|- candidate number||25385|
|- NTR Number||NTR6174|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-okt-2016|
|- Secondary IDs||MEC-2015-467 (METC Erasmus MC) |
|- Public Title||Video-assisted Intubations in the Prehospital Setting (VIPS)|
|- Scientific Title||Video-assisted Intubations in the Prehospital Setting (VIPS)|
|- hypothesis||We expect that video-assisted intubation (video laryngoscopy) by ambulance nurses will have a higher success rate than intubation with a classical intubation device (direct laryngoscopy). |
|- Healt Condition(s) or Problem(s) studied||Resuscitation, Intubation|
|- Inclusion criteria||1. Patient requiring endotracheal intubation |
2. GCS of 3 points, without suspected neurological injuries
3. Estimated age 18 years or older
|- Exclusion criteria||1. No CO2 production visible on capnogram, or no capnogram available|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-jan-2016|
|- planned closingdate||31-dec-2017|
|- Target number of participants||500|
|- Interventions||Videolaryngoscopy versus direct laryngoscopy|
|- Primary outcome||First-time success|
|- Secondary outcome||- Second-attempt success|
- Time required for intubation
- Adverse events
|- Timepoints||On-scene, immediately after intubation|
|- Trial web site||None|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD PhD M.H.J. Verhofstad|
|- CONTACT for SCIENTIFIC QUERIES||MD PhD M.H.J. Verhofstad|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam, Erasmus MC, Trauma Research Unit department of Surgery, AmbulanceZorg Rotterdam Rijnmond|
(Source(s) of Monetary or Material Support)
|- Publications||None yet; study is ongoing|
|- Brief summary||BACKGROUND|
Literature shows that the rate of first-time success of emergency endotracheal intubation by ambulance nurses is highly variable; rates between 46 and 95% have been reported. Due to differences in device design, we hypothesize that the rate of first-time success can be improved when using videolaryngoscopy instead of direct laryngoscopy.
The primary aim of this prospective, observational study is to compare the rate of first-time success of intubation (by ambulance nurses) using videolaryngoscopy versus direct laryngoscopy. Secondary aims are to assess the rate of second-attempt success, time required for intubation, rate of adverse events, and rate of ROSC after videolaryngoscopy versus direct laryngoscopy, performed by ambulance nurses.
Patients requiring emergency endotracheal intubation.
Primary outcome measure: first-time success.
Secondary outcome measures: second-attempt success, time required for intubation, adverse events, and ROSC.
Primary and secondary outcomes will be determined on-scene immediately after intubation.
|- Main changes (audit trail)|
|- RECORD||10-okt-2016 - 8-jan-2018|