Laryngeal Masks ComparisonNCT03384056
Respiration and The Airway With Supraglottic Airway Devices
An observational study of Laryngeal Masks Comparison, run by Reham Ali Abdelhaleem Abdelrahman at 1 site in Egypt.
Trial summary
The investigators aim to compare the airway seal pressure( oropharyngeal leak pressure) of the Self Pressurized Airway Device with Blocker® with the ProsealTM Laryngeal Mask Airway (P-LMA)in anesthetized paralyzed adult female patients undergoing elective gynecological operations. 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?
- Self Pressurized Airway Device with Blocker and Proseal Laryngeal Mask Airway
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 1 Nov 2019
- 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 undergoing elective gynecological operations.
Who may be able to join
- Adult female patients ASA I\&II
- Age: 18- 55 years old
- BMI < 35
- Undergoing elective gynecological operations.
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: Comparison of Air-Q Self Pressurized Airway Device With Blocker With Proseal Laryngeal Mask Airway in Anesthetized Paralyzed Adult Female Patients Undergoing Elective Gynecological Operations
The investigators aim to compare the airway seal pressure( oropharyngeal leak pressure) of the Self Pressurized Airway Device with Blocker® with the ProsealTM Laryngeal Mask Airway (P-LMA)in anesthetized paralyzed adult female patients undergoing elective gynecological operations. The investigators aim at assessment of fitting of both devices against the glottic region that detected by the flexible fiberoptic bronchoscope( Pentex Corporation, Medical Division, Singapore)and assessment of any associated postoperative complications.
Hypothesis:
The investigators hypothesize that the self-pressurized air-Q with blocker has a greater seal pressure compared to Proseal, easier and faster in insertion with less morbidity and complications during and after its insertion.
Read the detailed description
The study will be carried on adult female patients to reduce variability in size of the chosen device to enable the investigators to analyze the performance parameters of the two devices with greater authority. The study will be done on anesthetized paralyzed adult female patients undergoing elective gynecological operations that require neuromuscular block but not necessarily tracheal intubation. The investigators will recruit 150 adult female(18-55 years old, ASAI\&II) patients to a prospective randomized comparative controlled two-arm parallel clinical trial. Patients with history of upper respiratory tract infections, obstructive sleep apnea, potentially full stomach (trauma, morbid obesity BMI> 35, pregnancy, history of gastric regurgitation and heart burn), those with esophageal reflux (hiatus hernia), and those of coagulation disorders will be excluded from the study. All patients will be assessed pre-operatively El-Ganzouri airway score to assess the expected difficulty of intubation and patients with airway scores ≥ 5 will be excluded from the study. The patients will be randomly allocated into two groups(the SP-Blocker group \& the P-LMA group; each group is 75 patients) using computer generated program . An online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into the study groups. Random allocation numbers will be concealed in opaque closed envelops. The patient and investigator assessing study outcomes will all be blinded to the study groups allocation.
- Conditions
- Laryngeal Masks Comparison
- Being tested
- 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.
Self Pressurized Airway Device with BlockerDevice
used in adult low risk females undergoing elective gynecological operations
Proseal Laryngeal Mask AirwayDevice
used in adult low risk females undergoing elective gynecological operations.
| Study group | Role | What they receive |
|---|---|---|
| Self Pressurized Airway Device with Blocker | Not described Receives: Device: 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.
airway seal pressure
pressure at which leak starts to occur
Measured: one year
fitting of the device against larynx
detected by the flexible fiberoptic
Measured: one year
Secondary outcomes (1)
insertion time of the device
is defined as time in seconds from the chosen device touching the teeth to the first recorded near rectangular capnogram curve in the presence of satisfactory bilateral chest expansion.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start1 Feb 2018
- Primary completion1 Oct 2019
- Study completion1 Nov 2019
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
- 150 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
- NCT03384056
- Sponsor's protocol ID
- AR-1974
- Status last verified
- Aug 2021
- First submitted
- 14 Dec 2017
- Last updated
- 25 Aug 2021
- 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 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Air-Q Self Pressurized Airway Device With Blocker With Proseal Laryngeal Mask Airway in Anesthetized Paralyzed Adult Female Patients Undergoing Elective Gynecological Operations
- ClinicalTrials.gov ID
- NCT03384056
- Acronym / sponsor ID
- AR-1974
- Conditions
- Laryngeal Masks Comparison
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Reham Ali Abdelhaleem AbdelrahmanUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 27 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 aim to compare the airway seal pressure( oropharyngeal leak pressure) of the Self Pressurized Airway Device with Blocker® with the ProsealTM Laryngeal Mask Airway (P-LMA)in anesthetized paralyzed adult female patients undergoing elective gynecological operations. The investigators aim at assessment of fitting of both devices against the glottic region that detected by the flexible fiberoptic bronchoscope( Pentex Corporation, Medical Division, Singapore)and assessment of any associated postoperative complications.
Hypothesis:
The investigators hypothesize that the self-pressurized air-Q with blocker has a greater seal pressure compared to Proseal, easier and faster in insertion with less morbidity and complications during and after its insertion.
Detailed description
The study will be carried on adult female patients to reduce variability in size of the chosen device to enable the investigators to analyze the performance parameters of the two devices with greater authority. The study will be done on anesthetized paralyzed adult female patients undergoing elective gynecological operations that require neuromuscular block but not necessarily tracheal intubation. The investigators will recruit 150 adult female(18-55 years old, ASAI\&II) patients to a prospective randomized comparative controlled two-arm parallel clinical trial. Patients with history of upper respiratory tract infections, obstructive sleep apnea, potentially full stomach (trauma, morbid obesity BMI> 35, pregnancy, history of gastric regurgitation and heart burn), those with esophageal reflux (hiatus hernia), and those of coagulation disorders will be excluded from the study. All patients will be assessed pre-operatively El-Ganzouri airway score to assess the expected difficulty of intubation and patients with airway scores ≥ 5 will be excluded from the study. The patients will be randomly allocated into two groups(the SP-Blocker group \& the P-LMA group; each group is 75 patients) using computer generated program . An online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into the study groups. Random allocation numbers will be concealed in opaque closed envelops. The patient and investigator assessing study outcomes will all be blinded to the study groups allocation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self Pressurized Airway Device with Blocker | – | Device: 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 undergoing elective gynecological operations.
Key inclusion criteria (4 listed)
- Adult female patients ASA I\&II
- Age: 18- 55 years old
- BMI < 35
- Undergoing elective gynecological operations.
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 |
|---|---|---|
| Self Pressurized Airway Device with Blockerused in adult low risk females undergoing elective gynecological operations | Device | Self Pressurized Airway Device with Blocker |
| Proseal Laryngeal Mask Airwayused in adult low risk females undergoing elective gynecological operations. | Device | Proseal Laryngeal Mask Airway |
Primary outcome
airway seal pressure
Time frame: one year
pressure at which leak starts to occur
fitting of the device against larynx
Time frame: one year
detected by the flexible fiberoptic
1 secondary outcome
insertion time of the device
Time frame: one year
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 25 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.
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 25 Aug 2021. 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?
airway seal pressure (time frame: one year). 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 25 Aug 2021.