Trial Outcomes & Findings for King Video Laryngoscope Versus Direct Laryngoscopy for Prehospital Intubation: A Randomized Controlled Trial (NCT NCT02208349)
NCT ID: NCT02208349
Last Updated: 2018-06-06
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
83 participants
Primary outcome timeframe
less than 24 hours, collected for the duration of the study (approximately 34 months)
Results posted on
2018-06-06
Participant Flow
83 were enrolled and 82 met inclusion criteria.
Unit of analysis: Ambulance
Participant milestones
| Measure |
Video Laryngoscopy First Then Direct Laryngoscopy
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.
King 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.
|
Direct Laryngoscopy First Then Video Laryngoscopy
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.
traditional direct laryngoscopy (DL)
|
|---|---|---|
|
Initial 6 Months
STARTED
|
16 3
|
9 3
|
|
Initial 6 Months
COMPLETED
|
16 3
|
9 3
|
|
Initial 6 Months
NOT COMPLETED
|
0 0
|
0 0
|
|
Second 6 Months
STARTED
|
11 3
|
7 3
|
|
Second 6 Months
COMPLETED
|
11 3
|
7 3
|
|
Second 6 Months
NOT COMPLETED
|
0 0
|
0 0
|
|
Third 6 Month
STARTED
|
6 3
|
3 3
|
|
Third 6 Month
COMPLETED
|
6 3
|
3 3
|
|
Third 6 Month
NOT COMPLETED
|
0 0
|
0 0
|
|
Fourth 6 Month
STARTED
|
14 3
|
2 3
|
|
Fourth 6 Month
COMPLETED
|
14 3
|
2 3
|
|
Fourth 6 Month
NOT COMPLETED
|
0 0
|
0 0
|
|
Fifth 6 Month
STARTED
|
7 3
|
2 3
|
|
Fifth 6 Month
COMPLETED
|
7 3
|
2 3
|
|
Fifth 6 Month
NOT COMPLETED
|
0 0
|
0 0
|
|
Sixth 6 Month
STARTED
|
3 3
|
2 3
|
|
Sixth 6 Month
COMPLETED
|
3 3
|
2 3
|
|
Sixth 6 Month
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
King Video Laryngoscope Versus Direct Laryngoscopy for Prehospital Intubation: A Randomized Controlled Trial
Baseline characteristics by cohort
| Measure |
Video Laryngoscopy Treatment
n=40 Participants
Patients treated by ambulance agency with video laryngoscopy.
|
Direct Laryngoscopy Treatment
n=42 Participants
Patients treated by ambulance agency with direct laryngoscopy.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age 18-59
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Customized
Age 60 and over
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Video Laryngoscopy
n=40 Participants
Participants who were treated by an ambulance agency randomized to received VL
|
Direct Laryngoscopy
n=42 Participants
Participants who were treated by an ambulance agency randomized to receive DL
|
|---|---|---|
|
Number of Participants With Successful First Intubation Attempt (First Pass Attempt)
|
25 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Video Laryngoscopy
n=40 Participants
Participants who were treated by an ambulance agency randomized to received VL
|
Direct Laryngoscopy
n=42 Participants
Participants who were treated by an ambulance agency randomized to receive DL
|
|---|---|---|
|
Overall Success
|
29 Participants
|
34 Participants
|
Adverse Events
Video Laryngoscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Direct Laryngoscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Video Laryngoscopy
n=40 participants at risk
Patients treated by an ambulance agency randomized to VL
|
Direct Laryngoscopy
n=42 participants at risk
Patients treated by an ambulance agency randomized to DL
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Esophageal Intubation
|
0.00%
0/40
|
0.00%
0/42
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place