Criteria Analysis for Ventilatory Support Adjustment of Mechanical Ventilation

January 18, 2017 updated by: University of Sao Paulo General Hospital
The indications for mechanical ventilation (MV) include excessive work of breathing, with or without evidence of respiratory muscle fatigue. The setting of the MV is still a challenge because it is based on criteria understudied, often subjective and observer-dependent. Despite several studies, to our knowledge has never been done before is the precise definition of the optimal range of ventilatory support. Novel and recognizable diagnostic techniques will be applied. No single parameter of the breathing pattern has good accuracy for the adjustment of ventilatory support. Non-invasive measures such as P0.1 and rate of muscle relaxation may have good accuracy for the adjustment of ventilatory support.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Use of excessive pressure support

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-000
        • Hospital Clinicas Sao Paulo
    • SP
      • Sao Paulo, SP, Brazil, 05403900
        • Hearth Institute - University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients under invasive mechanical ventilation for 48h
  • patients without the objective of complete rest of the respiratory muscles. This decision will be on the discretion of the attending physician,
  • spontaneous breathing,
  • clinically stability.

Exclusion Criteria:

  • Previous disease of the central nervous system that can lead to respiratory changes.
  • Previous disease of the peripheral nervous system that can lead to respiratory changes
  • Previous muscular disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Pressure Support Titration
The analysis of the diagnostic accuracy of the breathing pattern variables, P 0.1 and the rate of tracheal muscle relaxation.
Procedure: Variation of the level of pressure support during the mechanical ventilation
The pressure support of the patient was changed form the baseline to 20 cmH20 and then stepwise decreased to 2 cmH20,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring muscular force
Time Frame: From the baseline ventilation to the minimum level of pressure support. Around 3 hours
Muscular force measured by inspiratory force in centimeters of water (cmH2O)
From the baseline ventilation to the minimum level of pressure support. Around 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring inspiratory drive
Time Frame: From the baseline ventilation to the minimum level of pressure support. Around 3 hours
Inspiratory drive measured in cmH2O in the first 100 milliseconds of the inspiration
From the baseline ventilation to the minimum level of pressure support. Around 3 hours
Measuring endurance
Time Frame: From the baseline ventilation to the minimum level of pressure support. Around 3 hours
Endurance measured by the maximal relaxation rate (cmH2O/10ms)
From the baseline ventilation to the minimum level of pressure support. Around 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Study Director: Carlos Carvalho, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tematicomusculoUTI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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