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

Recruitment status

TERMINATED

Target enrollment

4 participants

Primary outcome timeframe

during rapid sequence intubation procedure, average expected time frame 30 minutes

Results posted on

2026-01-08

Participant Flow

Participant milestones

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

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 minutes

Time measured in seconds from first drug delivery to the time of operator-perceived sufficient relaxation to perform endotracheal tube placement

Outcome measures

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 minutes

Intubation 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

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 minutes

Operator 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

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 minutes

Failure rate of endotracheal intubation and requirement for alternative airway management methods

Outcome measures

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 hours

Incidence of short-term catheter related complications for each technique (IO vs IV)

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Intraosseous (IO) Drug Delivery

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tatiana Puga

Teleflex

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60