Respiratory Failure
Conditions
Keywords
intubation, laryngoscopy, prehospital, emergency medical services
Brief summary
The goal of this study is to compare the first pass success rate of intubation between video assisted intubation and traditional direct visualization intubation in the field by Emergency Medical Service (EMS) professionals
Detailed description
We will equip several local advanced life support ambulances with a low cost video laryngoscope for a total of 12 months. We will outfit ½ of the ambulance crews with the King Video Laryngoscope (KVL) for 6 months while the other ½ of the ambulances will use traditional direct laryngoscopy (DL). After 6 months, the groups will switch devices. We will randomly assign those ambulances that first use the KVL. After one year (12 months) we will compare the outcomes between the two methods including first pass intubation success, total success rate for intubation, and complications (need for surgical airway, rescue device, need to revert from KVL to DL, etc.). Please see the attached protocol page for additional details.
Interventions
DEVICEKing Video Laryngoscope
We will outfit ½ of the ambulance crews with the King Video Laryngoscope (KVL) for 6 months while the other ½ of the ambulances will use traditional direct laryngoscopy (DL). After 6 months, the groups will switch devices. We will randomly assign those ambulances that first use the KVL. After one year (12 months) we will compare the outcomes between the two methods.
DEVICEtraditional direct laryngoscopy (DL)
Sponsors
Saint Vincent Hospital, Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* all patients \>= age 18 year of age undergoing ETI in the prehospital setting
Exclusion criteria
* age \< 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful First Intubation Attempt (First Pass Attempt) | less than 24 hours, collected for the duration of the study (approximately 34 months) | Endotracheal Intubation (ETI) attempt will be defined as tip of the laryngoscope blade passing the patient's lips. First attempt success rate will be defined as the number of successful placements occurring on the first attempt to place the endotracheal tube. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Success | up to 24 hours, duration of the study (approximately 34 months) | Overall success rate will be defined as the total number of successful placements divided by the total number of patients treated. |
Countries
United States
Participant flow
Pre-assignment details
83 were enrolled and 82 met inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Video Laryngoscopy Treatment Patients treated by ambulance agency with video laryngoscopy. | 40 |
| Direct Laryngoscopy Treatment Patients treated by ambulance agency with direct laryngoscopy. | 42 |
| Total | 82 |
Baseline characteristics
| Characteristic | Video Laryngoscopy Treatment | Direct Laryngoscopy Treatment | Total |
|---|---|---|---|
| Age, Customized Age 18-59 | 11 Participants | 13 Participants | 24 Participants |
| Age, Customized Age 60 and over | 29 Participants | 29 Participants | 58 Participants |
| Sex: Female, Male Female | 12 Participants | 9 Participants | 21 Participants |
| Sex: Female, Male Male | 28 Participants | 33 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 42 |
| serious Total, serious adverse events | 0 / 40 | 0 / 42 |
Outcome results
Primary
Number of Participants With Successful First Intubation Attempt (First Pass Attempt)
Endotracheal Intubation (ETI) attempt will be defined as tip of the laryngoscope blade passing the patient's lips. First attempt success rate will be defined as the number of successful placements occurring on the first attempt to place the endotracheal tube.
Time frame: less than 24 hours, collected for the duration of the study (approximately 34 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Video Laryngoscopy | Number of Participants With Successful First Intubation Attempt (First Pass Attempt) | 25 Participants |
| Direct Laryngoscopy | Number of Participants With Successful First Intubation Attempt (First Pass Attempt) | 28 Participants |
Secondary
Overall Success
Overall success rate will be defined as the total number of successful placements divided by the total number of patients treated.
Time frame: up to 24 hours, duration of the study (approximately 34 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Video Laryngoscopy | Overall Success | 29 Participants |
| Direct Laryngoscopy | Overall Success | 34 Participants |