Laryngeal Masks ComparisonNCT04421261
Ventilation With Supraglottic Airway Devices
An observational study of Laryngeal Masks Comparison, run by Reham Ali Abdelhaleem Abdelrahman at 1 site in Egypt.
Trial summary
Airo-Q Self Pressurized airway device with Blocker will be compared with Proseal LMA in anesthetized adult female patients undergoing elective surgeries to discuss the influence of different head and neck positions on the performance of both devices. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Laryngeal Masks Comparison
- What is being tested?
- Air-Q Self Pressurized Airway Device with Blocker and Proseal Laryngeal Mask Airway
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Jun 2020to 1 Dec 2021
- Phase
- Observational
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Adult female patients who will be admitted through outpatient clinic of Kasr alainy hospitals
Who may be able to join
- Adult female patients ASA I\&II.
- age: 18-55 years old.
- BMI< 35.
- undergoing elective surgeries.
Who cannot join
- Patients with history of upper respiratory tract infections and obstructive sleep apnea.
- Patients who are potentially full stomach such as trauma, pregnancy, history of gastric regurgitation \&heart burn, those with esophageal reflux or hiatus hernia.
- Patients with coagulation disorders.
- Patients with El-Ganzouri airway score ≥ 5 will.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of anesthesia, Surgical ICU and Pain Management
Cairo, 11562
About this study
Official title: Evaluation of Performance of Air-Q Self Pressurized Airway Device With Blocker and Proseal Laryngeal Mask Airway at Different Head and Neck Positions in Anesthetized Paralyzed Adult Female Patients Undergoing Elective Gynecological Operations
Airo-Q Self Pressurized airway device with Blocker will be compared with Proseal LMA in anesthetized adult female patients undergoing elective surgeries to discuss the influence of different head and neck positions on the performance of both devices. Oropharyngeal leak pressure, peak inspiratory pressure, ventilation score and fiber-optic view will be assessed in neutral, flexion, extension and lateral positions in both groups.
- Conditions
- Laryngeal Masks Comparison
- Being tested
- Air-Q Self Pressurized Airway Device with Blocker, Proseal Laryngeal Mask Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air-Q Self Pressurized Airway Device with BlockerDevice
used in low risk adult females undergoing elective surgeries
Proseal Laryngeal Mask AirwayDevice
used in low risk adult female patients undergoing elective surgeries
| Study group | Role | What they receive |
|---|---|---|
| Air-Q Self Pressurized Airway Device with Blocker | Not described Receives: Device: Air-Q Self Pressurized Airway Device with Blocker | |
| Proseal Laryngeal Mask Airway | 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.
oropharyngeal leak pressure
pressure at which air leak starts to occur
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start4 Jun 2020
- Primary completion1 Jul 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal Masks ComparisonStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reham Ali Abdelhaleem Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reham Ali Abdelhaleem Abdelrahman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421261
- Sponsor's protocol ID
- KR-1990
- Status last verified
- Feb 2024
- First submitted
- 4 Jun 2020
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Performance of Air-Q Self Pressurized Airway Device With Blocker and Proseal Laryngeal Mask Airway at Different Head and Neck Positions in Anesthetized Paralyzed Adult Female Patients Undergoing Elective Gynecological Operations
- ClinicalTrials.gov ID
- NCT04421261
- Acronym / sponsor ID
- KR-1990
- Conditions
- Laryngeal Masks Comparison
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Reham Ali Abdelhaleem AbdelrahmanUniversity, hospital or other
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 9 Jun 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.
Airo-Q Self Pressurized airway device with Blocker will be compared with Proseal LMA in anesthetized adult female patients undergoing elective surgeries to discuss the influence of different head and neck positions on the performance of both devices. Oropharyngeal leak pressure, peak inspiratory pressure, ventilation score and fiber-optic view will be assessed in neutral, flexion, extension and lateral positions in both groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air-Q Self Pressurized Airway Device with Blocker | – | Device: Air-Q Self Pressurized Airway Device with Blocker |
| Proseal Laryngeal Mask Airway | – | Device: Proseal Laryngeal Mask Airway |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult female patients who will be admitted through outpatient clinic of Kasr alainy hospitals
Key inclusion criteria (4 listed)
- Adult female patients ASA I\&II.
- age: 18-55 years old.
- BMI< 35.
- undergoing elective surgeries.
Key exclusion criteria (4 listed)
- Patients with history of upper respiratory tract infections and obstructive sleep apnea.
- Patients who are potentially full stomach such as trauma, pregnancy, history of gastric regurgitation \&heart burn, those with esophageal reflux or hiatus hernia.
- Patients with coagulation disorders.
- Patients with El-Ganzouri airway score ≥ 5 will.
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 |
|---|---|---|
| Air-Q Self Pressurized Airway Device with Blockerused in low risk adult females undergoing elective surgeries | Device | Air-Q Self Pressurized Airway Device with Blocker |
| Proseal Laryngeal Mask Airwayused in low risk adult female patients undergoing elective surgeries | Device | Proseal Laryngeal Mask Airway |
Primary outcome
oropharyngeal leak pressure
Time frame: 1 year
pressure at which air leak starts to occur
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 Feb 2024.
Related trials for Laryngeal Masks Comparison
Not yet recruiting
Video Laryngeal Mask SaCoVLM Versus LMA Supreme and Ambu AuraGain in Children
Airway Management, Anesthesia, General
Not yet recruiting
SafeLM Versus LMA Classic for Airway Management During Fibroadenoma Excision
Airway Management
Not yet recruitingObservational study
Comparison of I-gel and SaCoVLM in Laparoscopic Cholecystectomy
Hemodynamic Monitoring, Laryngeal Mask Success Rate
Active, not recruiting
Comparison of Oropharyngeal Leak Pressures of SaCo Video Laryngeal Mask Airway (LMA) and ProSeal LMA in Adult Elective Surgery
Oropharengeal Leak Pressure
Recruiting
Comparison of Laryngeal Mask Airway Versus Endotracheal Intubation in Pediatric Laparoscopic Inguinal Hernia Repair
Inguinal Hernia Repair
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngeal Masks Comparison, run by Reham Ali Abdelhaleem Abdelrahman at 1 site in Egypt.
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 4 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 Feb 2024. 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 Egypt. 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?
oropharyngeal leak pressure (time frame: 1 year). 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 26 Feb 2024.