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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

India1 site
  • Nitin Sethi

    New Delhi, National Capital Territory of Delhi, 110060

Other trials in India

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.

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 groups in NCT04765761
Study groupRoleWhat they receive
PLMA with Introducer'Active comparatorPLMA 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 IntroducerActive comparatorPLMA 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted21 Feb 2021
  2. Study start3 Mar 2021
  3. Primary completion16 Mar 2022
  4. Study completion16 Mar 2022

Resources

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)
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

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.

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