Airway ManagementLMANCT05920447
Safety and Limitation of the 2nd Generation Laryngeal Mask Airway in the Lithotomy Position: An Obsevational Study
An observational study of Airway Management, run by Ain Shams University at 1 site in Egypt.
Trial summary
Laryngeal mask airway is used in different types of surgery requiring different position, recommendation was raised regarding the use of LMA in Lithotomy position with pressure controlled mode of ventilation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Airway Management
- What is being tested?
- LMA
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jan 2021to 1 May 2023
- How long will I take part?
- 2 Days
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients in group L were intubated with an Igel LMA (Intersurgical) , the size was selected based on the body weight according to the manufacturer's instructions, the patients in group T were intubated with ETT (flexicare) size 7 for female and 8 for male The patients were then ventilated with a volume-controlled mode of ventilation at a Tidal Volume (TV) 7ml/kg, Respiratory Rate 12 /min, I: E 1:2. The patient was then positioned in the lithotomy position and secured Ventilatory parameters including expired TV, peak airway pressure, TV inspired- TV expired and the end-tidal CO2 were all monitored and recorded every 5 min. The incidence of aspiration as revealed clinically( witnessed vomiting followed by decreased oxygen saturation, increased airway pressure, tachycardia, etc..) and confirmed radiologically, Failure of insertion or intubation, sore throat and air leak were reported as a complications.
Who may be able to join
- Aged over 18 years
- Both gender
- Surgery mandating lithotomy position
Who cannot join
- Patients' refusal
- Pregnant women
- Obesity (BMI > 39)
- Trendelenburg position
- Moderate to severe GERD
- Lengthy procedures (more than 120 min)
Trial locations and contacts
1 site in 1 country.
About this study
Laryngeal mask airway is used in different types of surgery requiring different position, recommendation was raised regarding the use of LMA in Lithotomy position with pressure controlled mode of ventilation. This raise a concern whether the mode of ventilation is a limitation for the use of LMA in these position, especially with the use of the i-gel LMA with the characteristic non-inflatable jelly cuff, that provides an excellent seal.
- Conditions
- Airway Management
- Being tested
- LMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMADevice
Monitor the ventilatory parameter and incidence of complications
| Study group | Role | What they receive |
|---|---|---|
| ETT | the patients in group T were intubated with Endotracheal tube (ETT) (flexicare) size 7 for female and 8 for male The patients were ventilated with a volume-controlled mode at a Tidal Volume (TV) 7ml/kg, Respiratory Rate 12 /min, I: E 1:2. The patient was then positioned in the lithotomy position. Ventilatory parameters including expired TV, peak airway pressure, inspired- expired TV and the end-tidal carbon dioxide were all monitored and recorded every 5 min. In case of leaking from the LMA that interfere with the ventilation before the patients were being positioned in the lithotomy position, the patients were excluded and replaced by another. The incidence of aspiration as revealed clinically( witnessed vomiting followed by decreased oxygen saturation, increased airway pressure, tachycardia, etc..) and confirmed radiologically, Failure of insertion or intubation, sore throat and air leak were reported as a complications. | |
| LMA | The patients in group L were intubated with an I gel Laryngeal mask airway (LMA) , the size was selected based on the body weight according to the manufacturer's instructions,
The patients were then ventilated with a volume-controlled mode of ventilation at a Tidal Volume (TV) 7ml/kg, Respiratory Rate 12 /min, I: E 1:2. The patient was then positioned in the lithotomy position and secured
Ventilatory parameters including expired TV, peak airway pressure, TV inspired- TV expired and the end-tidal CO2 were all monitored and recorded every 5 min.
In case of leaking from the LMA that interfere with the ventilation before the patients were being positioned in the lithotomy position.
The incidence of aspiration as revealed clinically( witnessed vomiting followed by decreased oxygen saturation, increased airway pressure, tachycardia, etc..) and confirmed radiologically, Failure of insertion or intubation, sore throat and air leak were reported as a complications. Receives: Device: LMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety of volume-controlled mode of ventilation.in the Lithotomy position during the procedure
Measuring the air Leak through measuring the difference between the inspired and expired tidal volume and determine the peak airway pressure at which these leak does occur.
Measured: During the Procedure
Secondary outcomes (1)
THE incidence of complication among the two groups
decreased oxygen saturation, increased airway pressure, tachycardia, etc..) and confirmed radiologically, Failure of insertion or intubation, sore throat and air leak were reported as a complications.
Measured: through the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start24 Jan 2021
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920447
- Sponsor's protocol ID
- FMASU R 76/2021
- Acronym
- LMA
- Status last verified
- May 2023
- First submitted
- 26 May 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Limitation of the 2nd Generation Laryngeal Mask Airway in the Lithotomy Position: An Obsevational Study
- ClinicalTrials.gov ID
- NCT05920447
- Acronym / sponsor ID
- LMA / FMASU R 76/2021
- Conditions
- Airway Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 24 Jan 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 27 Jun 2023 (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.
Laryngeal mask airway is used in different types of surgery requiring different position, recommendation was raised regarding the use of LMA in Lithotomy position with pressure controlled mode of ventilation. This raise a concern whether the mode of ventilation is a limitation for the use of LMA in these position, especially with the use of the i-gel LMA with the characteristic non-inflatable jelly cuff, that provides an excellent seal.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETT | – | –the patients in group T were intubated with Endotracheal tube (ETT) (flexicare) size 7 for female and 8 for male The patients were ventilated with a volume-controlled mode at a Tidal Volume (TV) 7ml/kg, Respiratory Rate 12 /min, I: E 1:2. The patient was then positioned in the lithotomy position. Ventilatory parameters including expired TV, peak airway pressure, inspired- expired TV and the end-tidal carbon dioxide were all monitored and recorded every 5 min. In case of leaking from the LMA that interfere with the ventilation before the patients were being positioned in the lithotomy position, the patients were excluded and replaced by another. The incidence of aspiration as revealed clinically( witnessed vomiting followed by decreased oxygen saturation, increased airway pressure, tachycardia, etc..) and confirmed radiologically, Failure of insertion or intubation, sore throat and air leak were reported as a complications. |
| LMA | – | Device: LMAThe patients in group L were intubated with an I gel Laryngeal mask airway (LMA) , the size was selected based on the body weight according to the manufacturer's instructions, The patients were then ventilated with a volume-controlled mode of ventilation at a Tidal Volume (TV) 7ml/kg, Respiratory Rate 12 /min, I: E 1:2. The patient was then positioned in the lithotomy position and secured Ventilatory parameters including expired TV, peak airway pressure, TV inspired- TV expired and the end-tidal CO2 were all monitored and recorded every 5 min. In case of leaking from the LMA that interfere with the ventilation before the patients were being positioned in the lithotomy position. The incidence of aspiration as revealed clinically( witnessed vomiting followed by decreased oxygen saturation, increased airway pressure, tachycardia, etc..) and confirmed radiologically, Failure of insertion or intubation, sore throat and air leak were reported as a complications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients in group L were intubated with an Igel LMA (Intersurgical) , the size was selected based on the body weight according to the manufacturer's instructions, the patients in group T were intubated with ETT (flexicare) size 7 for female and 8 for male The patients were then ventilated with a volume-controlled mode of ventilation at a Tidal Volume (TV) 7ml/kg, Respiratory Rate 12 /min, I: E 1:2. The patient was then positioned in the lithotomy position and secured Ventilatory parameters including expired TV, peak airway pressure, TV inspired- TV expired and the end-tidal CO2 were all monitored and recorded every 5 min. The incidence of aspiration as revealed clinically( witnessed vomiting followed by decreased oxygen saturation, increased airway pressure, tachycardia, etc..) and confirmed radiologically, Failure of insertion or intubation, sore throat and air leak were reported as a complications.
Key inclusion criteria (3 listed)
- Aged over 18 years
- Both gender
- Surgery mandating lithotomy position
Key exclusion criteria (6 listed)
- Patients' refusal
- Pregnant women
- Obesity (BMI > 39)
- Trendelenburg position
- Moderate to severe GERD
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 |
|---|---|---|
| LMAMonitor the ventilatory parameter and incidence of complications | Device | LMA |
Primary outcome
Assess the safety of volume-controlled mode of ventilation.in the Lithotomy position during the procedure
Time frame: During the Procedure
Measuring the air Leak through measuring the difference between the inspired and expired tidal volume and determine the peak airway pressure at which these leak does occur.
1 secondary outcome
THE incidence of complication among the two groups
Time frame: through the procedure
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 27 Jun 2023.
- Individual participant dataSharing planned: No
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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 Airway Management, run by Ain Shams University 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 3 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 27 Jun 2023. 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?
Assess the safety of volume-controlled mode of ventilation.in the Lithotomy position during the procedure (time frame: During the Procedure). 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 27 Jun 2023.