ObesityPhase 4NCT02439021
Effectiveness of the New Perilaryngeal Airway in Comparison With the Laryngeal Mask Airway
A Phase 4 study testing COBRA and LMA in people with Obesity, run by Qazvin University Of Medical Sciences.
Trial summary
The Laryngeal Mask Airway (LMA) has been used widely for different patients and found to be highly safe for adult and pediatric patients. However, the LMA has some limitations and weaknesses (e.g. more insertion attempts in 5% to 10 % of all cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- COBRA and LMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Jan 2013
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI between 25 to 35 kg/m2
- scheduled for surgery
- being older than 18 years
- Mallampati class I-III and BMI between 25 and 35
Who cannot join
- pregnancy
- morbid obese (BMI>35 kg/m2)
- a known difficult airway
- gastro-oesophageal reflux
- pharyngeal pathology
- emergency operation with full stomach
About this study
Official title: Effectiveness of the New Perilaryngeal Airway (CobraPLA™) in Comparison With the Laryngeal Mask Airway (LMA™) to Improve Oropharyngeal Leak Pressure Among Obese and Overweight Patients
The Laryngeal Mask Airway (LMA) has been used widely for different patients and found to be highly safe for adult and pediatric patients. However, the LMA has some limitations and weaknesses (e.g. more insertion attempts in 5% to 10 % of all cases. Despite the easy insertion of the LMA, it is crucial to check correct placement of the LMA airway.
- Conditions
- Obesity
- Being tested
- COBRA, LMA
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COBRADevice
LMADevice
| Study group | Role | What they receive |
|---|---|---|
| CobraPLA | Experimental | Patients will randomly assign to either LMA or Cobra PLATM Receives: Device: COBRA |
| LMA | Experimental | Patients will randomly assign to either LMA or Cobra PLATM Receives: Device: LMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak
Measured: Up to 1 hours
Time to intubation
Time to intubation was measured from inserting of the device to the patient's month while connecting the breathing circuit
Measured: Up to 1 hours
Secondary outcomes (4)
successful intubation attempt
A successful intubation attempt was recognized if: the breathing circuit connected, the EtCO2 trace was revealed, and no air leak was detected at airway pressures of 15 cm H2O
Measured: Up to 1 hours
incidence of sore throat
Measured: Up to 1 hours
incidence of dysphasia
Measured: Up to 1 hours
incidence of postoperative blood staining on mask
Measured: Up to 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startFeb 2012
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir H Pakpour, Qazvin University Of Medical Sciences
- Investigators
- Amir H Pakpour, PhD, Principal investigator, Qazvin University Of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439021
- Sponsor's protocol ID
- 653
- Status last verified
- May 2015
- First submitted
- 5 Feb 2015
- Last updated
- 8 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the New Perilaryngeal Airway (CobraPLA™) in Comparison With the Laryngeal Mask Airway (LMA™) to Improve Oropharyngeal Leak Pressure Among Obese and Overweight Patients
- ClinicalTrials.gov ID
- NCT02439021
- Acronym / sponsor ID
- 653
- Conditions
- Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jan 2013 (actual)
- First posted
- 8 May 2015 (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 Laryngeal Mask Airway (LMA) has been used widely for different patients and found to be highly safe for adult and pediatric patients. However, the LMA has some limitations and weaknesses (e.g. more insertion attempts in 5% to 10 % of all cases. Despite the easy insertion of the LMA, it is crucial to check correct placement of the LMA airway.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CobraPLA | Experimental | Device: COBRAPatients will randomly assign to either LMA or Cobra PLATM |
| LMA | Experimental | Device: LMAPatients will randomly assign to either LMA or Cobra PLATM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI between 25 to 35 kg/m2
- scheduled for surgery
- being older than 18 years
- Mallampati class I-III and BMI between 25 and 35
Key exclusion criteria (6 listed)
- pregnancy
- morbid obese (BMI>35 kg/m2)
- a known difficult airway
- gastro-oesophageal reflux
- pharyngeal pathology
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 |
|---|---|---|
| COBRA | Device | CobraPLA |
| LMA | Device | LMA |
Primary outcome
Oropharyngeal leak
Time frame: Up to 1 hours
Time to intubation
Time frame: Up to 1 hours
Time to intubation was measured from inserting of the device to the patient's month while connecting the breathing circuit
4 secondary outcomes
successful intubation attempt
Time frame: Up to 1 hours
incidence of sore throat
Time frame: Up to 1 hours
incidence of dysphasia
Time frame: Up to 1 hours
incidence of postoperative blood staining on mask
Time frame: Up to 1 hours
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 8 May 2015.
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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.
Amir H Pakpour, PhD principal investigator
Qazvin University Of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing COBRA and LMA in people with Obesity, run by Qazvin University Of Medical Sciences.
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 4 inclusion and 6 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 8 May 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Oropharyngeal leak (time frame: Up to 1 hours). The study lists 2 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 8 May 2015.