Adult DiseaseNCT01346384
Time - Related Cuff Pressure and Volume of the Laryngeal Tube With the Use of Nitrous Oxide
An observational study of Adult Disease, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
The purpose of this study is to investigate the time-related intracuff pressure and volume change (which reflects the pharyngeal pressure) of the LT during anesthesia with N2O. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Adult Disease
- What is being tested?
- laryngeal tube (VBM Medizintechnik)
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteThailand
- Study dates
- May 2008to Dec 2009
- Phase
- Observational
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with general anesthesia
Who may be able to join
- American Society of Anesthesiologist physical status I or II
- Undergoing elective orthopedic surgery and surgery of breast under general anesthesia with an expected duration of 60 min or more
Who cannot join
- Height was < 155 or >180 cm (for the use of laryngeal tube size 4)
- Body mass index ≥35 kg/m2
- Preexisting laryngotracheal disease
- Risk of pulmonary aspiration of gastric contents.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the time-related intracuff pressure and volume change (which reflects the pharyngeal pressure) of the LT during anesthesia with N2O.
Read the detailed description
Background : The laryngeal tube airway (LT) is an extraglottic airway device with a proximal and distal conical cuff designed to secure a patient's airway during either spontaneous breathing or controlled ventilation. Application of this device with the use of N2O may be related to the ischemic change of the oropharyngeal mucosa. The objective of this study was to investigate the time-related intracuff pressure and volume change (which reflects the pharyngeal pressure) of the LT during anesthesia with N2O.
Methods : Seventy-five patients were studied with the use of LT size 4. N2O (66%) and isoflurane were used to maintain anesthesia. Initial intracuff pressure and volume were recorded for airway sealing during ventilation. Time-course changes of the intracuff pressure followed by recording every 10 min. If the intracuff pressure reached 100 cmH2O, the cuff was deflated to the initial intracuff pressure and the volume of deflated air and postoperative airway complications were recorded.
- Conditions
- Adult Disease
- Being tested
- laryngeal tube (VBM Medizintechnik)
- Keywords
- intracuff pressure, laryngeal tube, nitrous oxide
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laryngeal tube (VBM Medizintechnik)Device
Also called The laryngeal tube (VBM Medizintechnik, Sulz, Germany)
laryngeal tube number 4
| Study group | Role | What they receive |
|---|---|---|
| intracuff pressure N2O | measured intracuff pressure of LT with N2o during operative period Receives: Device: laryngeal tube (VBM Medizintechnik) |
What is being measured
The primary outcome is the main question the study is designed to answer.
intracuff pressure
measured intracuff pressure of LT with N2O during intraoperative period
Measured: 1-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startMay 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346384
- Sponsor's protocol ID
- LT-N2O
- Status last verified
- Apr 2011
- First submitted
- 25 Apr 2011
- Last updated
- 5 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time - Related Cuff Pressure and Volume of the Laryngeal Tube With the Use of Nitrous Oxide
- ClinicalTrials.gov ID
- NCT01346384
- Acronym / sponsor ID
- LT-N2O
- Conditions
- Adult Disease
- Keywords
- intracuff pressure, laryngeal tube, nitrous oxide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 3 May 2011 (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.
The purpose of this study is to investigate the time-related intracuff pressure and volume change (which reflects the pharyngeal pressure) of the LT during anesthesia with N2O.
Detailed description
Background : The laryngeal tube airway (LT) is an extraglottic airway device with a proximal and distal conical cuff designed to secure a patient's airway during either spontaneous breathing or controlled ventilation. Application of this device with the use of N2O may be related to the ischemic change of the oropharyngeal mucosa. The objective of this study was to investigate the time-related intracuff pressure and volume change (which reflects the pharyngeal pressure) of the LT during anesthesia with N2O.
Methods : Seventy-five patients were studied with the use of LT size 4. N2O (66%) and isoflurane were used to maintain anesthesia. Initial intracuff pressure and volume were recorded for airway sealing during ventilation. Time-course changes of the intracuff pressure followed by recording every 10 min. If the intracuff pressure reached 100 cmH2O, the cuff was deflated to the initial intracuff pressure and the volume of deflated air and postoperative airway complications were recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intracuff pressure N2O | – | Device: laryngeal tube (VBM Medizintechnik)measured intracuff pressure of LT with N2o during operative period |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with general anesthesia
Key inclusion criteria (2 listed)
- American Society of Anesthesiologist physical status I or II
- Undergoing elective orthopedic surgery and surgery of breast under general anesthesia with an expected duration of 60 min or more
Key exclusion criteria (4 listed)
- Height was < 155 or >180 cm (for the use of laryngeal tube size 4)
- Body mass index ≥35 kg/m2
- Preexisting laryngotracheal disease
- Risk of pulmonary aspiration of gastric contents.
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 |
|---|---|---|
| laryngeal tube (VBM Medizintechnik)Also: The laryngeal tube (VBM Medizintechnik, Sulz, Germany)laryngeal tube number 4 | Device | intracuff pressure N2O |
Primary outcome
intracuff pressure
Time frame: 1-4 hours
measured intracuff pressure of LT with N2O during intraoperative period
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 5 May 2011.
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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.
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?
An observational study of Adult Disease, run by Prince of Songkla University at 1 site in Thailand.
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 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 5 May 2011. 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 Thailand. 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 (time frame: 1-4 hours). 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 5 May 2011.