Endotracheal TubeNCT03385044
Comparison of Endotracheal Intracuff Pressure Between Two Cuff Sealing Methods
A study testing MOVT and VE/VI ratio of Spirometer in people with Endotracheal Tube, run by DongGuk University at 1 site in South Korea.
Trial summary
The endotracheal intracuff pressure is to be maintained at a low level to prevent trachea and nerve damages, and yet be high enough to secure air sealing. The objective of the study is to compare minimal occlusive volume technique (MOVT) and expired volume/inspired volume ratio (VE/VI ratio) from a spirometer method… Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Endotracheal Tube
- What is being tested?
- MOVT and VE/VI ratio of Spirometer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Mar 2018to 29 Oct 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status I, II
- Body mass index < 30 kg/m2
- Elective laparoscopic gynecologic surgery under general anesthesia in the Trendelenburg position
Who cannot join
- History of airway-related or pulmonary diseases/abnormalities
- When difficult intubation is anticipated
- History of general anesthesia within the past 3 months
- Pregnancy
- History of smoking
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital
Goyang, Gyeonggido, 10326
About this study
The endotracheal intracuff pressure is to be maintained at a low level to prevent trachea and nerve damages, and yet be high enough to secure air sealing. The objective of the study is to compare minimal occlusive volume technique (MOVT) and expired volume/inspired volume ratio (VE/VI ratio) from a spirometer method of endotracheal tube (ETT) cuff inflation with respect to the cuff pressure required to seal the airway during a laparoscopic surgery under general anesthesia. A study design is a randomized crossover trial in 35 patients. The primary outcome is the intracuff pressure of an endotracheal tube. The study consists of two cuff sealing methods separated by a period of 10 minutes.
- Conditions
- Endotracheal Tube
- Being tested
- MOVT, VE/VI ratio of Spirometer
- Keywords
- Endotracheal tube, Intracuff pressure, Minimal occlusive volume technique, Spirometer, Endotracheal sealing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOVTProcedure or surgery
ETT cuff will be inflated till the disappearance of audible air leak on auscultation, while abdominal carbon dioxide (CO2) inflation is maintained with peak inspiratory pressure of 25 cm H2O during volume controlled ventilation. The patient will be in the Trendelenburg position.
VE/VI ratio of SpirometerProcedure or surgery
ETT cuff will be inflated till the VE/VI ratio meets the initial VE/VI ratio, while abdominal CO2 inflation is maintained with peak inspiratory pressure of 25 cm H2O during volume controlled ventilation. The patient will be in the Trendelenburg position.
| Study group | Role | What they receive |
|---|---|---|
| Cuff sealing by MOVT | Active comparator | MOVT (minimal occlusive volume technique). The cuff sealing will be confirmed with MOVT, then the intracuff pressure will be measured. Receives: Procedure: MOVT |
| Cuff sealing by VE/VI ratio | Active comparator | VE/VI ratio of Spirometer. The cuff sealing will be confirmed with VE/VI ratio of a spirometer, then the intracuff pressure will be measured. Receives: Procedure: VE/VI ratio of Spirometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracuff Pressure
The intracuff pressure of endotracheal tube when cuff sealing is achieved.
Measured: From the start of cuff inflation to the airway sealing, an average of 2 minutes
Secondary outcomes (1)
Intracuff air volume
The intracuff air volume of endotracheal tube when cuff sealing is achieved.
Measured: From the start of cuff inflation to the airway sealing, an average of 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start12 Mar 2018
- Primary completion29 Oct 2018
- Study completion29 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal TubeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two methods of cuff sealing will be applied in a random sequence to each patient.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- DongGuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junyong In, MD, PhD, DongGuk University
- Investigators
- Junyong In, MD, PhD, Principal investigator, DongGuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385044
- Sponsor's protocol ID
- J_In_2017-01
- Status last verified
- Dec 2018
- First submitted
- 20 Dec 2017
- Last updated
- 14 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endotracheal Intracuff Pressure Between Two Cuff Sealing Methods
- ClinicalTrials.gov ID
- NCT03385044
- Acronym / sponsor ID
- J_In_2017-01
- Conditions
- Endotracheal Tube
- Keywords
- Endotracheal tube, Intracuff pressure, Minimal occlusive volume technique, Spirometer, Endotracheal sealing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- DongGuk UniversityUniversity, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- 29 Oct 2018 (actual)
- First posted
- 28 Dec 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.
The endotracheal intracuff pressure is to be maintained at a low level to prevent trachea and nerve damages, and yet be high enough to secure air sealing. The objective of the study is to compare minimal occlusive volume technique (MOVT) and expired volume/inspired volume ratio (VE/VI ratio) from a spirometer method of endotracheal tube (ETT) cuff inflation with respect to the cuff pressure required to seal the airway during a laparoscopic surgery under general anesthesia. A study design is a randomized crossover trial in 35 patients. The primary outcome is the intracuff pressure of an endotracheal tube. The study consists of two cuff sealing methods separated by a period of 10 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two methods of cuff sealing will be applied in a random sequence to each patient.
| Arm | Type | Receives |
|---|---|---|
| Cuff sealing by MOVT | Active comparator | Procedure: MOVTMOVT (minimal occlusive volume technique). The cuff sealing will be confirmed with MOVT, then the intracuff pressure will be measured. |
| Cuff sealing by VE/VI ratio | Active comparator | Procedure: VE/VI ratio of SpirometerVE/VI ratio of Spirometer. The cuff sealing will be confirmed with VE/VI ratio of a spirometer, then the intracuff pressure will be measured. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists physical status I, II
- Body mass index < 30 kg/m2
- Elective laparoscopic gynecologic surgery under general anesthesia in the Trendelenburg position
Key exclusion criteria (5 listed)
- History of airway-related or pulmonary diseases/abnormalities
- When difficult intubation is anticipated
- History of general anesthesia within the past 3 months
- Pregnancy
- History of smoking
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 |
|---|---|---|
| MOVTETT cuff will be inflated till the disappearance of audible air leak on auscultation, while abdominal carbon dioxide (CO2) inflation is maintained with peak inspiratory pressure of 25 cm H2O during volume controlled ventilation. The patient will be in the Trendelenburg position. | Procedure or surgery | Cuff sealing by MOVT |
| VE/VI ratio of SpirometerETT cuff will be inflated till the VE/VI ratio meets the initial VE/VI ratio, while abdominal CO2 inflation is maintained with peak inspiratory pressure of 25 cm H2O during volume controlled ventilation. The patient will be in the Trendelenburg position. | Procedure or surgery | Cuff sealing by VE/VI ratio |
Primary outcome
Intracuff Pressure
Time frame: From the start of cuff inflation to the airway sealing, an average of 2 minutes
The intracuff pressure of endotracheal tube when cuff sealing is achieved.
1 secondary outcome
Intracuff air volume
Time frame: From the start of cuff inflation to the airway sealing, an average of 2 minutes
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 14 Dec 2018.
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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.
Junyong In, MD, PhD 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 MOVT and VE/VI ratio of Spirometer in people with Endotracheal Tube, 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 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 14 Dec 2018. 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 (time frame: From the start of cuff inflation to the airway sealing, an average of 2 minutes). 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 14 Dec 2018.