes and will be stratified according to the year of residency training. Residents will initially be randomized to intubate either with the videolaryngoscope (experimental group) or the classical laryngoscope (control group). In a second phase, all students will use the CL for ETI. Each resident is expected to perform at least five and a maximum of ten ETI per method. When a resident has reached ten ETI with the VL, he will change to the CL method. We are planning to obtain 100 ETI in each four groups for a total of 400 ETI.
Methods of data analysis and sample size estimates
Using the CL, the residents in our centre obtained a success rate of ETI of 55% (unpublished data). Assuming an increase of 20% of the success rate to 75% in the experimental group (VL), with an α level of 0.05 and a statistical power of 80%, we need 89 ETI per group. In the second phase, to show a 20% higher success rate in the experimental group (75%) than in the control group (55%) with the same statistical conditions, we need 89 more ETI per group for a total of 356 ETI. In the study, we plan to obtain 100 ETI per group for a total of 400 ETI. In our centre there are approximately 500 ETI a year. Of these, 20% (100) are done in the delivery room and another 20% (100) are done by the subspecialty resident, neonatologist or respiratory therapist because of urgency or difficulty of intubation. Considering a rate of patient recruitment of 60-75%, the study should be completed in 2 years.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
|Condition ICMJE||Intubation, Intratracheal|
|Publications *||Moussa A, Luangxay Y, Tremblay S, Lavoie J, Aube G, Savoie E, Lachance C. Videolaryngoscope for Teaching Neonatal Endotracheal Intubation: A Randomized Controlled Trial. Pediatrics. 2016 Mar;137(3):e20152156. doi: 10.1542/peds.2015-2156. Epub 2016 Feb 12.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||June 2014|
|Primary Completion Date||June 2013 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||up to 1 Year (Child)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Canada|
|Removed Location Countries|
|NCT Number ICMJE||NCT01394783|
|Other Study ID Numbers ICMJE||3282-CER|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Ahmed Moussa, St. Justine's Hospital|
|Study Sponsor ICMJE||St. Justine's Hospital|
|Collaborators ICMJE||Not Provided|
|PRS Account||St. Justine's Hospital|
|Verification Date||November 2014|
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