Airway ControlNCT01486407

Observational Study of Rapid Sequence Intubation Drug Delivery Using Intraosseous and Intravenous Access.

An observational study of Airway Control, run by Vidacare Corporation at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. 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: 4 participants
Where: 2 sitesUnited States
Study dates: Feb 2012to Dec 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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.

Who cannot join

Vascular access other than IV or IO has been established

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Christus Spohn Hospital Corpus Christi
Corpus Christi, Texas, 78405
Texas Tech University Health Science Center El Paso
El Paso, Texas, 79905

Other trials in United States

About this study

Official title: An Observational Study of Intubating Conditions Comparing Intraosseous Vascular Access With Peripheral Intravenous Access for Drug Delivery in Rapid Sequence Intubation

Read the 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.

Conditions: Airway Control
Keywords: Airway management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01486407
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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.
Measured: 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
Measured: during rapid sequence intubation procedure, average time frame 30 minutes

Secondary outcomes (1)

Incidence of Short-term Catheter Related Complications for Each Technique
Incidence of short-term catheter related complications for each technique (IO vs IV)
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.

Feb 2012Dec 2012

First posted6 Dec 2011 (estimated)
Study startFeb 2012
Primary completionDec 2012
Study completionDec 2012

Why it stopped: For poor enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01486407
Sponsor's protocol ID: 2011-13
Status last verified: Dec 2025
First submitted: 2 Dec 2011
Last updated: 8 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
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 21856044
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.
PubMed 9416711
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.
PubMed 21893125
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.
PubMed 20956050
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.
PubMed 20956433
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.
PubMed 19325359
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.
PubMed 18082778
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.
PubMed 1688484
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.
PubMed 11099426
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.
PubMed 18425883

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Airway Control trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational Study of Intubating Conditions Comparing Intraosseous Vascular Access With Peripheral Intravenous Access for Drug Delivery in Rapid Sequence Intubation
ClinicalTrials.gov ID: NCT01486407
Acronym / sponsor ID: 2011-13
Conditions: Airway Control
Keywords: Airway management
Study type: Observational
Recruitment status: TerminatedReason stopped: For poor enrollment
Enrolment: 4 participants (actual)
Lead sponsor: Vidacare CorporationIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 6 Dec 2011 (estimated)
Results: Posted 8 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
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.

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 (4 listed)

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.

Key exclusion criteria (1 listed)

Vascular access other than IV or IO has been established

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 First Drug Delivery to Operator-perceived Sufficient Relaxation to Perform Endotracheal Tube Placement
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: during rapid sequence intubation procedure, average time frame 30 minutes
Failure rate of endotracheal intubation and requirement for alternative airway management methods

1 secondary outcome

Incidence of Short-term Catheter Related Complications for Each Technique
Time frame: during emergency department stay, average time frame 24 hours

Results and safety

Results posted to the registry on 8 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intravenous (IV) Drug Delivery	2	2
Intraosseous (IO) Drug Delivery	2	2

Primary outcome: Time From First Drug Delivery to Operator-perceived Sufficient Relaxation to Perform Endotracheal Tube Placement

Time frame: during rapid sequence intubation procedure, average expected time frame 30 minutes. Mean (Standard Deviation). Unit: seconds

Measure	Intravenous (IV) Drug Delivery n = 2	Intraosseous (IO) Drug Delivery n = 2
Value	62.5 (2.12)	45 (21.21)

Primary outcome: Intubation Difficulty Scale

Time frame: during rapid sequence intubation procedure, average expected time frame 30 minutes. Mean (Standard Deviation). Unit: units on a scale

Measure	Intravenous (IV) Drug Delivery n = 2	Intraosseous (IO) Drug Delivery n = 2
Value	1.5 (0.71)	2 (1.41)

Primary outcome: Operator Satisfaction With Intubating Conditions Using Visual Analog Scale

Time frame: during rapid sequence intubation procedure, average expected time frame 30 minutes. Mean (Standard Deviation). Unit: units on a scale

Measure	Intravenous (IV) Drug Delivery n = 2	Intraosseous (IO) Drug Delivery n = 2
Value	95.75 (6.01)	92.25 (0.35)

Primary outcome: Failure Rate of Endotracheal Intubation and Requirement for Alternative Airway Management Methods

Time frame: during rapid sequence intubation procedure, average time frame 30 minutes. Count of participants. Unit: Participants

Measure	Intravenous (IV) Drug Delivery n = 2	Intraosseous (IO) Drug Delivery n = 2
Value	0	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Duration of participants stay in the Emergency Department, up to 24 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intravenous (IV) Drug Delivery	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Intraosseous (IO) Drug Delivery	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 20956050Deakin 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.
Background: PubMed 20956433Kleinman 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.
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.

Stephen W Borron, MD principal investigator

Texas Tech University Health Sciences Center

2 sites 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 2 sites 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 4 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: stopped early, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 8 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 First Drug Delivery to Operator-perceived Sufficient Relaxation to Perform Endotracheal Tube Placement (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 NCT01486407, 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 8 Jan 2026.