CholecystitisNCT02827110
Tracheal Intubation in Patient With Semi-rigid Collar Immobilization of the Cervical Spine: A Comparison of Fiberoptic Bronchoscope Assisted With Pentax-airway Scope and Fiberoptic Bronchoscope Alone
A study testing fiberoptic bronchoscope, pentax-airway scope and semi-rigid collar in people with Cholecystitis, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
A semi-rigid cervical collar is recommended for immobilization of the cervical spine in patients with cervical spine injury. It has been suggested that a reduction in mouth opening is the major contributing factor to the deterioration in the glottic view obtained. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Cholecystitis
- What is being tested?
- fiberoptic bronchoscope, pentax-airway scope and semi-rigid collar
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2016to Dec 2016
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist physical status class I, II
Who cannot join
- uncontrolled or limited cardiovascular disease
- abnormality of airway
- necessity for rapid sequence induction
- BMI > 30
Trial locations and contacts
1 site in 1 country.
About this study
A semi-rigid cervical collar is recommended for immobilization of the cervical spine in patients with cervical spine injury. It has been suggested that a reduction in mouth opening is the major contributing factor to the deterioration in the glottic view obtained. Fiberoptic intubation is among the most versatile techniques for managing both the anticipated and the unanticipated difficult airway. Recently, combination of fiberoptic bronchoscope with videolaryngoscope has been suggested to permit visual control of the passage of the tube over the fibrescope into the laryngeal inlet. The aim of this study is to compare the intubation time and ease of intubation between fiberoptic bronchoscope alone and bronchoscope with pentax airwayscope.
- Conditions
- Cholecystitis
- Being tested
- fiberoptic bronchoscope, pentax-airway scope, semi-rigid collar
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fiberoptic bronchoscopeDevice
Tracheal intubation using fiberoptic bronchoscope
pentax-airway scopeDevice
Tracheal intubation using pentax-AWS
semi-rigid collarProcedure or surgery
semi-rigid collar immobilization of the cervical spine
| Study group | Role | What they receive |
|---|---|---|
| fiberoptic bronchoscope | Active comparator | Tracheal intubation in patients with semi-rigid collar immobilization of the cervical spine using fiberoptic bronchoscope Receives: Device: fiberoptic bronchoscope; Procedure: semi-rigid collar |
| fiberoptic bronchoscope with pentax-AWS | Experimental | Tracheal intubation in patients with semi-rigid collar immobilization of the cervical spine using fiberoptic bronchoscope with pentax-AWS Receives: Device: fiberoptic bronchoscope; Device: pentax-airway scope; Procedure: semi-rigid collar |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to intubation
Measured: Time from device passing the mouth until confirmation of tracheal intubation by bronchoscope will be measured, about 2 minutes
Secondary outcomes (1)
ease of intubation
Numeric rating scale 0-10 (0:easy without any difficulty, 10: impossible to intubate)
Measured: Numeric rating scale will be assessed by practioner of fiberoptic bronchoscope for intubation immediately after intubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2016
- Study completionDec 2016
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 CholecystitisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yun jeong chae, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827110
- Sponsor's protocol ID
- AJIRB-MED-DE2-16-060
- Status last verified
- Jun 2017
- First submitted
- 16 Jun 2016
- Last updated
- 28 Jun 2017
- Results posted
- No
Publications
Kim DH, Yoo JY, Ha SY, Chae YJ. Comparison of the paediatric blade of the Pentax-AWS and Ovassapian airway in fibreoptic tracheal intubation in patients with limited mouth opening and cervical spine immobilization by a semi-rigid neck collar: a randomized controlled trial. Br J Anaesth. 2017 Nov 1;119(5):993-999. doi: 10.1093/bja/aex272.
PubMed 28981579
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheal Intubation in Patient With Semi-rigid Collar Immobilization of the Cervical Spine: A Comparison of Fiberoptic Bronchoscope Assisted With Pentax-airway Scope and Fiberoptic Bronchoscope Alone
- ClinicalTrials.gov ID
- NCT02827110
- Acronym / sponsor ID
- AJIRB-MED-DE2-16-060
- Conditions
- Cholecystitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Jul 2016 (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.
A semi-rigid cervical collar is recommended for immobilization of the cervical spine in patients with cervical spine injury. It has been suggested that a reduction in mouth opening is the major contributing factor to the deterioration in the glottic view obtained. Fiberoptic intubation is among the most versatile techniques for managing both the anticipated and the unanticipated difficult airway. Recently, combination of fiberoptic bronchoscope with videolaryngoscope has been suggested to permit visual control of the passage of the tube over the fibrescope into the laryngeal inlet. The aim of this study is to compare the intubation time and ease of intubation between fiberoptic bronchoscope alone and bronchoscope with pentax airwayscope.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fiberoptic bronchoscope | Active comparator | Device: fiberoptic bronchoscope, Procedure: semi-rigid collarTracheal intubation in patients with semi-rigid collar immobilization of the cervical spine using fiberoptic bronchoscope |
| fiberoptic bronchoscope with pentax-AWS | Experimental | Device: fiberoptic bronchoscope, Device: pentax-airway scope, Procedure: semi-rigid collarTracheal intubation in patients with semi-rigid collar immobilization of the cervical spine using fiberoptic bronchoscope with pentax-AWS |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologist physical status class I, II
Key exclusion criteria (4 listed)
- uncontrolled or limited cardiovascular disease
- abnormality of airway
- necessity for rapid sequence induction
- BMI > 30
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 |
|---|---|---|
| fiberoptic bronchoscopeTracheal intubation using fiberoptic bronchoscope | Device | fiberoptic bronchoscope, fiberoptic bronchoscope with pentax-AWS |
| pentax-airway scopeTracheal intubation using pentax-AWS | Device | fiberoptic bronchoscope with pentax-AWS |
| semi-rigid collarsemi-rigid collar immobilization of the cervical spine | Procedure or surgery | fiberoptic bronchoscope, fiberoptic bronchoscope with pentax-AWS |
Primary outcome
time to intubation
Time frame: Time from device passing the mouth until confirmation of tracheal intubation by bronchoscope will be measured, about 2 minutes
1 secondary outcome
ease of intubation
Time frame: Numeric rating scale will be assessed by practioner of fiberoptic bronchoscope for intubation immediately after intubation.
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 28 Jun 2017.
- Derived from this study: PubMed 28981579Kim DH, Yoo JY, Ha SY, Chae YJ. Comparison of the paediatric blade of the Pentax-AWS and Ovassapian airway in fibreoptic tracheal intubation in patients with limited mouth opening and cervical spine immobilization by a semi-rigid neck collar: a randomized controlled trial. Br J Anaesth. 2017 Nov 1;119(5):993-999. doi: 10.1093/bja/aex272.
Related trials for Cholecystitis
Recruiting
Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration
Cholelithiases, Cholecystitis
Recruiting
STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy
Cholelithiasis, Cholecystitis
Not yet recruitingObservational study
SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation
Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice
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 fiberoptic bronchoscope, pentax-airway scope and semi-rigid collar in people with Cholecystitis, run by Ajou University School of Medicine at 1 site in South Korea.
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 1 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 28 Jun 2017. 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 South Korea. 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?
time to intubation (time frame: Time from device passing the mouth until confirmation of tracheal intubation by bronchoscope will be measured, about 2 minutes). 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 NCT02827110, 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 28 Jun 2017.