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Completed

NCT Number: NCT02743624

Criteria Analysis for Ventilatory Support Adjustment of Mechanical Ventilation

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hearth Institute - University of Sao Paulo, São Paulo, Brazil

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About this study

Use of excessive pressure support

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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,

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 19, 2016
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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