Criteria Analysis for Ventilatory Support Adjustment of Mechanical Ventilation

Not Applicable

Completed

• Conditions: Acute Mechanical Ventilatory Failure
• Interventions: Procedure: Variation of the level of pressure support during the mechanical ventilation

• Registration Number: NCT02743624
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Detailed Description

Use of excessive pressure support

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-18
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-19
• Status Verified: 2016-08
• Primary Completion: 2016-11
• Study Completion: 2016-12
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pressure Support Titration	Variation of the level of pressure support during the mechanical ventilation	The analysis of the diagnostic accuracy of the breathing pattern variables, P 0.1 and the rate of tracheal muscle relaxation.

Primary Outcome Measures

Name	Time	Method
Measuring muscular force	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)

Secondary Outcome Measures

Name	Time	Method
Measuring inspiratory drive	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
Measuring endurance	From the baseline ventilation to the minimum level of pressure support. Around 3 hours	Endurance measured by the maximal relaxation rate (cmH2O/10ms)

Trial Locations

Locations (2)

Hospital Clinicas Sao Paulo; 🇧🇷 Sao Paulo, Brazil

Hearth Institute - University of Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil