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

NCT05116839 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-11-19

No results posted yet for this study

Summary

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 .

Conditions

  • Ventilator Lung

Interventions

DEVICE

the first 15 minutes with pressure support ventilation

PSV pressure support ventilation:triggered by minute volume \< 3 Liter ,with no frequency

DEVICE

the following 15 minutes ventilation will be changed to continous positive air way pressureCPAP mode

continous positive air way pressure CPAP mode at 10 cm H2o .

DEVICE

i gel air way

supraglottic air way device

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Golnar Se Hammouda, M.D · Professor of Anesthesia Intensive Care Faculty of Medicine - Mansoura University

  • Hanaa Ma El-Bendary, M.D · Assistant Professor of Anesthesia Intensive Care Faculty of Medicine - Mansoura University

  • Marwa Ib Abdo, M.D · Lecturer of Anesthesia Intensive Care Faculty of Medicine - Mansoura University

  • Bahaa Mo Ezz, MBBCh · Resident of Anesthesia Intensive Care Mansoura University Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-31
Primary Completion
2021-12-28
Completion
2022-10-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05116839 on ClinicalTrials.gov