Intubation, IntratrachealNCT04591769
Tracheal Tube Cuff Shape and Pressure
A study testing Different tracheal tube cuff design in people with Intubation, Intratracheal and Pain, Postoperative, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
This is a randomized controlled trial focusing on the effect of different tracheal tube cuff shape; the tapered-shaped tracheal tube cuff versus the cylindrical-shaped tracheal cuff in anterior cervical spine surgery. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Intubation, Intratracheal, Pain, Postoperative, Dysphonia
- What is being tested?
- Different tracheal tube cuff design
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Nov 2020to 30 Jun 2021
- 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
- Receiving elective anterior cervical spine surgery
- Right side approach
Who cannot join
- Unstable cervical spine (acute trauma history, or dislocation/ subluxation in image studies)
- Anticipated difficult airway
- Facial anomaly that may hinder facemask ventilation
- Preoperative hoarseness or vocal cord palsy regardless of etiology
- Re-operation of cervical spine surgery or left side approach
- BMI >35
Show all 9Show fewer
- Operation field involved cervical spine C1 or C2
- Unwilling to sign the informed consent
- Unwilling to finish the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cuff Pressure During Surgical Retractor Splay and Postoperative Voice Outcome After Anterior Cervical Spine Surgery: Comparison Between Tapered-shaped and Conventional Cylindrical-shaped Endotracheal Tube
This is a randomized controlled trial focusing on the effect of different tracheal tube cuff shape; the tapered-shaped tracheal tube cuff versus the cylindrical-shaped tracheal cuff in anterior cervical spine surgery.
Read the detailed description
High endotracheal cuff pressure (ETCP) during surgical retractor splay associates with recurrent laryngeal nerve paresis/ palsy and results in post-anterior cervical spine surgery (post-ACSS) dysphonia. Control of intraoperative ETCP during ACSS may benefit voice outcome. The taper-shaped tracheal tube cuff was originally designed as a new strategy to reduce fluid leakage across the conventional cylindrical cuff and prevention of ventilator associated pneumonia. Literature has revealed the just seal pressure for the tapered-shaped tracheal tube (TT) cuff was lower than conventional cylindrical cuff. Therefore the investigators hypothesize that use of a tapered-shaped ET cuff during the surgery can lead to a lower ETCP during retractors splay and improve voice recovery after ACSS. In this study, 80 patients were randomized into 2 groups, to receive endotracheal intubation using TaperGuard tracheal tube (tapered- shaped cuff) or a conventional tracheal tube (a cylindrical cuff). The just seal pressure, intraoperative cuff pressure, and postoperative sore throat and voice outcome are recorded and compared.
- Conditions
- Intubation, Intratracheal, Pain, Postoperative, Dysphonia
- Being tested
- Different tracheal tube cuff design
- Medical subject headings
- Pain, Postoperative, Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different tracheal tube cuff designDevice
Comparison of effect between 2 different designs of tracheal tube cuff
| Study group | Role | What they receive |
|---|---|---|
| Group T(Tapered- shaped) | Experimental | Tracheal intubation using TaperedGuard Tracheal Tube Receives: Device: Different tracheal tube cuff design |
| Group C(Cylindrical-shaped) | Active comparator | Tracheal intubation using Hi-Contour Tracheal Tube Receives: Device: Different tracheal tube cuff design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Just seal tracheal tube cuff pressure
Minimal tracheal tube cuff pressure that prevent leakage of the ventilator system
Measured: 1 minute after anesthesia and tracheal intubation
Tracheal tube cuff pressure on retractor splay
Cuff pressure when the retractors are set-up and removed
Measured: Intraoperative monitoring
Secondary outcomes (7)
Sore throat-NRS
Postoperative sore throat, Numeric Rating Scale(NRS) 0~10; 0=no sore throat; 10=maximal sore throat
Measured: preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7
Sore throat-VAS
Postoperative sore throat, Visual Analogue Scale (VAS) 0~10; 0=no sore throat; 10=maximal sore throat
Measured: preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7
Subjective dysphonia
Hoarseness; Pitch; Loudness (0= none; 1= mild; 2= severe); compared with baseline
Measured: preOP day 1, post OP 2 hours, day 1, 2, 3, 7
Subjective dysphonia-GRBAS score
GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) score (normal, slight, moderate, severe); compared with baseline
Measured: One day before operation, and post operation day 1
Subjective dysphonia- Voice Handicap Index-10(VHI-10)
VHI-10 questionnaire (0 best~40 worst; >15 may be abnormal)
Measured: One day before operation, and post operation day 7
Objective dysphonia
Software voice analysis; compared with baseline
Measured: One day before operation(baseline), and post operation day 1
Postoperative complication
Any postoperative complication related complication
Measured: After operation to post operation day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start5 Nov 2020
- Primary completion31 Mar 2021
- Study completion30 Jun 2021
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 Intubation, IntratrachealStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 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
- Ya-Chun Chu, MD, PhD, Study chair, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591769
- Sponsor's protocol ID
- 2020-10-002C
- Status last verified
- Sep 2021
- First submitted
- 10 Oct 2020
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Li YS, Tan EC, Tsai YJ, Mandell MS, Huang SS, Chiang TY, Huang WC, Chang WK, Chu YC. A Tapered Cuff Tracheal Tube Decreases the Need for Cuff Pressure Adjustment After Surgical Retraction During Anterior Cervical Spine Surgery: A Randomized Controlled, Double-Blind Trial. Front Med (Lausanne). 2022 Jun 29;9:920726. doi: 10.3389/fmed.2022.920726. eCollection 2022.
PubMed 35847807
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cuff Pressure During Surgical Retractor Splay and Postoperative Voice Outcome After Anterior Cervical Spine Surgery: Comparison Between Tapered-shaped and Conventional Cylindrical-shaped Endotracheal Tube
- ClinicalTrials.gov ID
- NCT04591769
- Acronym / sponsor ID
- 2020-10-002C
- Conditions
- Intubation, Intratracheal, Pain, Postoperative, Dysphonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 19 Oct 2020 (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.
This is a randomized controlled trial focusing on the effect of different tracheal tube cuff shape; the tapered-shaped tracheal tube cuff versus the cylindrical-shaped tracheal cuff in anterior cervical spine surgery.
Detailed description
High endotracheal cuff pressure (ETCP) during surgical retractor splay associates with recurrent laryngeal nerve paresis/ palsy and results in post-anterior cervical spine surgery (post-ACSS) dysphonia. Control of intraoperative ETCP during ACSS may benefit voice outcome. The taper-shaped tracheal tube cuff was originally designed as a new strategy to reduce fluid leakage across the conventional cylindrical cuff and prevention of ventilator associated pneumonia. Literature has revealed the just seal pressure for the tapered-shaped tracheal tube (TT) cuff was lower than conventional cylindrical cuff. Therefore the investigators hypothesize that use of a tapered-shaped ET cuff during the surgery can lead to a lower ETCP during retractors splay and improve voice recovery after ACSS. In this study, 80 patients were randomized into 2 groups, to receive endotracheal intubation using TaperGuard tracheal tube (tapered- shaped cuff) or a conventional tracheal tube (a cylindrical cuff). The just seal pressure, intraoperative cuff pressure, and postoperative sore throat and voice outcome are recorded and compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group T(Tapered- shaped) | Experimental | Device: Different tracheal tube cuff designTracheal intubation using TaperedGuard Tracheal Tube |
| Group C(Cylindrical-shaped) | Active comparator | Device: Different tracheal tube cuff designTracheal intubation using Hi-Contour Tracheal Tube |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Receiving elective anterior cervical spine surgery
- Right side approach
Key exclusion criteria (9 listed)
- Unstable cervical spine (acute trauma history, or dislocation/ subluxation in image studies)
- Anticipated difficult airway
- Facial anomaly that may hinder facemask ventilation
- Preoperative hoarseness or vocal cord palsy regardless of etiology
- Re-operation of cervical spine surgery or left side approach
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 |
|---|---|---|
| Different tracheal tube cuff designComparison of effect between 2 different designs of tracheal tube cuff | Device | Group C(Cylindrical-shaped), Group T(Tapered- shaped) |
Primary outcome
Just seal tracheal tube cuff pressure
Time frame: 1 minute after anesthesia and tracheal intubation
Minimal tracheal tube cuff pressure that prevent leakage of the ventilator system
Tracheal tube cuff pressure on retractor splay
Time frame: Intraoperative monitoring
Cuff pressure when the retractors are set-up and removed
7 secondary outcomes
Sore throat-NRS
Time frame: preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7
Sore throat-VAS
Time frame: preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7
Subjective dysphonia
Time frame: preOP day 1, post OP 2 hours, day 1, 2, 3, 7
Subjective dysphonia-GRBAS score
Time frame: One day before operation, and post operation day 1
Subjective dysphonia- Voice Handicap Index-10(VHI-10)
Time frame: One day before operation, and post operation day 7
Objective dysphonia
Time frame: One day before operation(baseline), and post operation day 1
Postoperative complication
Time frame: After operation to post operation day 7
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 17 Sep 2021.
- Derived from this study: PubMed 35847807Li YS, Tan EC, Tsai YJ, Mandell MS, Huang SS, Chiang TY, Huang WC, Chang WK, Chu YC. A Tapered Cuff Tracheal Tube Decreases the Need for Cuff Pressure Adjustment After Surgical Retraction During Anterior Cervical Spine Surgery: A Randomized Controlled, Double-Blind Trial. Front Med (Lausanne). 2022 Jun 29;9:920726. doi: 10.3389/fmed.2022.920726. eCollection 2022.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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.
Ya-Chun Chu, MD, PhD study chair
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different tracheal tube cuff design in people with Intubation, Intratracheal and Pain, Postoperative, 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 2 inclusion and 9 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 17 Sep 2021. 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?
Just seal tracheal tube cuff pressure (time frame: 1 minute after anesthesia and tracheal intubation). 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 NCT04591769, 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 17 Sep 2021.