Anesthesia Intubation ComplicationNCT04268043
Comparation of Proseal Laryngeal Mask Airway With Flexible Laryngeal Airway Mask
A study testing flexible laryngeal airway mask and proseal laryngeal mask airway in people with Anesthesia Intubation Complication, run by Eye & ENT Hospital of Fudan University.
Trial summary
Objective To investigate the comparative effect of proseal laryngeal mask airway and flexible laryngeal airway mask during otitis media surgery. Methods 200 patients of ASA I or II classification, 18-65 years old, BMI<30 kg/m2 undergoing otitis media surgery are randomly divided into two groups (Group P with proseal… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia Intubation Complication
- What is being tested?
- flexible laryngeal airway mask and proseal laryngeal mask airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 1 Dec 2023
- 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
- Clinical diagnosis of otitis media.
Who cannot join
- Problems with the upper airway. Gastric carcinoma. Reflux esophagitis.
About this study
Official title: Comparation of Efficacy and Safety of Proseal Laryngeal Mask Airway With Flexible Laryngeal Airway Mask in Otitis Media Surgery
Objective To investigate the comparative effect of proseal laryngeal mask airway and flexible laryngeal airway mask during otitis media surgery. Methods 200 patients of ASA I or II classification, 18-65 years old, BMI<30 kg/m2 undergoing otitis media surgery are randomly divided into two groups (Group P with proseal laryngeal mask airway and Group F with flexible laryngeal airway mask, respectively). After induction, selecting a appropriate size of LMA to patient,s weight, using the standard index finger-guided technique inserting the LMA, and then the patients were ventilated mechanically. The success rate of inserting laryngeal mask, the intubation time, surgery time and wake time were also recorded. Tidal volume and leakage pressure in patients with supine and lateral positioning were assessed respectively. The scale of fiberoptic bronchoscopy was also recorded to show airway exposure. Related complications such as sore throat, hoarseness, cough, laryngospasm, bloating, nausea and vomiting, soft tissue injury, blood residue after pulling out the LMA were analyzed.Postoperative voice and laryngopharyngeal symptom are also recorded.
- Conditions
- Anesthesia Intubation Complication
- Being tested
- flexible laryngeal airway mask, proseal laryngeal mask airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flexible laryngeal airway maskDevice
Ventilation with flexible laryngeal mask airway
proseal laryngeal mask airwayDevice
Ventilation with proseal laryngeal mask airway
| Study group | Role | What they receive |
|---|---|---|
| flexible laryngeal airway | Experimental | Not described Receives: Device: flexible laryngeal airway mask |
| proseal laryngeal mask airway | Experimental | Not described Receives: Device: proseal laryngeal mask airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful insert rate
success rate of inserting laryngeal mask
Measured: 0 minute after insertion
tidal volume
tidal volume at 15cmH2O in patients with supine and lateral positioning
Measured: 5 minute afer successful insertion
leakage pressure
leakage pressure in patients with supine and lateral positioning
Measured: 5 minute afer successful insertion
The scale of fiberoptic bronchoscopy
1 = only vocal cords visible; 2 = vocal cords plus posterior epiglottis visible; 3 = vocal cords plus anterior epiglottis visible; and 4 = vocal cords invisible
Measured: 0 minute afer successful insertion
Number of Participants with cranial nerve injury
Number of Participants with cranial nerve injury
Measured: 1hours after the surgery
Secondary outcomes (5)
Number of Participants with sore throat
Number of Participants with sore throat
Measured: 1hours after the surgery
Number of Participants with hoarseness
Number of Participants with hoarseness
Measured: 1hours after the surgery
Number of Participants with cough
Number of Participants with cough
Measured: 1hours after the surgery
Number of Participants with laryngospasm
Number of Participants with laryngospasm
Measured: 1hours after the surgery
Number of Participants with soft tissue injury
Number of Participants with soft tissue injury
Measured: 1hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start1 Oct 2021 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268043
- Sponsor's protocol ID
- 2019041-2
- Status last verified
- Aug 2021
- First submitted
- 11 Feb 2020
- Last updated
- 19 Aug 2021
- 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 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparation of Efficacy and Safety of Proseal Laryngeal Mask Airway With Flexible Laryngeal Airway Mask in Otitis Media Surgery
- ClinicalTrials.gov ID
- NCT04268043
- Acronym / sponsor ID
- 2019041-2
- Conditions
- Anesthesia Intubation Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 13 Feb 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.
Objective To investigate the comparative effect of proseal laryngeal mask airway and flexible laryngeal airway mask during otitis media surgery. Methods 200 patients of ASA I or II classification, 18-65 years old, BMI<30 kg/m2 undergoing otitis media surgery are randomly divided into two groups (Group P with proseal laryngeal mask airway and Group F with flexible laryngeal airway mask, respectively). After induction, selecting a appropriate size of LMA to patient,s weight, using the standard index finger-guided technique inserting the LMA, and then the patients were ventilated mechanically. The success rate of inserting laryngeal mask, the intubation time, surgery time and wake time were also recorded. Tidal volume and leakage pressure in patients with supine and lateral positioning were assessed respectively. The scale of fiberoptic bronchoscopy was also recorded to show airway exposure. Related complications such as sore throat, hoarseness, cough, laryngospasm, bloating, nausea and vomiting, soft tissue injury, blood residue after pulling out the LMA were analyzed.Postoperative voice and laryngopharyngeal symptom are also recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flexible laryngeal airway | Experimental | Device: flexible laryngeal airway mask |
| proseal laryngeal mask airway | Experimental | Device: proseal laryngeal mask airway |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of otitis media.
Key exclusion criteria (1 listed)
- Problems with the upper airway. Gastric carcinoma. Reflux esophagitis.
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 |
|---|---|---|
| flexible laryngeal airway maskVentilation with flexible laryngeal mask airway | Device | flexible laryngeal airway |
| proseal laryngeal mask airwayVentilation with proseal laryngeal mask airway | Device | proseal laryngeal mask airway |
Primary outcome
successful insert rate
Time frame: 0 minute after insertion
success rate of inserting laryngeal mask
tidal volume
Time frame: 5 minute afer successful insertion
tidal volume at 15cmH2O in patients with supine and lateral positioning
leakage pressure
Time frame: 5 minute afer successful insertion
leakage pressure in patients with supine and lateral positioning
The scale of fiberoptic bronchoscopy
Time frame: 0 minute afer successful insertion
1 = only vocal cords visible; 2 = vocal cords plus posterior epiglottis visible; 3 = vocal cords plus anterior epiglottis visible; and 4 = vocal cords invisible
Number of Participants with cranial nerve injury
Time frame: 1hours after the surgery
Number of Participants with cranial nerve injury
5 secondary outcomes
Number of Participants with sore throat
Time frame: 1hours after the surgery
Number of Participants with hoarseness
Time frame: 1hours after the surgery
Number of Participants with cough
Time frame: 1hours after the surgery
Number of Participants with laryngospasm
Time frame: 1hours after the surgery
Number of Participants with soft tissue injury
Time frame: 1hours after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
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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 flexible laryngeal airway mask and proseal laryngeal mask airway in people with Anesthesia Intubation Complication, run by Eye & ENT Hospital of Fudan 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: status not confirmed, as of the sponsor's last update on 19 Aug 2021. 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?
Results are not available in the source record.
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?
successful insert rate (time frame: 0 minute after insertion). The study lists 5 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 19 Aug 2021.