Pressure InjuryNCT03240042
Initial Increase in Cuff Pressure in Anterior Cervical Spinal Surgery
A study testing nasotracheal intubation and orotracheal intubation in people with Pressure Injury and Dysphonia, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
When the retractor blades oped and is positioned to provide the surgical access in the anterior cervical spine surgery, it cause the trachea to deviate laterally and pose pressure on the tissue between the retractor and the trachea. This is convincible as revealed by the increase of cuff pressure of endotracheal tube. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pressure Injury, Dysphonia, Dysphagia
- What is being tested?
- nasotracheal intubation and orotracheal intubation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Oct 2017to 16 Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 20-80 Scheduled cervical spine surgery, anterior approach
Who cannot join
- Severe spinal stenosis and requiring fiberoptic intubation
- Unstable spine and require orthosis
- Hisotory of difficult intubation
- History of cervical spine or neck surgery
- Coagulopathy
- Nasal pathology
Show all 10Show fewer
- Lack of informed consent
- History of previous cervical spine or neck surgery
- Anterior cervical spine surgeries after trauma, tumour resection, or spinal infection
- Preoperative dysphonia or dysphagia, regardless of the aetiology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Initial Increase in Cuff Pressure After Neck Retraction for Anterior Spine Surgery: Comparison Between Orotracheal and Nasotracheal Intubation
When the retractor blades oped and is positioned to provide the surgical access in the anterior cervical spine surgery, it cause the trachea to deviate laterally and pose pressure on the tissue between the retractor and the trachea. This is convincible as revealed by the increase of cuff pressure of endotracheal tube. The study aims to investigate differences in the increase of cuff pressure after retractor is positioned between nasotracheal and orotracheal intubation.
Read the detailed description
When the retractor blades oped and is positioned to provide the surgical access in the anterior cervical spine surgery, it cause the trachea to deviate laterally and pose pressure on the tissue between the retractor and the trachea. The most important structure is the recurrent laryngeal nerve. This is convincible as revealed by the increase of cuff pressure of endotracheal tube. The pressure created by the retractor may be related to postoperative dysphonia and dysphagia. In view of minimizing the pressure created by the retractors, some neurosurgeons advocate to deflate then to inflate the cuff of ETT tube after the retractor is on, while some advocate monitoring of cuff pressure and keep below 25 mmHg. Nasotracheal or orotracheal tube can both be applied to general anesthesia for the anterior cervical spine surgery. The option depends on the surgeons' preference. Though both approaches end at the trachea, the nasotracheal tube is fixed at the nostril, and orotracheal tube, at the mouth angle, on the opposite side of surgical approach. The investigators hypothetize this difference in location results in different degree of deviation and increase of cuff pressure. The study aims to investigate differences in the increase of cuff pressure after retractor is positioned between nasoendotracheal and oroendotracheal intubation.
Apfelbaum and colleagues indicated the asymmetric position of the oroETT within the larynx as being fixed distally by the cuff and proximally by taping at the mouth angle. The asymmetry of the tube shaft and cuff may contribute to unilateral vocal palsy. When the retractors are set up for ACCS, the deviation of cuff towards the retractors increases ETCP and creates a extrusion compression of tissues in between the cuff and the retractor blade. Nasotracheal intubation follows a more natural trajectory into the trachea. In theory, a nasoETT is more centrally located and less asymmetric in the thyroid cartilage and trachea; thus pressure from this tube may be relatively evenly distributed, and the pressure on the surrounding tissues is lower. Therefore, we hypothesised lower degree of tissue compression with a nasoETT, even during retractor splay. The effect may be reflected in intraoperative ETCP or post-ACCS dysphonia. This randomised controlled clinical trial assessed the differences in the tracheal intubation mode on the maximal ETCP during retractor splay (primary endpoint) and post-ACSS dysphonia (secondary endpoint).
- Conditions
- Pressure Injury, Dysphonia, Dysphagia
- Being tested
- nasotracheal intubation, orotracheal intubation
- Keywords
- anterior cervical spine surgery, endotracheal cuff pressure, endotracheal tracheal intubation, dysphonia
- Medical subject headings
- Pressure Ulcer, Dysphonia, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasotracheal intubationProcedure or surgery
The participants either receive intubation via nasal route.
orotracheal intubationProcedure or surgery
The participants either receive intubation via oral route.
| Study group | Role | What they receive |
|---|---|---|
| Nasoendo group | Experimental | Participants received nasotracheal intubation under general anesthesia for the anterior cervical spine surgery. Receives: Procedure: nasotracheal intubation |
| Oroendo group | Other | Participants received orotracheal intubation under general anesthesia for the anterior cervical spine surgery. Receives: Procedure: orotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
cuff pressure
cuff pressure of endotracheal tube
Measured: from time of randomization until postoperative 30 days
Secondary outcomes (3)
sore throat
postoperative sore throat by numerical rating scale (NRS), ranging from 0-10cm, 0 denoting minimal sore throat, 10 denoting maximal sore throat. score of 0 represents better outcome than score of 10.
Measured: from time of randomization until postoperative 30 days
dysphonia
postoperative dysphonia by dysphonia scoring system. subjecte grading of voice change with none, mild and obvious, in terms of hoarseness,pitch and loudness.
Measured: from time of randomization until postoperative 30 days
dysphagia
postoperative dysphonia by BAZAZ dysphagia scoring system. Severity of dsyphagia is classified as none, mild, moderate and severe. None indicates no swallowing difficulty for liquid and solid food. Mild indicated no difficulty for liquid, and rare diffilulty for solid food. Moderate indicates none or rare difficulty for liquid, occasional difficulty for solid. Severe indicates presence of difficulty for liquid and frequent difficulty for solid food.
Measured: rom time of randomization until postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start17 Oct 2017
- Primary completion15 May 2018
- Study completion16 Jun 2018
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 Pressure InjuryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly allocated into one of the two group: nasoendotracheal and oroendotracheal group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 118 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, Department of Neurosurgery, Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240042
- Sponsor's protocol ID
- 2017-07-013C
- Status last verified
- Apr 2019
- First submitted
- 2 Aug 2017
- Last updated
- 18 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huang WC, Tan EC, Huang SS, Chou CJ, Chang WK, Chu YC. Postoperative Sore Throat Helps Predict Swallowing Disturbance on Postoperative Day 30 of Anterior Cervical Spine Surgery: A Secondary Exploratory Analysis of a Randomized Clinical Trial of Tracheal Intubation Modes. Dysphagia. 2022 Feb;37(1):37-47. doi: 10.1007/s00455-021-10247-x. Epub 2021 Feb 23.
PubMed 33620562
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Increase in Cuff Pressure After Neck Retraction for Anterior Spine Surgery: Comparison Between Orotracheal and Nasotracheal Intubation
- ClinicalTrials.gov ID
- NCT03240042
- Acronym / sponsor ID
- 2017-07-013C
- Conditions
- Pressure Injury, Dysphonia, Dysphagia
- Keywords
- anterior cervical spine surgery, endotracheal cuff pressure, endotracheal tracheal intubation, dysphonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 16 Jun 2018 (actual)
- First posted
- 4 Aug 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.
When the retractor blades oped and is positioned to provide the surgical access in the anterior cervical spine surgery, it cause the trachea to deviate laterally and pose pressure on the tissue between the retractor and the trachea. This is convincible as revealed by the increase of cuff pressure of endotracheal tube. The study aims to investigate differences in the increase of cuff pressure after retractor is positioned between nasotracheal and orotracheal intubation.
Detailed description
When the retractor blades oped and is positioned to provide the surgical access in the anterior cervical spine surgery, it cause the trachea to deviate laterally and pose pressure on the tissue between the retractor and the trachea. The most important structure is the recurrent laryngeal nerve. This is convincible as revealed by the increase of cuff pressure of endotracheal tube. The pressure created by the retractor may be related to postoperative dysphonia and dysphagia. In view of minimizing the pressure created by the retractors, some neurosurgeons advocate to deflate then to inflate the cuff of ETT tube after the retractor is on, while some advocate monitoring of cuff pressure and keep below 25 mmHg. Nasotracheal or orotracheal tube can both be applied to general anesthesia for the anterior cervical spine surgery. The option depends on the surgeons' preference. Though both approaches end at the trachea, the nasotracheal tube is fixed at the nostril, and orotracheal tube, at the mouth angle, on the opposite side of surgical approach. The investigators hypothetize this difference in location results in different degree of deviation and increase of cuff pressure. The study aims to investigate differences in the increase of cuff pressure after retractor is positioned between nasoendotracheal and oroendotracheal intubation.
Apfelbaum and colleagues indicated the asymmetric position of the oroETT within the larynx as being fixed distally by the cuff and proximally by taping at the mouth angle. The asymmetry of the tube shaft and cuff may contribute to unilateral vocal palsy. When the retractors are set up for ACCS, the deviation of cuff towards the retractors increases ETCP and creates a extrusion compression of tissues in between the cuff and the retractor blade. Nasotracheal intubation follows a more natural trajectory into the trachea. In theory, a nasoETT is more centrally located and less asymmetric in the thyroid cartilage and trachea; thus pressure from this tube may be relatively evenly distributed, and the pressure on the surrounding tissues is lower. Therefore, we hypothesised lower degree of tissue compression with a nasoETT, even during retractor splay. The effect may be reflected in intraoperative ETCP or post-ACCS dysphonia. This randomised controlled clinical trial assessed the differences in the tracheal intubation mode on the maximal ETCP during retractor splay (primary endpoint) and post-ACSS dysphonia (secondary endpoint).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly allocated into one of the two group: nasoendotracheal and oroendotracheal group
| Arm | Type | Receives |
|---|---|---|
| Nasoendo group | Experimental | Procedure: nasotracheal intubationParticipants received nasotracheal intubation under general anesthesia for the anterior cervical spine surgery. |
| Oroendo group | Other | Procedure: orotracheal intubationParticipants received orotracheal intubation under general anesthesia for the anterior cervical spine surgery. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 20-80 Scheduled cervical spine surgery, anterior approach
Key exclusion criteria (10 listed)
- Severe spinal stenosis and requiring fiberoptic intubation
- Unstable spine and require orthosis
- Hisotory of difficult intubation
- History of cervical spine or neck surgery
- Coagulopathy
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 |
|---|---|---|
| nasotracheal intubationThe participants either receive intubation via nasal route. | Procedure or surgery | Nasoendo group |
| orotracheal intubationThe participants either receive intubation via oral route. | Procedure or surgery | Oroendo group |
Primary outcome
cuff pressure
Time frame: from time of randomization until postoperative 30 days
cuff pressure of endotracheal tube
3 secondary outcomes
sore throat
Time frame: from time of randomization until postoperative 30 days
dysphonia
Time frame: from time of randomization until postoperative 30 days
dysphagia
Time frame: rom time of randomization until postoperative 30 days
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 18 Apr 2019.
- Derived from this study: PubMed 33620562Huang WC, Tan EC, Huang SS, Chou CJ, Chang WK, Chu YC. Postoperative Sore Throat Helps Predict Swallowing Disturbance on Postoperative Day 30 of Anterior Cervical Spine Surgery: A Secondary Exploratory Analysis of a Randomized Clinical Trial of Tracheal Intubation Modes. Dysphagia. 2022 Feb;37(1):37-47. doi: 10.1007/s00455-021-10247-x. Epub 2021 Feb 23.
- 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
Department of Neurosurgery, Neurological Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasotracheal intubation and orotracheal intubation in people with Pressure Injury and Dysphonia, 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 1 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: finished, as of the sponsor's last update on 18 Apr 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?
cuff pressure (time frame: from time of randomization until postoperative 30 days). 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 NCT03240042, 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 18 Apr 2019; AzTrials last refreshed its copy on 27 Oct 2026.