Conventional Versus Automated Bag-based Mechanical Ventilator to Support ARDS Patients

NCT06667375 | Completed

• 1 other identifier: 002-2021-CEICVyTech/PUCP
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the extubation success and compares the survival rate in patients with signs of Covid-19 intubated with Masi, a novel type of mechanical ventilator, or with other conventional ventilators admitted in the ICU of a reference hospital in Lima, Peru between January and August 2021. The Masi mechanical ventilator works by automating a resuscitation bag with promising preclinical results. The key features of Masi are its low manufacturing cost, low dependence on a supply of high volumes of oxygen, low oxygen consumption, flexibility between non-invasive and invasive ventilation, and extended range of working environmental altitudes compared to commercially available ventilators. A retrospective study of variables and outcomes was done. The main goal of this study is to compare the survival rate of respiratory failure patients supported either with Masi or conventional ventilators at Hospital Vitarte II in Lima between January and August 2021.

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Keywords

Ventilators; Medical devices,; Data analysis; Technological innovation

Outcome Measures

Primary Outcomes (1)

• ICU discharge status

  After being in the ventilator in the ICU what happened at extubation or censoring time.

  Patients were followed 15 days (median)

Secondary Outcomes (5)

• Ventilator parameter: Oxygen Saturation (%)

  Patients were followed up 15 days (median)

• Ventilator parameter: Respiratory rate (breaths/minute)

  Patients were followed up 15 days (median)

• Ventilator parameter: PaO2/FiO2 ratio

  Patients were followed up 15 days (median)

• Ventilator parameters: Tidal volumen (mL)

  Patients were followed up 15 days (median)

• Ventilator parameters: PIP (mmHg)

  Patients were followed up 15 days (median)

Study Arms (2)

Masi

Patients who were diagnosed with Covid-19, with signs of Acute Respiratory Distress Syndrome (ARDS), intubated, and connected to an automated-bag mechanical ventilator in the ICU

Conventional

Patients who were diagnosed with Covid-19, with signs of Acute Respiratory Distress Syndrome (ARDS), intubated, and connected to a commercial mechanical ventilator in the ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data from patients that were diagnosed with Covid-19, intubated and connected to a mechanical ventilator in the ICU between January 19, 2021 to August 27, 2021 which coincides with the second Peruvian wave of the Covid-19 pandemics in the Hospital Vitarte II in Lima

You may qualify if:

• Patients hospitalized to ICU requiring mechanical ventilation during COVID-19 pandemic
• Over 18 years old

You may not qualify if:

• \- None

Sponsors & Collaborators

• Fanny Lys Casado Pena: lead
• EsSalud Hospital Vitarte (HOSPITAL II VITARTE ESSALUD): collaborator

Study Sites (1)

Pontificia Universidad Católica del Perú

Lima, 15023, Peru

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Fanny L Casado Peña, PhD

  Pontificia Universidad Catolica del Peru

  PRINCIPAL INVESTIGATOR

• Sergio Sánchez-Gambetta, MD, MSc

  Pontificia Universidad Catolica del Peru

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 31, 2024
• Study Start: January 19, 2021
• Primary Completion: August 27, 2021
• Study Completion: December 20, 2022
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

PE (1)