OrthosisNCT03210922
Semirigid Cervical Collar and Nasotracheal Intubation by Glidescope in Cervical Spine Surgery
A study testing Miami cervical collar in people with Orthosis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Effect of semirigid cervical collar during nasotracheal intubation by Glidescope in the elective cervical spinal surgical patients: a study of clinical predictors and outcomes Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Orthosis
- What is being tested?
- Miami cervical collar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Jul 2017to 18 Apr 2018
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective cervical spine surgery
- scheduled for nasotracheal intubation
- not requiring orthosis for prophylactic protection
Who cannot join
- Risk of pulmonary aspiration of gastric contents
- Pathology of the nasal cavity
- Abnormal coagulation function
- Extensive and severe cord compression
- Refused to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Semirigid Cervical Collar During Nasotracheal Intubation by Glidescope in the Elective Cervical Spinal Surgical Patients: a Study of Clinical Predictors and Outcomes
Effect of semirigid cervical collar during nasotracheal intubation by Glidescope in the elective cervical spinal surgical patients: a study of clinical predictors and outcomes
Read the detailed description
Clinically used cervical orthoses can effectively limit cervical spine motion in all direction and provide protection. Among them, the restriction by Miami semirigid collar was superior, with the least tissue-interface pressure of neck. It is one of the most used semirigid collars for patients' protection in the operating theatre. However, the presence of the semirigid collar was shown to result in a poorer view at laryngoscopy, possibly due to a reduction in mouth opening. Nasotracheal intubation is sometimes applied in cervical spinal surgeries for those receiving anterior approach for a higher cervical spine (C3) level, and/ or combined with a short neck, or due to surgeon's preference. Glidescope minimizes cervical movements during laryngoscopy, facilitates nasotracheal intubation than direct laryngoscopy and requires less technical skill than fiberoptic tracheal intubation. The investigation was to assess the effect of cervical collar on nasotracheal intubation and potential hazard factors of prolonged time for nasotracheal intubation with Gildescope in patients scheduled for elective cervical spinal surgery.
- Conditions
- Orthosis
- Being tested
- Miami cervical collar
- Keywords
- cervical collar, nasoendotracheal intubation, glidescope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miami cervical collarDevice
Collar group is put on the Miami cervical collar.
| Study group | Role | What they receive |
|---|---|---|
| Collar group | Experimental | Standard of anesthetic care and nasointubation with patient wearing the Miami cervical collar. Receives: Device: Miami cervical collar |
| Non-collar group | No intervention | Standard of anesthetic care and nasointubation with patient not wearing the Miami cervical collar. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasointubation Time
intubation time assisted by Glidescope
Measured: Intraoperative
Secondary outcomes (2)
subjective scoring of ease of intubation
ease of intubation scored with visual analogue scale
Measured: Intraoperative
magill forceps for nasointubation
whether magill forcepts is required to facilitate nasointubation
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start13 Jul 2017
- Primary completion13 Apr 2018
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthosisStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients are randomized into one of the two group: the collar group or the non-collar group before anesthetic induction. In the collar group, the patient was put on a Miami cervical collar and then anesthetic induction and nasotracheal intubation are performed. the non-collar group receive the same anesthetic care without a collar as a control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Wen-Cheng Huang, M.D., Ph.D., Principal investigator, Center of Neural Regeneration, Department of Neurosurgery, Neurological Institute, Taipei Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210922
- Sponsor's protocol ID
- 2017-06-009B
- Status last verified
- May 2019
- First submitted
- 19 Jun 2017
- Last updated
- 7 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Semirigid Cervical Collar During Nasotracheal Intubation by Glidescope in the Elective Cervical Spinal Surgical Patients: a Study of Clinical Predictors and Outcomes
- ClinicalTrials.gov ID
- NCT03210922
- Acronym / sponsor ID
- 2017-06-009B
- Conditions
- Orthosis
- Keywords
- cervical collar, nasoendotracheal intubation, glidescope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 7 Jul 2017 (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.
Effect of semirigid cervical collar during nasotracheal intubation by Glidescope in the elective cervical spinal surgical patients: a study of clinical predictors and outcomes
Detailed description
Clinically used cervical orthoses can effectively limit cervical spine motion in all direction and provide protection. Among them, the restriction by Miami semirigid collar was superior, with the least tissue-interface pressure of neck. It is one of the most used semirigid collars for patients' protection in the operating theatre. However, the presence of the semirigid collar was shown to result in a poorer view at laryngoscopy, possibly due to a reduction in mouth opening. Nasotracheal intubation is sometimes applied in cervical spinal surgeries for those receiving anterior approach for a higher cervical spine (C3) level, and/ or combined with a short neck, or due to surgeon's preference. Glidescope minimizes cervical movements during laryngoscopy, facilitates nasotracheal intubation than direct laryngoscopy and requires less technical skill than fiberoptic tracheal intubation. The investigation was to assess the effect of cervical collar on nasotracheal intubation and potential hazard factors of prolonged time for nasotracheal intubation with Gildescope in patients scheduled for elective cervical spinal surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The patients are randomized into one of the two group: the collar group or the non-collar group before anesthetic induction. In the collar group, the patient was put on a Miami cervical collar and then anesthetic induction and nasotracheal intubation are performed. the non-collar group receive the same anesthetic care without a collar as a control.
| Arm | Type | Receives |
|---|---|---|
| Collar group | Experimental | Device: Miami cervical collarStandard of anesthetic care and nasointubation with patient wearing the Miami cervical collar. |
| Non-collar group | No intervention | –Standard of anesthetic care and nasointubation with patient not wearing the Miami cervical collar. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective cervical spine surgery
- scheduled for nasotracheal intubation
- not requiring orthosis for prophylactic protection
Key exclusion criteria (5 listed)
- Risk of pulmonary aspiration of gastric contents
- Pathology of the nasal cavity
- Abnormal coagulation function
- Extensive and severe cord compression
- Refused to sign informed consent.
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 |
|---|---|---|
| Miami cervical collarCollar group is put on the Miami cervical collar. | Device | Collar group |
Primary outcome
Nasointubation Time
Time frame: Intraoperative
intubation time assisted by Glidescope
2 secondary outcomes
subjective scoring of ease of intubation
Time frame: Intraoperative
magill forceps for nasointubation
Time frame: Intraoperative
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 7 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
Wen-Cheng Huang, M.D., Ph.D. principal investigator
Center of Neural Regeneration, Department of Neurosurgery, Neurological Institute, Taipei Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miami cervical collar in people with Orthosis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 3 inclusion and 5 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 7 May 2019. 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 Taiwan. 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?
Nasointubation Time (time frame: Intraoperative). 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 7 May 2019.