Trial Outcomes & Findings for Observational Study of Rapid Sequence Intubation Drug Delivery Using Intraosseous and Intravenous Access. (NCT NCT01486407)
NCT ID: NCT01486407
Last Updated: 2026-01-08
Results Overview
Time measured in seconds from first drug delivery to the time of operator-perceived sufficient relaxation to perform endotracheal tube placement
TERMINATED
4 participants
during rapid sequence intubation procedure, average expected time frame 30 minutes
2026-01-08
Participant Flow
Participant milestones
| Measure |
Intravenous (IV) Drug Delivery
patients on whom intravenous vascular access has been established for the purpose of rapid sequence intubation drug delivery.
|
Intraosseous (IO) Drug Delivery
Patients on whom intraosseous vascular access has been established for rapid sequence intubation drug delivery.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intravenous (IV) Drug Delivery
n=2 Participants
patients on whom intravenous vascular access has been established for the purpose of rapid sequence intubation drug delivery.
|
Intraosseous (IO) Drug Delivery
n=2 Participants
Patients on whom intraosseous vascular access has been established for rapid sequence intubation drug delivery.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 6.36 • n=2 Participants
|
41 years
STANDARD_DEVIATION 56.57 • n=2 Participants
|
40.25 years
STANDARD_DEVIATION 32.88 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
2 participants
n=2 Participants
|
2 participants
n=2 Participants
|
4 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: during rapid sequence intubation procedure, average expected time frame 30 minutesTime measured in seconds from first drug delivery to the time of operator-perceived sufficient relaxation to perform endotracheal tube placement
Outcome measures
| Measure |
Intravenous (IV) Drug Delivery
n=2 Participants
patients on whom intravenous vascular access has been established for the purpose of rapid sequence intubation drug delivery.
|
Intraosseous (IO) Drug Delivery
n=2 Participants
Patients on whom intraosseous vascular access has been established for rapid sequence intubation drug delivery.
|
|---|---|---|
|
Time From First Drug Delivery to Operator-perceived Sufficient Relaxation to Perform Endotracheal Tube Placement
|
62.5 seconds
Standard Deviation 2.12
|
45 seconds
Standard Deviation 21.21
|
PRIMARY outcome
Timeframe: during rapid sequence intubation procedure, average expected time frame 30 minutesIntubation Difficulty Scale (IDS) provides a numerical Total score describing the difficulty of the intubation procedure based upon the summation of the following individual sub-scores: number of attempts (each additional attempt adds (+)1 point, minimum score=0, no maximum), number of operators (each additional +1 point, minimum score=0, no maximum), use of alternative techniques (each alternative technique +1 point, minimum score=0, no maximum), cormack grade for first oral attempt (measures the quality of the view of the larynx using grades 1 - 4 where higher number means poorer visibility; successful blind intubation=0. minimum score=0, maximum=4), lifting force required (normal=0 or increased=1), laryngeal pressure (not applied=0 or applied=1), vocal cord mobility (abduction=0 or adduction=1). Total IDS minimum score=0, no maximum score. Score 0=Easy; Score 1 - 5 =slight difficulty; Score \>5 =moderate to major difficulty Score infinite =Failed/Impossible intubation
Outcome measures
| Measure |
Intravenous (IV) Drug Delivery
n=2 Participants
patients on whom intravenous vascular access has been established for the purpose of rapid sequence intubation drug delivery.
|
Intraosseous (IO) Drug Delivery
n=2 Participants
Patients on whom intraosseous vascular access has been established for rapid sequence intubation drug delivery.
|
|---|---|---|
|
Intubation Difficulty Scale
|
1.5 units on a scale
Standard Deviation 0.71
|
2 units on a scale
Standard Deviation 1.41
|
PRIMARY outcome
Timeframe: during rapid sequence intubation procedure, average expected time frame 30 minutesOperator reported level of satisfaction with intubating conditions regarding adequacy of sedation and adequacy of muscular relaxation. This is reported using a 100 mm visual analog scale from 0 - 100 where higher numbers indicate greater satisfaction.
Outcome measures
| Measure |
Intravenous (IV) Drug Delivery
n=2 Participants
patients on whom intravenous vascular access has been established for the purpose of rapid sequence intubation drug delivery.
|
Intraosseous (IO) Drug Delivery
n=2 Participants
Patients on whom intraosseous vascular access has been established for rapid sequence intubation drug delivery.
|
|---|---|---|
|
Operator Satisfaction With Intubating Conditions Using Visual Analog Scale
|
95.75 units on a scale
Standard Deviation 6.01
|
92.25 units on a scale
Standard Deviation 0.35
|
PRIMARY outcome
Timeframe: during rapid sequence intubation procedure, average time frame 30 minutesFailure rate of endotracheal intubation and requirement for alternative airway management methods
Outcome measures
| Measure |
Intravenous (IV) Drug Delivery
n=2 Participants
patients on whom intravenous vascular access has been established for the purpose of rapid sequence intubation drug delivery.
|
Intraosseous (IO) Drug Delivery
n=2 Participants
Patients on whom intraosseous vascular access has been established for rapid sequence intubation drug delivery.
|
|---|---|---|
|
Failure Rate of Endotracheal Intubation and Requirement for Alternative Airway Management Methods
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: during emergency department stay, average time frame 24 hoursIncidence of short-term catheter related complications for each technique (IO vs IV)
Outcome measures
| Measure |
Intravenous (IV) Drug Delivery
n=2 Participants
patients on whom intravenous vascular access has been established for the purpose of rapid sequence intubation drug delivery.
|
Intraosseous (IO) Drug Delivery
n=2 Participants
Patients on whom intraosseous vascular access has been established for rapid sequence intubation drug delivery.
|
|---|---|---|
|
Incidence of Short-term Catheter Related Complications for Each Technique
|
0 complications
|
0 complications
|
Adverse Events
Intravenous (IV) Drug Delivery
Intraosseous (IO) Drug Delivery
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60