Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation

NCT04030208 | Completed DMC

• 1 other identifier: 1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, control crossover study comparing Umbulizer's efficacy to traditional mechanical ventilators

Conditions

Respiratory Failure; Respiratory Insufficiency; Respiratory Arrest

Keywords

respiratory disease; low resource settings; mechanical ventilation; ventilator performance; comparative study; patient safety; ease of use

Outcome Measures

Primary Outcomes (2)

• Partial Pressure of Carbon Dioxide (PaCO2)

  PaCO2 in mmHg at t = 1 hr (from Arterial Blood Gas or ABG readings) when patient is on Umbulizer compared to PaCO2 at t = 1 hr when patient is on a traditional mechanical ventilator

  2 hours

• pH

  pH at t = 1 hr (from ABG readings) when patient is on Umbulizer compared to pH at t = 1 hr when patient is on a traditional mechanical ventilator

  2 hours

Secondary Outcomes (1)

• Number of Adverse Events

  2 hours

Other Outcomes (4)

• Level of Comfort

  2 hours

• Ease of Use

  2 hours

• Partial Pressure of Oxygen (PaO2)

  2 hours

Study Arms (2)

Sequence A

OTHER

If patient is randomly assigned to Sequence A, they will be placed on a traditional ventilator for the first period. This period will be 1 hour in duration. Delivered tidal volume, respiratory rate (RR), and peak pressure will be recorded throughout the period using the ventilator. Heart rate (HR), Blood Pressure (BP), and oxygen (O2) saturation measurements will be recorded every 5 minutes. Arterial blood gas (ABG) data will be taken at t = 1 hour if the patient is stable on the traditional ventilator. ABGs may be taken more frequently if the patient is destabilizing. Next, the study participant will be transitioned to the Umbulizer to begin Period 2. This period will also be 1 hour in duration. Delivered tidal volume, RR, and peak pressure will be recorded throughout the period using Umbulizer. HR, BP, O2 saturation measurements will be taken every 5 minutes. ABG data will be taken at t = 30 minutes and 1 hour.

Device: Umbulizer; Device: Traditional Mechanical Ventilator

Sequence B

OTHER

If patient is randomly assigned to Sequence B, they will be shifted to the Umbulizer for the first period. This period will be 1 hour in duration. Delivered tidal volume, RR, and peak pressure will be recorded throughout the period using Umbulizer. HR, BP, O2 saturation measurements will be recorded every 5 minutes. ABG data will be taken at t = 30 minutes and 1 hour. Next, the study participant will be transitioned to a traditional ventilator to begin Period 2. This period will also be 1 hour in duration. Delivered tidal volume, RR, and peak pressure will be recorded throughout the period using the ventilator. HR, BP, O2 saturation measurements will be recorded every 5 minutes. ABG data will be taken at t = 1 hour if the patient is stable on the traditional ventilator. ABGs may be taken more frequently if the patient is destabilizing.

Device: Umbulizer; Device: Traditional Mechanical Ventilator

Interventions

Umbulizer DEVICE

Umbulizer is a reliable, user-friendly, and portable system that provides consistent air to the patient by quantitatively delivering a pre-determined tidal volume, inhale/exhale (I/E) ratio, peak pressure, and breathing rate (BPM). It can be configured to deliver either controlled ventilation or assist-controlled ventilation.

Sequence A; Sequence B

Traditional Mechanical Ventilator DEVICE

A medical device designed to artificially perform breathing functions for patients who are unable to adequately perform these functions on their own.

Sequence A; Sequence B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Patients needing mechanical ventilation

You may not qualify if:

• Patients with significant airway resistance (i.e. severe chronic obstructive pulmonary disease or asthma) where clinical investigator is concerned about gas trapping or barotrauma
• Patients with very low lung compliance (i.e. severe acute respiratory distress syndrome or restrictive disease) where clinical investigator is concerned about problems delivering sufficient tidal volume or end expiratory pressure
• Patients who experienced a myocardial infarction within the last 6 weeks
• Patients who are determined by a clinical investigator to be too hemodynamically unstable to be enrolled

Sponsors & Collaborators

• Umbulizer LLC: lead

Study Sites (1)

Services Hospital

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Apnea; Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kamran Chima, MBBS

  Services Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 23, 2019
• Study Start: September 4, 2018
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: August 6, 2020

Record last verified: 2020-08

Locations

PA (1)