Proseal Laryngeal Mask Airway With or Without Introducer-tool Stabilization for Pressure Controlled Ventilation

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.

Study Overview

• Status: Completed
• Conditions: Airway Remodeling
• Intervention / Treatment: Device: PLMA with introducer; Device: PLMA without introducer

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110060
      • Nitin Sethi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 20 - 60 years.
2. ASA physical status I and II.

Exclusion Criteria:

1. Patients having complaints of acid-peptic disease, chronic constipation, feeling of stomach fullness after meal.
2. Previous gastrointestinal surgery
3. History of hiatus hernia
4. Known case of substance abuse or chronic alcoholism
5. Psychiatric illness
6. Pregnant patients
7. Anatomical defects of the mandible.
8. Dental problems (Missing teeth, loose teeth)
9. Surgery requiring Trendelenburg position.
10. Surgery requiring position change during procedure
11. Morbid obesity with OSAS.
12. Failure to obtain consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PLMA with Introducer'; 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.	Device: PLMA with introducer; 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
Active Comparator: PLMA without Introducer; PLMA placed in position with the help of the introducer-tool and then the introducer-tool removed before institution of positive pressure ventilation.	Device: PLMA without introducer; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From time of insertion of PLMA till 120-minutes intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From time of insertion of PLMA till 120-minutes intraoperatively
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.	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	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	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	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	From end of surgery till 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Sir Ganga Ram Hospital
• Investigators: Study Chair: Rakesh Saxena, MBBS, MD, Sir Ganga Ram Hospital, New Delhi, INDIA; Principal Investigator: Amitabh Dutta, MD, PGDHR, Sir Ganga Ram Hospital, New Delhi, INDIA; Principal Investigator: Abishek SS, Sir Ganga Ram Hospital, New Delhi, INDIA; Principal Investigator: Manish Kohli, DA, DNB, Sir Ganga Ram Hospital, New Delhi, INDIA

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Actual): March 16, 2022
• Study Completion (Actual): March 16, 2022

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Airway Remodeling
• Other Study ID Numbers: EC/01/21/1800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No