Adverse Effect of Other General AnestheticsNCT01812915
Comparison of Tapered- vs. Cylindrical-shaped Tube Cuffs Pressure Alteration With Nitrous Oxide
A study testing Cylindrical-shape cuff ETT (Group C) and Tapered-shape cuff ETT (Group T) in people with Adverse Effect of Other General Anesthetics and Anesthesia Intubation Complication, run by DongGuk University at 1 site in South Korea.
Trial summary
When using nitrous oxide for general anesthesia, nitrous oxide diffusion induces intracuff hyperinflation of the endotracheal tube. Furthermore the difference among various types of cuffed endotracheal tubes in cuff pressure behavior during nitrous oxide exposure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Adverse Effect of Other General Anesthetics, Anesthesia Intubation Complication, Inhalation of Nitrous Oxide
- What is being tested?
- Cylindrical-shape cuff ETT (Group C) and Tapered-shape cuff ETT (Group T)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Apr 2015
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will undergo general anesthesia in a supine position with a neutral position of the head (hand and forearm sugery)
- 18~70 years old
- American society of anesthesiologists physical status 1-2
- Body mass index < 30 kg/m2
Who cannot join
- Contraindication for nitrous oxide
- Difficult intubation
- Cormack-Lehane grade > 3
- Airway-related or pulmonary diseases
- Short or long operation time (< 1 hour or > 3 hours)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dongguk University Ilsan Hospital
Goyang, Gyeonggido, 10326
About this study
Official title: Comparison of Tapered- vs. Cylindrical-shaped Tube Cuffs Pressure Alteration With Nitrous Oxide Diffusion Under General Anesthesia
When using nitrous oxide for general anesthesia, nitrous oxide diffusion induces intracuff hyperinflation of the endotracheal tube. Furthermore the difference among various types of cuffed endotracheal tubes in cuff pressure behavior during nitrous oxide exposure.
TaperGuard(TM) tube has been newly introduced and has tapered-shape cuff. In vitro study, the intracuff pressure of TaperGuard(TM) tube was lower than that of conventional tube with cylindrical-shaped cuff of the conventional tube(Hi-Lo(TM) tube). Therefore, this clinical study is needed to evaluate the intracuff pressure during general anesthesia with nitrous oxide exposure.
Read the detailed description
During 60 minutes after routine anesthetic induction and intubation of the endotracheal tubes, intracuff pressures will be measured every 10 minutes with a manometer (VBM, Sulz, Germany).
60% nitrous oxide will be added at time 0. For 60 minutes from the beginning of general anesthesia, intracuff pressures will be measured every 10 minutes.
After 60 minutes, Intracuff pressures will be maintained around 20 cm H2O during the remaining period of the surgery.
The questionnaire for a sore throat, hoarseness, and dysphagia will be questioned at about 1, 6, and 24 hours after the surgery and the general anesthesia.
- Conditions
- Adverse Effect of Other General Anesthetics, Anesthesia Intubation Complication, Inhalation of Nitrous Oxide, Trachea
- Being tested
- Cylindrical-shape cuff ETT (Group C), Tapered-shape cuff ETT (Group T)
- Keywords
- Cuff pressure, Cylindrical cuff, Endotracheal tube, Nitrous oxide, Tapered cuff
- Medical subject headings
- Tracheal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cylindrical-shape cuff ETT (Group C)Device
Also called Mallinckrodt Hi-Lo(TM) endotracheal tube
Randomized allocation of the endotracheal cuffs for general anesthesia, mechanical ventilation will be maintained with Mallinckrodt Hi-Lo(TM) endotracheal tube.
Tapered-shape cuff ETT (Group T)Device
Also called Mallinckrodt TaperGuard(TM) endotracheal tube
Randomized allocation of the endotracheal cuffs for general anesthesia, mechanical ventilation will be maintained with Mallinckrodt TaperGuard(TM) endotracheal tube.
| Study group | Role | What they receive |
|---|---|---|
| Cylindrical-shape cuff ETT (Group C) | Experimental | Control group: Mallinckrodt HiLo(TM) endotracheal tube. Intracuff pressures of the tubes every 10 minutes, Adult patients under general anesthesia with Mallinckrodt Hi-Lo(TM) tube. Receives: Device: Cylindrical-shape cuff ETT (Group C) |
| Tapered-shape cuff ETT (Group T) | Experimental | Experimental group: Mallinckrodt TaperGuard(TM) endotracheal tube. Intracuff pressures of the tubes every 10 minutes, Adult patients under general anesthesia with Mallinckrodt TaperGuard(TM) tube. Receives: Device: Tapered-shape cuff ETT (Group T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracuff pressure of the endotracheal tube after 60 min (1 hour) with exposure to nitrous oxide
Measured: One hour after the exposure to nitrous oxide under general anesthesia
Secondary outcomes (4)
Intracuff pressure of the endotracheal tubes
Intracuff pressures will be measured with a manometer (VBM, Sulz, Germany)
Measured: 0, 10, 20, 30, 40, 50 minutes after exposure to nitrous oxide
Postoperative sore throat: incidence
Measured: About 1, 6, 24 hours after termination of anesthesia
Postoperative hoarseness: incidence
Measured: About 1, 6, 24 hours after termination of anesthesia
Postoperative dysphagia: incidence
Measured: About 1, 6, 24 hours after termination of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionApr 2015
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 Adverse Effect of Other General AnestheticsStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- DongGuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junyong In, MD, DongGuk University
- Investigators
- Junyong In, M.D., Ph.D., Principal investigator, DongGuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812915
- Sponsor's protocol ID
- J In 2013-1
- Status last verified
- Apr 2016
- First submitted
- 14 Mar 2013
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Tsuboi S, Miyashita T, Yamaguchi Y, Yamamoto Y, Sakamaki K, Goto T. The TaperGuard endotracheal tube intracuff pressure increase is less than that of the Hi-Lo tube during nitrous oxide exposure: a model trachea study. Anesth Analg. 2013 Mar;116(3):609-12. doi: 10.1213/ANE.0b013e318279b399. Epub 2013 Feb 11.
PubMed 23400983
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tapered- vs. Cylindrical-shaped Tube Cuffs Pressure Alteration With Nitrous Oxide Diffusion Under General Anesthesia
- ClinicalTrials.gov ID
- NCT01812915
- Acronym / sponsor ID
- J In 2013-1
- Conditions
- Adverse Effect of Other General Anesthetics, Anesthesia Intubation Complication, Inhalation of Nitrous Oxide, Trachea
- Keywords
- Cuff pressure, Cylindrical cuff, Endotracheal tube, Nitrous oxide, Tapered cuff
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- DongGuk UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 18 Mar 2013 (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.
When using nitrous oxide for general anesthesia, nitrous oxide diffusion induces intracuff hyperinflation of the endotracheal tube. Furthermore the difference among various types of cuffed endotracheal tubes in cuff pressure behavior during nitrous oxide exposure.
TaperGuard(TM) tube has been newly introduced and has tapered-shape cuff. In vitro study, the intracuff pressure of TaperGuard(TM) tube was lower than that of conventional tube with cylindrical-shaped cuff of the conventional tube(Hi-Lo(TM) tube). Therefore, this clinical study is needed to evaluate the intracuff pressure during general anesthesia with nitrous oxide exposure.
Detailed description
During 60 minutes after routine anesthetic induction and intubation of the endotracheal tubes, intracuff pressures will be measured every 10 minutes with a manometer (VBM, Sulz, Germany).
60% nitrous oxide will be added at time 0. For 60 minutes from the beginning of general anesthesia, intracuff pressures will be measured every 10 minutes.
After 60 minutes, Intracuff pressures will be maintained around 20 cm H2O during the remaining period of the surgery.
The questionnaire for a sore throat, hoarseness, and dysphagia will be questioned at about 1, 6, and 24 hours after the surgery and the general anesthesia.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cylindrical-shape cuff ETT (Group C) | Experimental | Device: Cylindrical-shape cuff ETT (Group C)Control group: Mallinckrodt HiLo(TM) endotracheal tube. Intracuff pressures of the tubes every 10 minutes, Adult patients under general anesthesia with Mallinckrodt Hi-Lo(TM) tube. |
| Tapered-shape cuff ETT (Group T) | Experimental | Device: Tapered-shape cuff ETT (Group T)Experimental group: Mallinckrodt TaperGuard(TM) endotracheal tube. Intracuff pressures of the tubes every 10 minutes, Adult patients under general anesthesia with Mallinckrodt TaperGuard(TM) tube. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who will undergo general anesthesia in a supine position with a neutral position of the head (hand and forearm sugery)
- 18~70 years old
- American society of anesthesiologists physical status 1-2
- Body mass index < 30 kg/m2
Key exclusion criteria (5 listed)
- Contraindication for nitrous oxide
- Difficult intubation
- Cormack-Lehane grade > 3
- Airway-related or pulmonary diseases
- Short or long operation time (< 1 hour or > 3 hours)
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 |
|---|---|---|
| Cylindrical-shape cuff ETT (Group C)Also: Mallinckrodt Hi-Lo(TM) endotracheal tubeRandomized allocation of the endotracheal cuffs for general anesthesia, mechanical ventilation will be maintained with Mallinckrodt Hi-Lo(TM) endotracheal tube. | Device | Cylindrical-shape cuff ETT (Group C) |
| Tapered-shape cuff ETT (Group T)Also: Mallinckrodt TaperGuard(TM) endotracheal tubeRandomized allocation of the endotracheal cuffs for general anesthesia, mechanical ventilation will be maintained with Mallinckrodt TaperGuard(TM) endotracheal tube. | Device | Tapered-shape cuff ETT (Group T) |
Primary outcome
Intracuff pressure of the endotracheal tube after 60 min (1 hour) with exposure to nitrous oxide
Time frame: One hour after the exposure to nitrous oxide under general anesthesia
4 secondary outcomes
Intracuff pressure of the endotracheal tubes
Time frame: 0, 10, 20, 30, 40, 50 minutes after exposure to nitrous oxide
Postoperative sore throat: incidence
Time frame: About 1, 6, 24 hours after termination of anesthesia
Postoperative hoarseness: incidence
Time frame: About 1, 6, 24 hours after termination of anesthesia
Postoperative dysphagia: incidence
Time frame: About 1, 6, 24 hours after termination of anesthesia
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 Apr 2016.
- Background: PubMed 23400983Tsuboi S, Miyashita T, Yamaguchi Y, Yamamoto Y, Sakamaki K, Goto T. The TaperGuard endotracheal tube intracuff pressure increase is less than that of the Hi-Lo tube during nitrous oxide exposure: a model trachea study. Anesth Analg. 2013 Mar;116(3):609-12. doi: 10.1213/ANE.0b013e318279b399. Epub 2013 Feb 11.
- Individual participant dataSharing planned: No
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.
Junyong In, M.D., Ph.D. principal investigator
DongGuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cylindrical-shape cuff ETT (Group C) and Tapered-shape cuff ETT (Group T) in people with Adverse Effect of Other General Anesthetics and Anesthesia Intubation Complication, run by DongGuk University 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 4 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 Apr 2016. 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?
Intracuff pressure of the endotracheal tube after 60 min (1 hour) with exposure to nitrous oxide (time frame: One hour after the exposure to nitrous oxide under general anesthesia). 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 NCT01812915, 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 7 Apr 2016.