Airway ControlNCT01634867
Rapid Sequence Intubation Drug Delivery Using Intraosseous and IV Access in Pediatric Patients Observational Study
An observational study of Airway Control, run by Vidacare Corporation at 1 site in United States.
Trial summary
This study will evaluate using intraosseous vascular access and intravenous vascular access to give pediatric patients the necessary medications to perform rapid sequence intubation, for patients with airway difficulties. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Airway Control
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients in the emergency department with airway difficulties requiring rapid sequence intubation.
Who may be able to join
- subjects requiring rapid sequence intubation for whom rocuronium is chosen as the paralytic agent.
- the operator chooses to place a peripheral intravenous or powered intraosseous catheter to permit rapid sequence intubation.
Who cannot join
- subjects in whom vascular access for rapid sequence intubation drug administration was established prior to arrival to the emergency department.
Trial locations and contacts
1 site in 1 country.
United States1 site
Omaha Children's Hospital and Medical Center
Omaha, Nebraska, 68198
About this study
Official title: A Pilot Study of Intubating Conditions Comparing Intraosseous Vascular Access With Peripheral Intravenous Access for Drug Delivery in Rapid Sequence Intubation Using Rocuronium as the Paralytic Agent
This study will evaluate using intraosseous vascular access and intravenous vascular access to give pediatric patients the necessary medications to perform rapid sequence intubation, for patients with airway difficulties.
- Conditions
- Airway Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intraosseous (IO) drug delivery | patients in whom intraosseous (IO) vascular access has been established for rapid sequence intubation drug delivery. | |
| Peripheral intravenous (IV) drug delivery | patients in whom peripheral intravenous (IV) vascular access has been established for rapid sequence intubation drug delivery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from determination of need for vascular access for rapid sequence intubation to administration of first does of paralytic agent.
Time from determination of need for vascular access for rapid sequence intubation to administration of first does of paralytic agent.
Measured: during rapid sequence intubation procedure, average expected time frame 30 minutes
Time from vascular access to intubation first attempt, as indicated by the first attempt to visualize the larynx with the laryngoscope.
Time from vascular access to intubation first attempt, as indicated by the first attempt to visualize the larynx with the laryngoscope.
Measured: during rapid sequence intubation procedure, average expected time frame 30 minutes
time from vascular access to successful intubation
time from vascular access to successful intubation
Measured: during rapid sequence intubation procedure, average expected time frame 30 minutes
number of attempts necessary for successful intubation
number of attempts necessary for successful intubation
Measured: during rapid sequence intubation procedure, average expected time frame 30 minutes
Secondary outcomes (5)
Intubation difficulty
The Intubation Difficulty Scale is a validated tool used to grade the difficulty with which a patient was intubated for airway managment during rapid sequence intubation.
Measured: during rapid sequence intubation procedure, average time frame 30 minutes
operator satisfaction with intubating conditions
operator satisfaction with intubating conditions
Measured: during rapid sequence intubation procedure, average time frame 30 minutes
failure rate of endotracheal intubation
failure rate of endotracheal intubation and requirement for alternative airway management.
Measured: during rapid sequence intubation procedure, average time frame 30 minutes
Time from presentation of patient to vascular access established
Time from presentation of patient to vascular access established
Measured: during rapid sequence intubation procedure, average time frame 30 minutes
Determine the incidence of short term catheter related complications for each technique
Determine the incidence of short term catheter related complications for each technique
Measured: during emergency department stay, average time frame 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: No subject enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Airway ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vidacare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Truemper, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634867
- Sponsor's protocol ID
- 2012-03
- Status last verified
- Dec 2014
- First submitted
- 2 Jul 2012
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21856044Adnet 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.
PubMed 9416711Leidel 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.
PubMed 21893125Deakin CD, Nolan JP, Soar J, Sunde K, Koster RW, Smith GB, Perkins GD. European Resuscitation Council Guidelines for Resuscitation 2010 Section 4. Adult advanced life support. Resuscitation. 2010 Oct;81(10):1305-52. doi: 10.1016/j.resuscitation.2010.08.017. No abstract available.
PubMed 20956049Kleinman 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. Part 10: Pediatric basic and advanced life support: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2010 Oct 19;122(16 Suppl 2):S466-515. doi: 10.1161/CIRCULATIONAHA.110.971093.
PubMed 20956258Brierley 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.
PubMed 19325359Von 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.
PubMed 18082778Orlowski 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.
PubMed 1688484Laurin 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.
PubMed 11099426Perry 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.
PubMed 18425883
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Intubating Conditions Comparing Intraosseous Vascular Access With Peripheral Intravenous Access for Drug Delivery in Rapid Sequence Intubation Using Rocuronium as the Paralytic Agent
- ClinicalTrials.gov ID
- NCT01634867
- Acronym / sponsor ID
- 2012-03
- Conditions
- Airway Control
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No subject enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vidacare CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 6 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate using intraosseous vascular access and intravenous vascular access to give pediatric patients the necessary medications to perform rapid sequence intubation, for patients with airway difficulties.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraosseous (IO) drug delivery | – | –patients in whom intraosseous (IO) vascular access has been established for rapid sequence intubation drug delivery. |
| Peripheral intravenous (IV) drug delivery | – | –patients in whom peripheral intravenous (IV) vascular access has been established for rapid sequence intubation drug delivery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients in the emergency department with airway difficulties requiring rapid sequence intubation.
Key inclusion criteria (2 listed)
- subjects requiring rapid sequence intubation for whom rocuronium is chosen as the paralytic agent.
- the operator chooses to place a peripheral intravenous or powered intraosseous catheter to permit rapid sequence intubation.
Key exclusion criteria (1 listed)
- subjects in whom vascular access for rapid sequence intubation drug administration was established prior to arrival to the emergency department.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time from determination of need for vascular access for rapid sequence intubation to administration of first does of paralytic agent.
Time frame: during rapid sequence intubation procedure, average expected time frame 30 minutes
Time from determination of need for vascular access for rapid sequence intubation to administration of first does of paralytic agent.
Time from vascular access to intubation first attempt, as indicated by the first attempt to visualize the larynx with the laryngoscope.
Time frame: during rapid sequence intubation procedure, average expected time frame 30 minutes
Time from vascular access to intubation first attempt, as indicated by the first attempt to visualize the larynx with the laryngoscope.
time from vascular access to successful intubation
Time frame: during rapid sequence intubation procedure, average expected time frame 30 minutes
time from vascular access to successful intubation
number of attempts necessary for successful intubation
Time frame: during rapid sequence intubation procedure, average expected time frame 30 minutes
number of attempts necessary for successful intubation
5 secondary outcomes
Intubation difficulty
Time frame: during rapid sequence intubation procedure, average time frame 30 minutes
operator satisfaction with intubating conditions
Time frame: during rapid sequence intubation procedure, average time frame 30 minutes
failure rate of endotracheal intubation
Time frame: during rapid sequence intubation procedure, average time frame 30 minutes
Time from presentation of patient to vascular access established
Time frame: during rapid sequence intubation procedure, average time frame 30 minutes
Determine the incidence of short term catheter related complications for each technique
Time frame: during emergency department stay, average time frame 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Background: PubMed 21856044Reades 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.
- Background: PubMed 9416711Adnet 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.
- Background: PubMed 21893125Leidel 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.
- Background: PubMed 20956049Deakin CD, Nolan JP, Soar J, Sunde K, Koster RW, Smith GB, Perkins GD. European Resuscitation Council Guidelines for Resuscitation 2010 Section 4. Adult advanced life support. Resuscitation. 2010 Oct;81(10):1305-52. doi: 10.1016/j.resuscitation.2010.08.017. No abstract available.
- Background: PubMed 20956258Kleinman 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. Part 10: Pediatric basic and advanced life support: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2010 Oct 19;122(16 Suppl 2):S466-515. doi: 10.1161/CIRCULATIONAHA.110.971093.
- Background: PubMed 19325359Brierley 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.
- Background: PubMed 18082778Von 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.
- Background: PubMed 1688484Orlowski 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.
- Background: PubMed 11099426Laurin 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.
- Background: PubMed 18425883Perry 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Truemper, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Control, run by Vidacare Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from determination of need for vascular access for rapid sequence intubation to administration of first does of paralytic agent. (time frame: during rapid sequence intubation procedure, average expected time frame 30 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01634867, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.