WithdrawnNot Applicable

Rapid Sequence Intubation Drug Delivery Using Intraosseous and IV Access in Pediatric Patients Observational Study

Stopped: No subject enrollment.

United States0Started 2012-09

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * subjects in whom vascular access for rapid sequence intubation drug administration was established prior to arrival to the emergency department.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time from determination of need for vascular access for rapid sequence intubation to administration of first does of paralytic agent.

Timeframe: 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.

Timeframe: during rapid sequence intubation procedure, average expected time frame 30 minutes

time from vascular access to successful intubation

Timeframe: during rapid sequence intubation procedure, average expected time frame 30 minutes

number of attempts necessary for successful intubation

Timeframe: during rapid sequence intubation procedure, average expected time frame 30 minutes

Trial details

NCT IDNCT01634867

SponsorVidacare Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-08

View on ClinicalTrials.gov More Airway Control trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Time from determination of need for vascular access for rapid sequence intubation to administration of first does of paralytic agent.

Timeframe: 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.

Timeframe: during rapid sequence intubation procedure, average expected time frame 30 minutes

time from vascular access to successful intubation

Timeframe: during rapid sequence intubation procedure, average expected time frame 30 minutes

number of attempts necessary for successful intubation

Timeframe: during rapid sequence intubation procedure, average expected time frame 30 minutes