Airway Complication of AnesthesiaFASTERNCT05899868
Utilization of Airway Stabilizing Rod
A study testing Time to Intubation using FASTER device in people with Airway Complication of Anesthesia, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The pediatric airway is known to be more challenging than the adult airway when performing endotracheal intubation. When a patient cannot be ventilated and/or intubated, the guidelines for airway management dictate that a laryngeal mask airway (LMA) be used as a rescue device to oxygenate and ventilate the patient. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Airway Complication of Anesthesia
- What is being tested?
- Time to Intubation using FASTER device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2023to 17 May 2024
- Phase
- Interventional
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 5-18 years
- Requiring intubation
- Known difficult airway
- LMA placement possible
Who cannot join
- Known normal airway
- Procedure not requiring endotracheal intubation
- Parental refusal
- Patient dissent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utilization of Airway Stabilizing Rod to Assist With LMA Guided Fiberoptic Intubation in Children
The pediatric airway is known to be more challenging than the adult airway when performing endotracheal intubation. When a patient cannot be ventilated and/or intubated, the guidelines for airway management dictate that a laryngeal mask airway (LMA) be used as a rescue device to oxygenate and ventilate the patient. While an excellent device the LMA is seen as temporary and ultimately needs to be replaced by an endotracheal tube (ETT).
Read the detailed description
The objective is to study this device in patients with difficult airway to assess the success rate and time to intubation for placing an endotracheal tube using this device.
- Conditions
- Airway Complication of Anesthesia
- Being tested
- Time to Intubation using FASTER device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time to Intubation using FASTER deviceDevice
Also called FASTER
Time from fiberoptic placement onto airway to documentation of end-tidal carbon dioxide waveform through the endotracheal tube.
| Study group | Role | What they receive |
|---|---|---|
| Time to intubation using FASTER device | Other | Time from fiberoptic placement into airway to documentation of end-tidal carbon dioxide waveform through the endotracheal tube. Receives: Device: Time to Intubation using FASTER device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall time in the airway
Time from fiberoptic placement onto airway to documentation of end-tidal carbon dioxide waveform through the endotracheal tube.
Measured: 5 minutes
Total time to intubation
Time from movement of the device to documentation of end-tidal carbon dioxide waveform through the endotracheal tube.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start12 Oct 2023
- Primary completion17 May 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway Complication of AnesthesiaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Testing of device for success during endotracheal intubation
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arvind Chandrakantan, Baylor College of Medicine
- Investigators
- Arvind Chandrakantan, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899868
- Sponsor's protocol ID
- H50120
- Acronym
- FASTER
- Status last verified
- Dec 2024
- First submitted
- 16 May 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This pilot data will not be shared
Publications
Adler AC, Duong K, Chandrakantan A. Fiberoptic-Assisted Endotracheal Rod for Endotracheal Intubation Through a Supraglottic Airway in Patients with Difficult Intubation: A Clinical Device Study. Anesth Analg. 2025 Apr 1;140(4):986-989. doi: 10.1213/ANE.0000000000007268. Epub 2024 Nov 21. No abstract available.
PubMed 39774053
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Airway Stabilizing Rod to Assist With LMA Guided Fiberoptic Intubation in Children
- ClinicalTrials.gov ID
- NCT05899868
- Acronym / sponsor ID
- FASTER / H50120
- Conditions
- Airway Complication of Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 12 Jun 2023 (actual)
- 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.
The pediatric airway is known to be more challenging than the adult airway when performing endotracheal intubation. When a patient cannot be ventilated and/or intubated, the guidelines for airway management dictate that a laryngeal mask airway (LMA) be used as a rescue device to oxygenate and ventilate the patient. While an excellent device the LMA is seen as temporary and ultimately needs to be replaced by an endotracheal tube (ETT).
Detailed description
The objective is to study this device in patients with difficult airway to assess the success rate and time to intubation for placing an endotracheal tube using this device.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Testing of device for success during endotracheal intubation
| Arm | Type | Receives |
|---|---|---|
| Time to intubation using FASTER device | Other | Device: Time to Intubation using FASTER deviceTime from fiberoptic placement into airway to documentation of end-tidal carbon dioxide waveform through the endotracheal tube. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Ages 5-18 years
- Requiring intubation
- Known difficult airway
- LMA placement possible
Key exclusion criteria (4 listed)
- Known normal airway
- Procedure not requiring endotracheal intubation
- Parental refusal
- Patient dissent
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 |
|---|---|---|
| Time to Intubation using FASTER deviceAlso: FASTERTime from fiberoptic placement onto airway to documentation of end-tidal carbon dioxide waveform through the endotracheal tube. | Device | Time to intubation using FASTER device |
Primary outcome
Overall time in the airway
Time frame: 5 minutes
Time from fiberoptic placement onto airway to documentation of end-tidal carbon dioxide waveform through the endotracheal tube.
Total time to intubation
Time frame: 3 minutes
Time from movement of the device to documentation of end-tidal carbon dioxide waveform through the endotracheal tube.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 39774053Adler AC, Duong K, Chandrakantan A. Fiberoptic-Assisted Endotracheal Rod for Endotracheal Intubation Through a Supraglottic Airway in Patients with Difficult Intubation: A Clinical Device Study. Anesth Analg. 2025 Apr 1;140(4):986-989. doi: 10.1213/ANE.0000000000007268. Epub 2024 Nov 21. No abstract available.
- Individual participant dataSharing planned: No. This pilot data will not be shared
Related trials for Airway Complication of Anesthesia
Not yet recruitingPhase 3
Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy
Emergence Agitation, Emergence Delirium
Not yet recruiting
Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
RecruitingObservational study
Comparison of Acute Airway/Respiratory Complications and Intervention Requirements in Extubations Performed During On-Hours Versus Off-Hours
Extubation Failures, Extubation
Not yet recruitingObservational study
Effect of Night Shift Versus Daytime Duty on Tracheal Intubation Complications and Duration in Surgical Patients
Airway Management, Tracheal Intubation
Recruiting
Effect of Endotracheal Tube Cuff Pressure Management on Postoperative Sore Throat in Pediatric Laparoscopic Appendectomy
Appendicitis Acute, Postoperative Sore Throat, Cough, Hoarseness
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.
Arvind Chandrakantan, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time to Intubation using FASTER device in people with Airway Complication of Anesthesia, run by Baylor College of Medicine 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 5 Dec 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall time in the airway (time frame: 5 minutes). The study lists 2 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 NCT05899868, which also lists 1 linked publication.
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 5 Dec 2024.