NCT05116839

Pressure Support Ventilation Versus Continuous Positive Air Way Pressure (CPAP) Using I Gelin Adult Patients,

Status unknown NA Last updated 19 November 2021

What this trial tests

NA trial testing the first 15 minutes with pressure support ventilation in Ventilator Lung in 38 participants. Status unknown.

Timeline

31 March 2019

Primary endpoint
28 December 2021

15 October 2022

Quick facts

Lead sponsor	Mansoura University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	other
Enrollment	38
Start date	31 March 2019
Primary completion	28 December 2021
Estimated completion	15 October 2022
Sites	1 location across Egypt

Drugs / interventions tested

• the first 15 minutes with pressure support ventilation
• the following 15 minutes ventilation will be changed to continous positive air way pressureCPAP mode
• i gel air way

Conditions studied

• Ventilator Lung — all drugs for Ventilator Lung →

Sponsor

Mansoura University

Who can join

Adults 18 to 65, any sex, with Ventilator Lung. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction of Supra glottic airway devices (SAD) has revolutionized the airway management. The first successful supraglottic airway device, the Laryngeal Mask Airway(LMA).The various other SADs include ProSeal LMA, Intubating LMA and i-gel to overcome the limitations of classic Laryngeal Mask Airway( c-LMA) The risk of aspiration with c-LMA is reported tobe around 9% , pleaseboth the c-LMA and PLMA have cuff related complications. High cuff pressure in laryngeal mask airways can cause damage to the mucosae on periglottic and supraglottic structures .

Therefore, to overcome the limitations of Pro Seal Laryngeal Mask Airway (PLMA )a new and cheaper SAD called i-gel was developed. i-gel is a novel and innovative, latex free supraglottic device, made up of medical grade thermoplastic elastomer, which is soft, gel like, transparent The number of manipulations required are more in PLMA than i gel resulting in hemodynamic changes .The i-gel is comparable to PLMA insuring the airway during controlled ventilation. It is better than PLMA in terms of ease of insertion.

Spontaneous breathing is the most popular mode of ventilation with the laryngeal mask airway (LMA), but it provides less effective gas exchange than does positive pressure ventilation (PPV) . The patients receiving sevoflurane anesthesia with unassisted ventilation have a reduced rib cage contribution to ventilation, decreased tidal volume, and respiratory rate .

Pressure support ventilation (PSV) is a ventilator mode that is initiated by the patient and synchronized with the patient's respiratory effort. And may improve gaseous exchange in patients. In the intensive care unit, it is often considered the preferred mode for weaning mechanical ventilation .PSV provides more effective gas exchange than does unassisted ventilation with CPAP during anesthesia with the LMA while preserving hemodynamic homeostasis.

The use of PSV versus CPAP with the Pro Seal laryngeal mask airway in anesthetized pediatric patients revealed that PSV improved gaseous exchange and reduced work of breathing during general anesthesia PSV via Pro- Seal laryngeal mask airway improves gaseous exchange and ventilation in pediatric patients under general anesthesia more than spontaneous ventilation .

Publications & conference data

No peer-reviewed publications indexed yet for this trial.