Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
For poor enrollment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Short-term Catheter Related Complications for Each Technique | Incidence of short-term catheter related complications for each technique (IO vs IV) | during emergency department stay, average time frame 24 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients in the emergency department with airway difficulties requiring rapid sequence intubation.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephen W Borron, MD | Texas Tech University Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christus Spohn Hospital Corpus Christi | Corpus Christi | Texas | 78405 | United States | ||
| Texas Tech University Health Science Center El Paso |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21856044 | Background | Reades R, Studnek JR, Vandeventer S, Garrett J. Intraosseous versus intravenous vascular access during out-of-hospital cardiac arrest: a randomized controlled trial. Ann Emerg Med. 2011 Dec;58(6):509-16. doi: 10.1016/j.annemergmed.2011.07.020. | |
| 9416711 | Background | Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous (IV) Drug Delivery | patients on whom intravenous vascular access has been established for the purpose of rapid sequence intubation drug delivery. |
| FG001 | Intraosseous (IO) Drug Delivery | Patients on whom intraosseous vascular access has been established for rapid sequence intubation drug delivery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous (IV) Drug Delivery | patients on whom intravenous vascular access has been established for the purpose of rapid sequence intubation drug delivery. |
| BG001 | Intraosseous (IO) Drug Delivery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | seconds | during rapid sequence intubation procedure, average expected time frame 30 minutes |
|
Duration of participants stay in the Emergency Department, up to 24 hours.
In this observational study only adverse events (AEs) associated with the IV or IO vascular access catheter(s) used during the rapid sequence intubation procedure were collected.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous (IV) Drug Delivery | patients on whom intravenous vascular access has been established for the purpose of rapid sequence intubation drug delivery. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tatiana Puga | Teleflex | tatiana.puga@teleflex.com |
Not provided
Not provided
Not provided
Not provided
| during rapid sequence intubation procedure, average time frame 30 minutes |
| El Paso |
| Texas |
| 79905 |
| United States |
| 21893125 | Background | Leidel BA, Kirchhoff C, Bogner V, Braunstein V, Biberthaler P, Kanz KG. Comparison of intraosseous versus central venous vascular access in adults under resuscitation in the emergency department with inaccessible peripheral veins. Resuscitation. 2012 Jan;83(1):40-5. doi: 10.1016/j.resuscitation.2011.08.017. Epub 2011 Sep 3. |
| 20956050 | Background | Deakin CD, Nolan JP, Sunde K, Koster RW. European Resuscitation Council Guidelines for Resuscitation 2010 Section 3. Electrical therapies: automated external defibrillators, defibrillation, cardioversion and pacing. Resuscitation. 2010 Oct;81(10):1293-304. doi: 10.1016/j.resuscitation.2010.08.008. No abstract available. |
| 20956433 | Background | Kleinman ME, de Caen AR, Chameides L, Atkins DL, Berg RA, Berg MD, Bhanji F, Biarent D, Bingham R, Coovadia AH, Hazinski MF, Hickey RW, Nadkarni VM, Reis AG, Rodriguez-Nunez A, Tibballs J, Zaritsky AL, Zideman D; Pediatric Basic and Advanced Life Support Chapter Collaborators. Pediatric basic and advanced life support: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Pediatrics. 2010 Nov;126(5):e1261-318. doi: 10.1542/peds.2010-2972A. Epub 2010 Oct 18. No abstract available. |
| 19325359 | Background | Brierley J, Carcillo JA, Choong K, Cornell T, Decaen A, Deymann A, Doctor A, Davis A, Duff J, Dugas MA, Duncan A, Evans B, Feldman J, Felmet K, Fisher G, Frankel L, Jeffries H, Greenwald B, Gutierrez J, Hall M, Han YY, Hanson J, Hazelzet J, Hernan L, Kiff J, Kissoon N, Kon A, Irazuzta J, Lin J, Lorts A, Mariscalco M, Mehta R, Nadel S, Nguyen T, Nicholson C, Peters M, Okhuysen-Cawley R, Poulton T, Relves M, Rodriguez A, Rozenfeld R, Schnitzler E, Shanley T, Kache S, Skippen P, Torres A, von Dessauer B, Weingarten J, Yeh T, Zaritsky A, Stojadinovic B, Zimmerman J, Zuckerberg A. Clinical practice parameters for hemodynamic support of pediatric and neonatal septic shock: 2007 update from the American College of Critical Care Medicine. Crit Care Med. 2009 Feb;37(2):666-88. doi: 10.1097/CCM.0b013e31819323c6. |
| 18082778 | Background | Von Hoff DD, Kuhn JG, Burris HA 3rd, Miller LJ. Does intraosseous equal intravenous? A pharmacokinetic study. Am J Emerg Med. 2008 Jan;26(1):31-8. doi: 10.1016/j.ajem.2007.03.024. |
| 1688484 | Background | Orlowski JP, Porembka DT, Gallagher JM, Lockrem JD, VanLente F. Comparison study of intraosseous, central intravenous, and peripheral intravenous infusions of emergency drugs. Am J Dis Child. 1990 Jan;144(1):112-7. doi: 10.1001/archpedi.1990.02150250124049. |
| 11099426 | Background | Laurin EG, Sakles JC, Panacek EA, Rantapaa AA, Redd J. A comparison of succinylcholine and rocuronium for rapid-sequence intubation of emergency department patients. Acad Emerg Med. 2000 Dec;7(12):1362-9. doi: 10.1111/j.1553-2712.2000.tb00493.x. |
| 18425883 | Background | Perry JJ, Lee JS, Sillberg VA, Wells GA. Rocuronium versus succinylcholine for rapid sequence induction intubation. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD002788. doi: 10.1002/14651858.CD002788.pub2. |
Patients on whom intraosseous vascular access has been established for rapid sequence intubation drug delivery.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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 | Posted | Mean | Standard Deviation | units on a scale | during rapid sequence intubation procedure, average expected time frame 30 minutes |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | during rapid sequence intubation procedure, average expected time frame 30 minutes |
|
|
|
| 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 | Posted | Count of Participants | Participants | during rapid sequence intubation procedure, average time frame 30 minutes |
|
|
|
| Secondary | Incidence of Short-term Catheter Related Complications for Each Technique | Incidence of short-term catheter related complications for each technique (IO vs IV) | Posted | Number | complications | during emergency department stay, average time frame 24 hours |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Intraosseous (IO) Drug Delivery | Patients on whom intraosseous vascular access has been established for rapid sequence intubation drug delivery. | 0 | 2 | 0 | 2 | 0 | 2 |
Not provided