Airway RemodelingNCT04765761
Proseal Laryngeal Mask Airway With or Without Introducer-tool Stabilization for Pressure Controlled Ventilation
A study testing PLMA with introducer and PLMA without introducer in people with Airway Remodeling, run by Sir Ganga Ram Hospital at 1 site in India.
Trial summary
ProSeal laryngeal mask airway (PLMA) has become an effective alternative to tracheal tube for gaining airway access and for the institution and maintenance of positive pressure ventilation (PPV) in patients undergoing short-to-moderate duration (20-60 minutes) surgery under GA. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Airway Remodeling
- What is being tested?
- PLMA with introducer and PLMA without introducer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteIndia
- Study dates
- 3 Mar 2021to 16 Mar 2022
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20 - 60 years.
- ASA physical status I and II.
Who cannot join
- Patients having complaints of acid-peptic disease, chronic constipation, feeling of stomach fullness after meal.
- Previous gastrointestinal surgery
- History of hiatus hernia
- Known case of substance abuse or chronic alcoholism
- Psychiatric illness
- Pregnant patients
Show all 12Show fewer
- Anatomical defects of the mandible.
- Dental problems (Missing teeth, loose teeth)
- Surgery requiring Trendelenburg position.
- Surgery requiring position change during procedure
- Morbid obesity with OSAS.
- Failure to obtain consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Proseal Laryngeal Mask Airway With or Without Introducer-tool Stabilization for Pressure Controlled Ventilation in Adults Undergoing Elective Surgery: a Randomized Controlled Study
ProSeal laryngeal mask airway (PLMA) has become an effective alternative to tracheal tube for gaining airway access and for the institution and maintenance of positive pressure ventilation (PPV) in patients undergoing short-to-moderate duration (20-60 minutes) surgery under GA. The PLMA is the more preferred supra-glottic airway access device for advantages therein over the other SGA's, including having an option of dedicated introducer-tool (ease of placement), availability of esophageal opening (allows regurgitated fluid to bypass the airway), and reinforced main body tube (prevents luminal compression). Additionally, as compared to other supra-glottic airway devices, the PLMA device has been found to be more consistent in providing PPV to patients' lungs during GA. However, not uncommonly, PLMA itself is not consistent in maintaining trouble-free PPV owing to the vulnerability to position change, especially secondary to the rhythmic movement posited by back pressure during PPV. This movement vulnerability induced by PPV may be because of the size/shape of PLMA cuff that does fit upon placement but gets vulnerable to undue movement during PPV.
We hypothesize that keeping the introducer-tool in position after insertion of PLMA result in greater stabilization of PLMA in position by minimizing the movement that occurs due to back-pressure effect on the cuff during positive pressure ventilation. This randomized study intends to evaluate whether keeping the introducer-tool in position (after PLMA insertion) accords greater positional stabilization to the PLMA and thereby offers greater efficacy for achieving adequate pressure control ventilation in paralyzed anesthetized adults undergoing elective surgery.
Read the detailed description
Supraglottic airways (SGA) have become a standard proposition in management of the upper airway. These devices have suitably interposed its utility as airway conduit between the facemask and the tracheal tube in terms of anatomical position and degree of invasiveness. These devices sit outside of trachea but provide a hands-free means of achieving a gas-tight airway. In the year 1989, the first SGA, the classic laryngeal mask airway (C-LMA), became available. As time went on, additional variants of LMA came into use.
The ProSeal Laryngeal mask airway (PLMA), introduced in 2000, is by far the most specialized SGA device. It comprises of four main subparts: the cuff, inflation line with pilot balloon, airway tube, and the gastric drain tube. All components are made of silicone and are latex-free. Studies indicate that size 3/4 is most preferable for adult women and size 4/5 for adult men.
The airway (breathing, ventilation) tube of the PLMA is shorter and smaller in diameter than its C-LMA counterpart. PLMA's wire-reinforced body makes it more flexible and yet resistant to luminal compression. The locating-strap on the anterior distal tube of PLMA prevents finger slipping off the tube and also provides an insertion slot for an 'introducer-tool'. An additional safety accessory vent under the drainage tube in the bowl help avoid secretions from pooling and accessing the upper airway. The PLMA has a deeper bowl than C-LMA and has a bite-block between the airway and drain tubes at the level of teeth to prevent device injury.
In a correctly positioned PLMA, the cuff tip lies behind the cricoid cartilage at the origin of the esophagus; allows liquids/gases a bypass escape from the stomach and reduces the risk of gastric insufflation, regurgitation and pulmonary aspiration; and provides information about the PLMA position. The drain tube is designed to prevent the epiglottis from occluding the airway tube, thus eliminating the need for aperture bars. A gastric tube, doppler probe, temperature probe can be passed into the oesophagus through the drainage port.
The PLMA also has a second dorsal cuff which pushes the mask anteriorly to provide a better seal around the glottic aperture.
As per the standard guidelines, an introducer-tool (a curved, malleable, silicone-coated blade with a guiding handle) is used to facilitate placing an PLMA in the pharyngo-laryngeal slot, and helps greatly with the first-insertion placement success.
Once in place, the PLMA offers a dependable conduit through which effective PPV can be instituted. Interestingly, although the PLMA placement and position adequacy has a static corollary to it and that the institution of PPV situates a dynamic airflow system; not uncommonly, there are problems to effective PPV even through an adequately placed PLMA. The rhythmic PPV which leads to back pressure onto the PLMA cuff often result in subtle cuff movements resulting in leak at the desired PPV pressure.
Based on past clinical data in unit regarding safety of this procedure we hypothesize that keeping the introducer-tool in position (after facilitating insertion of PLMA) minimizes unwanted position changes owing to back pressure effect of PPV on the PLMA cuff, and therefore, would enable us to achieve and maintain adequate ventilation during GA.
We plan this study with an objective to compare efficacy of PLMA with or without introducer tool assisted stabilization during PPV in anaesthetized paralyzed patients undergoing short to moderate duration surgery.
- Conditions
- Airway Remodeling
- Being tested
- PLMA with introducer, PLMA without introducer
- Medical subject headings
- Airway Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLMA with introducerDevice
The pro-seal laryngeal mask airway (PLMA) will be inserted along with introducer tool which will be kept in-situ throughout the duration of positive pressure ventilation
PLMA without introducerDevice
The pro-seal laryngeal mask airway (PLMA) will be inserted along with introducer tool which will be removed after insertion and patient will be ventilated using PLMA without the introducer in-situ throughout the duration of positive pressure ventilation
| Study group | Role | What they receive |
|---|---|---|
| PLMA with Introducer' | Active comparator | PLMA placed in position with the help of the introducer-tool and then the introducer-tool retained in place throughout the institution and duration of positive pressure ventilation. Receives: Device: PLMA with introducer |
| PLMA without Introducer | Active comparator | PLMA placed in position with the help of the introducer-tool and then the introducer-tool removed before institution of positive pressure ventilation. Receives: Device: PLMA without introducer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal Seal pressure of the PLMA
Oropharyngeal seal pressure (in cmH2O) will be measured by closing the expiratory valve of the anaesthetic circle system at a fixed gas flow rate of 3L/min, and noting the equilibrated upper airway pressure
Measured: From time of insertion of PLMA till 120-minutes intraoperatively
Secondary outcomes (6)
Efficiency of positive pressure ventilation (PPV)
It will be determined by calculating the tidal volume generated on institution of PPV and pressures (cmH2O) required to achieve 10ml /kg tidal volume through PLMA.
Measured: From time of insertion of PLMA till 120-minutes intraoperatively
Postoperative sore throat
The presence of sore throat will be graded on a two-point scale; 0: sore throat absent, 1: sore throat present
Measured: From end of surgery till 24 hours postoperatively
Postoperative cough
The presence of cough will be graded on a two-point scale; 0: cough absent, 1: cough present
Measured: From end of surgery till 24 hours postoperatively
Postoperative difficulty in swallowing
The presence of difficulty in swallowing will be graded on a two-point scale; 0: difficulty in swallowing absent, 1: difficulty in swallowing present
Measured: From end of surgery till 24 hours postoperatively
Postoperative difficulty in speaking
The presence of difficulty in speaking will be graded on a two-point scale; 0: difficulty in speaking absent, 1: difficulty in speaking present
Measured: From end of surgery till 24 hours postoperatively
Quantitative assessment of positive pressure ventilation (PPV)
The positive pressure ventilation will be adjudicated as "trouble-free PPV" if there is no leak and the tidal ventilation is achieved (as reflected by consistent EtCO2 tracings) with standardized ventilation parameters (f- 14, I:E- 1:2, Inspiratory pressure- 20cm H20).
The positive pressure ventilation will be adjudicated as "trouble-prone PPV" if there is a leak around PLMA and the tidal ventilation could not be achieved with standardized ventilation parameters (frequency- 14, I:E- 1:2, Inspiratory pressure- 20cm H20) but can finally be achieved with routine adjustments.
The positive pressure ventilation will be adjudicated as ''failed positive pressure ventilation'' wherein it is not possible to establish PPV through the PLMA conduit despite maximum adjustments
Measured: From time of insertion of PLMA till 120-minutes intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start3 Mar 2021
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway RemodelingStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly allocated into 2-groups. Group-1 will be the 'PLMA with Introducer' group and group-2 will be the 'PLMA without Introducer' group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Ganga Ram Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nitin Sethi, DNB, Sir Ganga Ram Hospital
- Investigators
- Rakesh Saxena, MBBS, MD, Study chair, Sir Ganga Ram Hospital, New Delhi, INDIAAmitabh Dutta, MD, PGDHR, Principal investigator, Sir Ganga Ram Hospital, New Delhi, INDIAAbishek SS, Principal investigator, Sir Ganga Ram Hospital, New Delhi, INDIAManish Kohli, DA, DNB, Principal investigator, Sir Ganga Ram Hospital, New Delhi, INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765761
- Sponsor's protocol ID
- EC/01/21/1800
- Status last verified
- Aug 2023
- First submitted
- 17 Feb 2021
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Proseal Laryngeal Mask Airway With or Without Introducer-tool Stabilization for Pressure Controlled Ventilation in Adults Undergoing Elective Surgery: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04765761
- Acronym / sponsor ID
- EC/01/21/1800
- Conditions
- Airway Remodeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Sir Ganga Ram HospitalUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 21 Feb 2021 (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.
ProSeal laryngeal mask airway (PLMA) has become an effective alternative to tracheal tube for gaining airway access and for the institution and maintenance of positive pressure ventilation (PPV) in patients undergoing short-to-moderate duration (20-60 minutes) surgery under GA. The PLMA is the more preferred supra-glottic airway access device for advantages therein over the other SGA's, including having an option of dedicated introducer-tool (ease of placement), availability of esophageal opening (allows regurgitated fluid to bypass the airway), and reinforced main body tube (prevents luminal compression). Additionally, as compared to other supra-glottic airway devices, the PLMA device has been found to be more consistent in providing PPV to patients' lungs during GA. However, not uncommonly, PLMA itself is not consistent in maintaining trouble-free PPV owing to the vulnerability to position change, especially secondary to the rhythmic movement posited by back pressure during PPV. This movement vulnerability induced by PPV may be because of the size/shape of PLMA cuff that does fit upon placement but gets vulnerable to undue movement during PPV.
We hypothesize that keeping the introducer-tool in position after insertion of PLMA result in greater stabilization of PLMA in position by minimizing the movement that occurs due to back-pressure effect on the cuff during positive pressure ventilation. This randomized study intends to evaluate whether keeping the introducer-tool in position (after PLMA insertion) accords greater positional stabilization to the PLMA and thereby offers greater efficacy for achieving adequate pressure control ventilation in paralyzed anesthetized adults undergoing elective surgery.
Detailed description
Supraglottic airways (SGA) have become a standard proposition in management of the upper airway. These devices have suitably interposed its utility as airway conduit between the facemask and the tracheal tube in terms of anatomical position and degree of invasiveness. These devices sit outside of trachea but provide a hands-free means of achieving a gas-tight airway. In the year 1989, the first SGA, the classic laryngeal mask airway (C-LMA), became available. As time went on, additional variants of LMA came into use.
The ProSeal Laryngeal mask airway (PLMA), introduced in 2000, is by far the most specialized SGA device. It comprises of four main subparts: the cuff, inflation line with pilot balloon, airway tube, and the gastric drain tube. All components are made of silicone and are latex-free. Studies indicate that size 3/4 is most preferable for adult women and size 4/5 for adult men.
The airway (breathing, ventilation) tube of the PLMA is shorter and smaller in diameter than its C-LMA counterpart. PLMA's wire-reinforced body makes it more flexible and yet resistant to luminal compression. The locating-strap on the anterior distal tube of PLMA prevents finger slipping off the tube and also provides an insertion slot for an 'introducer-tool'. An additional safety accessory vent under the drainage tube in the bowl help avoid secretions from pooling and accessing the upper airway. The PLMA has a deeper bowl than C-LMA and has a bite-block between the airway and drain tubes at the level of teeth to prevent device injury.
In a correctly positioned PLMA, the cuff tip lies behind the cricoid cartilage at the origin of the esophagus; allows liquids/gases a bypass escape from the stomach and reduces the risk of gastric insufflation, regurgitation and pulmonary aspiration; and provides information about the PLMA position. The drain tube is designed to prevent the epiglottis from occluding the airway tube, thus eliminating the need for aperture bars. A gastric tube, doppler probe, temperature probe can be passed into the oesophagus through the drainage port.
The PLMA also has a second dorsal cuff which pushes the mask anteriorly to provide a better seal around the glottic aperture.
As per the standard guidelines, an introducer-tool (a curved, malleable, silicone-coated blade with a guiding handle) is used to facilitate placing an PLMA in the pharyngo-laryngeal slot, and helps greatly with the first-insertion placement success.
Once in place, the PLMA offers a dependable conduit through which effective PPV can be instituted. Interestingly, although the PLMA placement and position adequacy has a static corollary to it and that the institution of PPV situates a dynamic airflow system; not uncommonly, there are problems to effective PPV even through an adequately placed PLMA. The rhythmic PPV which leads to back pressure onto the PLMA cuff often result in subtle cuff movements resulting in leak at the desired PPV pressure.
Based on past clinical data in unit regarding safety of this procedure we hypothesize that keeping the introducer-tool in position (after facilitating insertion of PLMA) minimizes unwanted position changes owing to back pressure effect of PPV on the PLMA cuff, and therefore, would enable us to achieve and maintain adequate ventilation during GA.
We plan this study with an objective to compare efficacy of PLMA with or without introducer tool assisted stabilization during PPV in anaesthetized paralyzed patients undergoing short to moderate duration surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomly allocated into 2-groups. Group-1 will be the 'PLMA with Introducer' group and group-2 will be the 'PLMA without Introducer' group.
| Arm | Type | Receives |
|---|---|---|
| PLMA with Introducer' | Active comparator | Device: PLMA with introducerPLMA placed in position with the help of the introducer-tool and then the introducer-tool retained in place throughout the institution and duration of positive pressure ventilation. |
| PLMA without Introducer | Active comparator | Device: PLMA without introducerPLMA placed in position with the help of the introducer-tool and then the introducer-tool removed before institution of positive pressure ventilation. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 20 - 60 years.
- ASA physical status I and II.
Key exclusion criteria (12 listed)
- Patients having complaints of acid-peptic disease, chronic constipation, feeling of stomach fullness after meal.
- Previous gastrointestinal surgery
- History of hiatus hernia
- Known case of substance abuse or chronic alcoholism
- Psychiatric illness
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 |
|---|---|---|
| PLMA with introducerThe pro-seal laryngeal mask airway (PLMA) will be inserted along with introducer tool which will be kept in-situ throughout the duration of positive pressure ventilation | Device | PLMA with Introducer' |
| PLMA without introducerThe pro-seal laryngeal mask airway (PLMA) will be inserted along with introducer tool which will be removed after insertion and patient will be ventilated using PLMA without the introducer in-situ throughout the duration of positive pressure ventilation | Device | PLMA without Introducer |
Primary outcome
Oropharyngeal Seal pressure of the PLMA
Time frame: From time of insertion of PLMA till 120-minutes intraoperatively
Oropharyngeal seal pressure (in cmH2O) will be measured by closing the expiratory valve of the anaesthetic circle system at a fixed gas flow rate of 3L/min, and noting the equilibrated upper airway pressure
6 secondary outcomes
Efficiency of positive pressure ventilation (PPV)
Time frame: From time of insertion of PLMA till 120-minutes intraoperatively
Postoperative sore throat
Time frame: From end of surgery till 24 hours postoperatively
Postoperative cough
Time frame: From end of surgery till 24 hours postoperatively
Postoperative difficulty in swallowing
Time frame: From end of surgery till 24 hours postoperatively
Postoperative difficulty in speaking
Time frame: From end of surgery till 24 hours postoperatively
Quantitative assessment of positive pressure ventilation (PPV)
Time frame: From time of insertion of PLMA till 120-minutes intraoperatively
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 15 Aug 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.
Rakesh Saxena, MBBS, MD study chair
Sir Ganga Ram Hospital, New Delhi, INDIA
Amitabh Dutta, MD, PGDHR principal investigator
Sir Ganga Ram Hospital, New Delhi, INDIA
Abishek SS principal investigator
Sir Ganga Ram Hospital, New Delhi, INDIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLMA with introducer and PLMA without introducer in people with Airway Remodeling, run by Sir Ganga Ram Hospital at 1 site in India.
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 2 inclusion and 12 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 15 Aug 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 India. 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 Seal pressure of the PLMA (time frame: From time of insertion of PLMA till 120-minutes intraoperatively). 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 15 Aug 2023.