Airway Control
Conditions
Keywords
Airway management
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Vidacare Corporation
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Requires rapid sequence intubation * Succinylcholine is chosen paralytic agent * Intravenous (IV) or Intraosseous (IO) access has been established for rapid sequence intubation * For IV access patients, their rapid sequence intubation case is the next occurring IV rapid sequence intubation case following an enrolled IO Rapid Sequence Intubation (RSI) case.
Exclusion criteria
* Vascular access other than IV or IO has been established
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From First Drug Delivery to Operator-perceived Sufficient Relaxation to Perform Endotracheal Tube Placement | 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 |
| Intubation Difficulty Scale | 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 |
| Operator Satisfaction With Intubating Conditions Using Visual Analog Scale | 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. |
| Failure Rate of Endotracheal Intubation and Requirement for Alternative Airway Management Methods | during rapid sequence intubation procedure, average time frame 30 minutes | Failure rate of endotracheal intubation and requirement for alternative airway management methods |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Short-term Catheter Related Complications for Each Technique | during emergency department stay, average time frame 24 hours | Incidence of short-term catheter related complications for each technique (IO vs IV) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intravenous (IV) Drug Delivery patients on whom intravenous vascular access has been established for the purpose of rapid sequence intubation drug delivery. | 2 |
| Intraosseous (IO) Drug Delivery Patients on whom intraosseous vascular access has been established for rapid sequence intubation drug delivery. | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | Intraosseous (IO) Drug Delivery | Total | Intravenous (IV) Drug Delivery |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Continuous | 41 years STANDARD_DEVIATION 56.57 | 40.25 years STANDARD_DEVIATION 32.88 | 39.5 years STANDARD_DEVIATION 6.36 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 2 participants | 4 participants | 2 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous (IV) Drug Delivery | Failure Rate of Endotracheal Intubation and Requirement for Alternative Airway Management Methods | 0 Participants |
| Intraosseous (IO) Drug Delivery | Failure Rate of Endotracheal Intubation and Requirement for Alternative Airway Management Methods | 0 Participants |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous (IV) Drug Delivery | Intubation Difficulty Scale | 1.5 units on a scale | Standard Deviation 0.71 |
| Intraosseous (IO) Drug Delivery | Intubation Difficulty Scale | 2 units on a scale | Standard Deviation 1.41 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous (IV) Drug Delivery | Operator Satisfaction With Intubating Conditions Using Visual Analog Scale | 95.75 units on a scale | Standard Deviation 6.01 |
| Intraosseous (IO) Drug Delivery | Operator Satisfaction With Intubating Conditions Using Visual Analog Scale | 92.25 units on a scale | Standard Deviation 0.35 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous (IV) Drug Delivery | Time From First Drug Delivery to Operator-perceived Sufficient Relaxation to Perform Endotracheal Tube Placement | 62.5 seconds | Standard Deviation 2.12 |
| Intraosseous (IO) Drug Delivery | Time From First Drug Delivery to Operator-perceived Sufficient Relaxation to Perform Endotracheal Tube Placement | 45 seconds | Standard Deviation 21.21 |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intravenous (IV) Drug Delivery | Incidence of Short-term Catheter Related Complications for Each Technique | 0 complications |
| Intraosseous (IO) Drug Delivery | Incidence of Short-term Catheter Related Complications for Each Technique | 0 complications |