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

NCT04765761 | Completed DMC

• 1 other identifier: EC/01/21/1800
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Airway Remodeling

Outcome Measures

Primary Outcomes (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

  From time of insertion of PLMA till 120-minutes intraoperatively

Secondary Outcomes (6)

• Efficiency of positive pressure ventilation (PPV)

  From time of insertion of PLMA till 120-minutes intraoperatively

• Postoperative sore throat

  From end of surgery till 24 hours postoperatively

• Postoperative cough

  From end of surgery till 24 hours postoperatively

• Postoperative difficulty in swallowing

  From end of surgery till 24 hours postoperatively

• Postoperative difficulty in speaking

  From end of surgery till 24 hours postoperatively

Study Arms (2)

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.

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.

Device: PLMA without introducer

Interventions

PLMA with introducer DEVICE

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 with Introducer'

PLMA without introducer DEVICE

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

PLMA without Introducer

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sir Ganga Ram Hospital: lead

Study Sites (1)

Nitin Sethi

New Delhi, National Capital Territory of Delhi, 110060, India

Location

MeSH Terms

Conditions

Airway Remodeling

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Rakesh Saxena, MBBS, MD

  Sir Ganga Ram Hospital, New Delhi, INDIA

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will be blinded to the study intervention as designated by the randomized group he/she would be allocated to. The investigator however will not be blinded to the group allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: 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.

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: March 3, 2021
• Primary Completion: March 16, 2022
• Study Completion: March 16, 2022
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)