An observational study in Airway Control, sponsored by Vidacare Corporation. Terminated at 2 sites in United States. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Vidacare Corporation · Observational
This study will evaluate using intraosseous vascular access and intravenous vascular access to give patients the necessary medications to perform rapid sequence intubation, for patients with airway difficulties. The investigators think the device operator will find the intraosseous and intravenous routes equal for drug delivery.
This observational study will evaluate the intubating conditions of patients receiving rapid sequence intubation when receiving paralytic drug delivery via intravenous or intraosseous vascular access from the perspective of the medical professional performing rapid sequence intubation. The investigators believe that medical professionals will find equal intubating conditions for intravenous and intraosseous drug delivery.
Vidacare Corporation is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients in the emergency department with airway difficulties requiring rapid sequence intubation.
Exclusion Criteria:
patients on whom intravenous vascular access has been established for the purpose of rapid sequence intubation drug delivery.
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
Time measured in seconds from first drug delivery to the time of operator-perceived sufficient relaxation to perform endotracheal tube placement
Time frame: during rapid sequence intubation procedure, average expected time frame 30 minutes
Intubation Difficulty Scale
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
Time frame: during rapid sequence intubation procedure, average expected time frame 30 minutes
Operator Satisfaction With Intubating Conditions Using Visual Analog Scale
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.
Time frame: during rapid sequence intubation procedure, average expected time frame 30 minutes
Failure Rate of Endotracheal Intubation and Requirement for Alternative Airway Management Methods
Failure rate of endotracheal intubation and requirement for alternative airway management methods
Time frame: during rapid sequence intubation procedure, average time frame 30 minutes
Incidence of Short-term Catheter Related Complications for Each Technique
Incidence of short-term catheter related complications for each technique (IO vs IV)
Time frame: during emergency department stay, average time frame 24 hours
| Milestone | Intravenous (IV) Drug Delivery | Intraosseous (IO) Drug Delivery |
|---|---|---|
| Started | 2 | 2 |
| Completed | 2 | 2 |
| Not completed | 0 | 0 |
Time measured in seconds from first drug delivery to the time of operator-perceived sufficient relaxation to perform endotracheal tube placement
| seconds | Intravenous (IV) Drug Delivery | Intraosseous (IO) Drug Delivery |
|---|---|---|
| Time From First Drug Delivery to Operator-perceived Sufficient Relaxation to Perform Endotracheal Tube Placement | 62.5 ± 2.12 | 45 ± 21.21 |
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
| units on a scale | Intravenous (IV) Drug Delivery | Intraosseous (IO) Drug Delivery |
|---|---|---|
| Intubation Difficulty Scale | 1.5 ± 0.71 | 2 ± 1.41 |
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.
| units on a scale | Intravenous (IV) Drug Delivery | Intraosseous (IO) Drug Delivery |
|---|---|---|
| Operator Satisfaction With Intubating Conditions Using Visual Analog Scale | 95.75 ± 6.01 | 92.25 ± 0.35 |
Failure rate of endotracheal intubation and requirement for alternative airway management methods
| Participants | Intravenous (IV) Drug Delivery | Intraosseous (IO) Drug Delivery |
|---|---|---|
| Failure Rate of Endotracheal Intubation and Requirement for Alternative Airway Management Methods | 0 | 0 |
Incidence of short-term catheter related complications for each technique (IO vs IV)
| complications | Intravenous (IV) Drug Delivery | Intraosseous (IO) Drug Delivery |
|---|---|---|
| Incidence of Short-term Catheter Related Complications for Each Technique | 0 | 0 |
Collected over Duration of participants stay in the Emergency Department, up to 24 hours.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intravenous (IV) Drug Delivery | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Intraosseous (IO) Drug Delivery | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Intravenous (IV) Drug Delivery | Intraosseous (IO) Drug Delivery | Total |
|---|---|---|---|
| <=18 years | 0 | 1 | 1 |
| Between 18 and 65 years | 2 | 0 | 2 |
| >=65 years | 0 | 1 | 1 |
| Age, Continuous(years) | Intravenous (IV) Drug Delivery | Intraosseous (IO) Drug Delivery | Total |
|---|---|---|---|
| Mean | 39.5 ± 6.36 | 41 ± 56.57 | 40.25 ± 32.88 |
| Sex: Female, Male(Participants) | Intravenous (IV) Drug Delivery | Intraosseous (IO) Drug Delivery | Total |
|---|---|---|---|
| Female | 0 | 2 | 2 |
| Male | 2 | 0 | 2 |
| Race and Ethnicity Not Collected(Participants) | Intravenous (IV) Drug Delivery | Intraosseous (IO) Drug Delivery | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Intravenous (IV) Drug Delivery | Intraosseous (IO) Drug Delivery | Total |
|---|---|---|---|
| United States | 2 | 2 | 4 |
This study is terminated, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Vidacare Corporation