Airway Complication of AnaesthesiaNCT01909297
Comparison of the I-gel, Supreme and Proseal LMA in Paralyzed Patients
A study testing PROSEAL LMA, SUPREMA LMA and I-GEL LMA in people with Airway Complication of Anaesthesia, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to compare of the i-gel, supreme and proseal laryngeal mask airways in paralysed patients undergoing gynaecological laparoscopic surgery with oropharyngeal leak pressure. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Airway Complication of Anaesthesia
- What is being tested?
- PROSEAL LMA, SUPREMA LMA and I-GEL LMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2013to Jul 2013
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18- 60 YEARS
Who cannot join
- ASA 3-4 patients
- BMI 40
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the I-gel, Supreme and Proseal LMA in Paralyzed Patients Undergoing Gynaecological Laparoscopic Surgery With Oropharyngeal Leak Pressure
The investigators aimed to compare of the i-gel, supreme and proseal laryngeal mask airways in paralysed patients undergoing gynaecological laparoscopic surgery with oropharyngeal leak pressure. The investigators also studied their relative ease of insertion, time to insertion and complications of use as secondary outcome measures.
Read the detailed description
A total of 105 patients scheduled for elective gynaecological laparoscopic procedures in our Inonu University Medical Faculty Hospital were recruited.They were equally randomized into three groups: PLMA, supreme and i-gel groups. All three devices were compared with regard to oropharyngeal leak pressure, number and duration of insertion attempts and complications of airway. Oropharyngeal leak pressure will evaluate including to start,trendelenburg and postoperative at period. Fiberoptic evaluation of the LMA's position were performed after successful insertion and determination of the airway pressures. After one hour patients were evaluated by a blinded independent observer for postoperative complications ( sore throat, dysphonia and dysphagia).
- Conditions
- Airway Complication of Anaesthesia
- Being tested
- PROSEAL LMA, SUPREMA LMA, I-GEL LMA
- Keywords
- airway management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROSEAL LMADevice
Size 3,4 or 5 supraglottic device with orogastric drainage tube
SUPREMA LMADevice
Size 3,4 or 5, disposable supraglottic device with orogastric drainage tube
I-GEL LMADevice
Size 3,4,5 disposable supraglottic device with noninflatable cuff
| Study group | Role | What they receive |
|---|---|---|
| ProSeal LMA | Active comparator | Supraglottic airway device Receives: Device: PROSEAL LMA |
| suprema LMA | Active comparator | Supraglottic airway device Receives: Device: SUPREMA LMA |
| I-gel LMA | Active comparator | Supraglottic airway device Receives: Device: I-GEL LMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of oropharyngeal leak pressure
During intraoperative period, oropharyngeal leak pressure was measured at three times (10min, 30 min, and 45 min after insertion of devices)
Measured: 10min, 30 min ,45 min
Secondary outcomes (1)
easiness of insertion of the device
During insertion, easiness of the devices were evaluated by a scale
Measured: 2 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2013
- Study completionJul 2013
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 Airway Complication of AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mukadder Sanli, Inonu University
- Investigators
- mukadder sanli, MD, Principal investigator, Assistant Prof Dr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909297
- Sponsor's protocol ID
- 2011/188
- Status last verified
- Jul 2013
- First submitted
- 21 Jun 2013
- Last updated
- 26 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Singh I, Gupta M, Tandon M. Comparison of Clinical Performance of I-Gel with LMA-Proseal in Elective Surgeries. Indian J Anaesth. 2009 Jun;53(3):302-5.
PubMed 20640137
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the I-gel, Supreme and Proseal LMA in Paralyzed Patients Undergoing Gynaecological Laparoscopic Surgery With Oropharyngeal Leak Pressure
- ClinicalTrials.gov ID
- NCT01909297
- Acronym / sponsor ID
- 2011/188
- Conditions
- Airway Complication of Anaesthesia
- Keywords
- airway management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 26 Jul 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.
The investigators aimed to compare of the i-gel, supreme and proseal laryngeal mask airways in paralysed patients undergoing gynaecological laparoscopic surgery with oropharyngeal leak pressure. The investigators also studied their relative ease of insertion, time to insertion and complications of use as secondary outcome measures.
Detailed description
A total of 105 patients scheduled for elective gynaecological laparoscopic procedures in our Inonu University Medical Faculty Hospital were recruited.They were equally randomized into three groups: PLMA, supreme and i-gel groups. All three devices were compared with regard to oropharyngeal leak pressure, number and duration of insertion attempts and complications of airway. Oropharyngeal leak pressure will evaluate including to start,trendelenburg and postoperative at period. Fiberoptic evaluation of the LMA's position were performed after successful insertion and determination of the airway pressures. After one hour patients were evaluated by a blinded independent observer for postoperative complications ( sore throat, dysphonia and dysphagia).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ProSeal LMA | Active comparator | Device: PROSEAL LMASupraglottic airway device |
| suprema LMA | Active comparator | Device: SUPREMA LMASupraglottic airway device |
| I-gel LMA | Active comparator | Device: I-GEL LMASupraglottic airway device |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18- 60 YEARS
Key exclusion criteria (2 listed)
- ASA 3-4 patients
- BMI 40
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 |
|---|---|---|
| PROSEAL LMASize 3,4 or 5 supraglottic device with orogastric drainage tube | Device | ProSeal LMA |
| SUPREMA LMASize 3,4 or 5, disposable supraglottic device with orogastric drainage tube | Device | suprema LMA |
| I-GEL LMASize 3,4,5 disposable supraglottic device with noninflatable cuff | Device | I-gel LMA |
Primary outcome
change of oropharyngeal leak pressure
Time frame: 10min, 30 min ,45 min
During intraoperative period, oropharyngeal leak pressure was measured at three times (10min, 30 min, and 45 min after insertion of devices)
1 secondary outcome
easiness of insertion of the device
Time frame: 2 min
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 26 Jul 2013.
- Results publication: PubMed 20640137Singh I, Gupta M, Tandon M. Comparison of Clinical Performance of I-Gel with LMA-Proseal in Elective Surgeries. Indian J Anaesth. 2009 Jun;53(3):302-5.
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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.
mukadder sanli, MD principal investigator
Assistant Prof Dr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROSEAL LMA, SUPREMA LMA and I-GEL LMA in people with Airway Complication of Anaesthesia, run by Inonu University at 1 site in Turkey (Türkiye).
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 2 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 26 Jul 2013. 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 Turkey (Türkiye). 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?
change of oropharyngeal leak pressure (time frame: 10min, 30 min ,45 min). 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 NCT01909297, 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 26 Jul 2013.