Criteria Analysis for Ventilatory Support Adjustment of Mechanical Ventilation

NCT02743624 | Completed DMC

• 1 other identifier: tematicomusculoUTI
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Acute Mechanical Ventilatory Failure

Outcome Measures

Primary Outcomes (1)

• Measuring muscular force

  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 Outcomes (2)

• Measuring inspiratory drive

  From the baseline ventilation to the minimum level of pressure support. Around 3 hours

• Measuring endurance

  From the baseline ventilation to the minimum level of pressure support. Around 3 hours

Study Arms (1)

Pressure Support Titration

OTHER

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

Interventions

Variation of the level of pressure support during the mechanical ventilation PROCEDURE

The pressure support of the patient was changed form the baseline to 20 cmH20 and then stepwise decreased to 2 cmH20,

Pressure Support Titration

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (2)

Hospital Clinicas Sao Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

Hearth Institute - University of Sao Paulo

São Paulo, São Paulo, 05403900, Brazil

Location

Study Officials

• Carlos Carvalho

  University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: April 19, 2016
• Study Start: February 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 19, 2017

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)