Intubation,EndotrachealNCT00912990
Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet
A study testing Cisatracurium and Normal saline in people with Intubation,Endotracheal, run by Rady Children's Hospital, San Diego at 1 site in United States.
Trial summary
The investigators' primary specific aims are to demonstrate that: 1. Pediatric patients with normal airways, undergoing elective surgical procedures, can be successfully intubated when deeply sedated, without the use of muscle relaxants using the Shikani Optical Stylet. 2. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Intubation,Endotracheal
- What is being tested?
- Cisatracurium and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Feb 2008
- Phase
- Interventional
- 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 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6 months of age to 17 years of age (not yet 18)
- Male or female
- English or Spanish speaking
- Normal airway (Mallampati Classification )
- American Society of Anesthesiology Physical Status Classification I or II
- Elective surgical procedure expected to last at least 45 minutes in length
- Written informed consent/assent for participation given by the parent legal guardian and subject (if applicable)
Who cannot join
- < 6 months of age, > 17 years of age
- Difficult airway (Mallampati Classification)
- History of previous difficult intubation, suspected abnormal airway: *micrognathia
- facial trauma
- airway tumor
- epiglottitis
Show all 10Show fewer
- retropharyngeal abscess
- foreign body, etc.
- Scheduled for non-elective, emergent OR procedure
- Parent, legal guardian, or subject is unavailable or unwilling to consent for study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Rady Children's Hospital
San Diego, California, 92123
About this study
The investigators' primary specific aims are to demonstrate that:
- Pediatric patients with normal airways, undergoing elective surgical procedures, can be successfully intubated when deeply sedated, without the use of muscle relaxants using the Shikani Optical Stylet.
- Shikani intubation of pediatric patients is equally effective in children that are deeply sedated or paralyzed as evidenced by a non-significant difference in:
- Time to intubation (defined as no more than a 30 second time difference between the two groups);
- Incidence of adverse events.
- Conditions
- Intubation,Endotracheal
- Being tested
- Cisatracurium, Normal saline
- Keywords
- Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisatracuriumDrug
Also called Nimbex
One intravenous dose: 0.2mg/kg/dose
Normal salineDrug
One Intravenous dose
| Study group | Role | What they receive |
|---|---|---|
| Normal saline | Placebo comparator | Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg Receives: Drug: Normal saline |
| Cisatracurium | Active comparator | Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation. Receives: Drug: Cisatracurium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Intubation
Time to intubation was defined as the time (seconds) required to verify three breaths on an end-tidal carbon dioxide monitor.
Measured: Confirmed by the visualization of three carbon dioxide waveforms.
Secondary outcomes (1)
The Number of Adverse Events
The number of occurrences of each event. One subject may have multiple adverse events.
Measured: Recorded from the start of the intubation procedure to the time of successful endotracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startJan 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Why it stopped: Adequate subjects numbers not enrolled in study timeframe.
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.
- Other trials for Intubation,EndotrachealStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rady Children's Hospital, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandeep Khanna, Rady Children's Hospital, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912990
- Sponsor's protocol ID
- 11672
- Other IDs
- 06104C
- Status last verified
- Aug 2020
- First submitted
- 1 Jun 2009
- Last updated
- 18 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet
- ClinicalTrials.gov ID
- NCT00912990
- Acronym / sponsor ID
- 11672
- Conditions
- Intubation,Endotracheal
- Keywords
- Pediatric
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adequate subjects numbers not enrolled in study timeframe.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Rady Children's Hospital, San DiegoUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Posted 12 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators' primary specific aims are to demonstrate that:
- Pediatric patients with normal airways, undergoing elective surgical procedures, can be successfully intubated when deeply sedated, without the use of muscle relaxants using the Shikani Optical Stylet.
- Shikani intubation of pediatric patients is equally effective in children that are deeply sedated or paralyzed as evidenced by a non-significant difference in:
- Time to intubation (defined as no more than a 30 second time difference between the two groups);
- Incidence of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal saline | Placebo comparator | Drug: Normal salineNormal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg |
| Cisatracurium | Active comparator | Drug: CisatracuriumSubjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation. |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 6 months of age to 17 years of age (not yet 18)
- Male or female
- English or Spanish speaking
- Normal airway (Mallampati Classification )
- American Society of Anesthesiology Physical Status Classification I or II
Key exclusion criteria (10 listed)
- < 6 months of age, > 17 years of age
- Difficult airway (Mallampati Classification)
- History of previous difficult intubation, suspected abnormal airway: *micrognathia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CisatracuriumAlso: NimbexOne intravenous dose: 0.2mg/kg/dose | Drug | Cisatracurium |
| Normal salineOne Intravenous dose | Drug | Normal saline |
Primary outcome
Time to Intubation
Time frame: Confirmed by the visualization of three carbon dioxide waveforms.
Time to intubation was defined as the time (seconds) required to verify three breaths on an end-tidal carbon dioxide monitor.
1 secondary outcome
The Number of Adverse Events
Time frame: Recorded from the start of the intubation procedure to the time of successful endotracheal intubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Intubation,Endotracheal
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cisatracurium and Normal saline in people with Intubation,Endotracheal, run by Rady Children's Hospital, San Diego 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 7 inclusion and 10 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 18 Aug 2020. 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. Some participants in this study may receive a placebo. 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 12 Aug 2020). 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 to Intubation (time frame: Confirmed by the visualization of three carbon dioxide waveforms.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2020.