Laryngeal Mask AirwayNCT03365557
Airway Peak Pressure-directed Laryngeal Mask Airway Intracuff Pressure Setting
A study testing Airway peak pressure in people with Laryngeal Mask Airway, run by Yangzhou University.
Trial summary
The investigators aimed to explore the effects of airway peak pressure (Ppeak) guidance on the least laryngeal mask airway (LMA) intracuff pressure setting during general anesthesia and the effects on postoperative complications in the throat. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laryngeal Mask Airway
- What is being tested?
- Airway peak pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 30 Apr 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with American Society of Anesthesiologists grades I or II scheduled for elective laparoscopic cholecystectomy under general anesthesia
Who cannot join
- Patients with limited head and neck activity, limited mouth opening, high abdominal pressure, inflammation of the throat and respiratory diseases
About this study
Official title: A Clinical Study of the Setting of Laryngeal Mask Airway Intracuff Pressure Based on Airway Peak Pressure
The investigators aimed to explore the effects of airway peak pressure (Ppeak) guidance on the least laryngeal mask airway (LMA) intracuff pressure setting during general anesthesia and the effects on postoperative complications in the throat. One hundred and twenty patients (American Society of Anesthesiologists grades I or II) scheduled for elective laparoscopic cholecystectomy under general anesthesia were enrolled in our study. The patients were divided into pressure-regulated group (group P) and control group (group C) randomly. Supreme LMA was inserted in after general anesthesia induction. Air was injected into the cuff to make the intracuff pressure (ICP) achieve 60 cmH2O. Volume-controlled ventilation was selected and Ppeak was recorded. In group P, all the gas in the LMA cuff was sucked out, and then air was injected in during expiration phase to make ICP achieve the level of Ppeak. If there's any leakage, increase 5 cmH2O every time till there's no air leakage from the mouth. After pneumoperitoneum, the cuff was inflated to make ICP achieve 60 cmH2O and Ppeak was recorded once more. Then all the gas in the LMA cuff was sucked out, and air was injected into the cuff during expiration phase to make ICP achieve the level of Ppeak as the above method till the end of operation. During pneumoperitoneum, the pressure of CO2 was set at 10 cmH2O. In group C, ICP was maintained at 60 cmH2O. Ppeak, ICP and the intracuff gas volume were recorded before and after pneumoperitoneum. ICP during inspiratory phase in the two groups was measured. Tidal volume during inspiration (VTI) and expiration (VTE) in the two groups were recorded, and the leakage rate was calculated as [(VTI-VTE)/ VTI×100%]. Throat complications of all the patients in 24 hours after surgeries were also recorded.
- Conditions
- Laryngeal Mask Airway
- Being tested
- Airway peak pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway peak pressureProcedure or surgery
Air was injected into LMA cuff during expiration phase to make intracuff pressure achieve the level of airway peak pressure. If there's any leakage, increase 5 cmH2O every time till there's no air leakage from the mouth.
| Study group | Role | What they receive |
|---|---|---|
| Intracuff pressure set by airway peak pressure | Experimental | Not described Receives: Procedure: Airway peak pressure |
| Intracuff pressure set at 60 mmHg | Other | Not described Receives: Procedure: Airway peak pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intracuff gas volume before pneumoperitoneum
The changes of intracuff gas volume before pneumoperitoneum
Measured: Intraoperative
The intracuff gas volume after pneumoperitoneum
The changes of intracuff gas volume after pneumoperitoneum
Measured: Intraoperative
The intracuff pressure before pneumoperitoneum
The changes of intracuff pressure before pneumoperitoneum
Measured: Intraoperative
The intracuff pressure after pneumoperitoneum
The changes of intracuff pressure after pneumoperitoneum
Measured: Intraoperative
Secondary outcomes (1)
Throat complications
Throat pain, swallow discomfort and hematoma
Measured: From the end of operation till 24 hs postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Oct 2016
- Primary completion31 Mar 2017
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal Mask AirwayStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Zhang, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365557
- Sponsor's protocol ID
- 20171110
- Status last verified
- Dec 2017
- First submitted
- 10 Nov 2017
- Last updated
- 18 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the Setting of Laryngeal Mask Airway Intracuff Pressure Based on Airway Peak Pressure
- ClinicalTrials.gov ID
- NCT03365557
- Acronym / sponsor ID
- 20171110
- Conditions
- Laryngeal Mask Airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Yangzhou UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 7 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 investigators aimed to explore the effects of airway peak pressure (Ppeak) guidance on the least laryngeal mask airway (LMA) intracuff pressure setting during general anesthesia and the effects on postoperative complications in the throat. One hundred and twenty patients (American Society of Anesthesiologists grades I or II) scheduled for elective laparoscopic cholecystectomy under general anesthesia were enrolled in our study. The patients were divided into pressure-regulated group (group P) and control group (group C) randomly. Supreme LMA was inserted in after general anesthesia induction. Air was injected into the cuff to make the intracuff pressure (ICP) achieve 60 cmH2O. Volume-controlled ventilation was selected and Ppeak was recorded. In group P, all the gas in the LMA cuff was sucked out, and then air was injected in during expiration phase to make ICP achieve the level of Ppeak. If there's any leakage, increase 5 cmH2O every time till there's no air leakage from the mouth. After pneumoperitoneum, the cuff was inflated to make ICP achieve 60 cmH2O and Ppeak was recorded once more. Then all the gas in the LMA cuff was sucked out, and air was injected into the cuff during expiration phase to make ICP achieve the level of Ppeak as the above method till the end of operation. During pneumoperitoneum, the pressure of CO2 was set at 10 cmH2O. In group C, ICP was maintained at 60 cmH2O. Ppeak, ICP and the intracuff gas volume were recorded before and after pneumoperitoneum. ICP during inspiratory phase in the two groups was measured. Tidal volume during inspiration (VTI) and expiration (VTE) in the two groups were recorded, and the leakage rate was calculated as [(VTI-VTE)/ VTI×100%]. Throat complications of all the patients in 24 hours after surgeries were also recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracuff pressure set by airway peak pressure | Experimental | Procedure: Airway peak pressure |
| Intracuff pressure set at 60 mmHg | Other | Procedure: Airway peak pressure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with American Society of Anesthesiologists grades I or II scheduled for elective laparoscopic cholecystectomy under general anesthesia
Key exclusion criteria (1 listed)
- Patients with limited head and neck activity, limited mouth opening, high abdominal pressure, inflammation of the throat and respiratory diseases
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 |
|---|---|---|
| Airway peak pressureAir was injected into LMA cuff during expiration phase to make intracuff pressure achieve the level of airway peak pressure. If there's any leakage, increase 5 cmH2O every time till there's no air leakage from the mouth. | Procedure or surgery | Intracuff pressure set at 60 mmHg, Intracuff pressure set by airway peak pressure |
Primary outcome
The intracuff gas volume before pneumoperitoneum
Time frame: Intraoperative
The changes of intracuff gas volume before pneumoperitoneum
The intracuff gas volume after pneumoperitoneum
Time frame: Intraoperative
The changes of intracuff gas volume after pneumoperitoneum
The intracuff pressure before pneumoperitoneum
Time frame: Intraoperative
The changes of intracuff pressure before pneumoperitoneum
The intracuff pressure after pneumoperitoneum
Time frame: Intraoperative
The changes of intracuff pressure after pneumoperitoneum
1 secondary outcome
Throat complications
Time frame: From the end of operation till 24 hs postoperative
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 Mar 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Airway peak pressure in people with Laryngeal Mask Airway, run by Yangzhou University.
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 1 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 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The intracuff gas volume before pneumoperitoneum (time frame: Intraoperative). The study lists 4 primary outcomes in all. 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 18 Mar 2020.