Criteria Analysis for Ventilatory Support Adjustment of Mechanical Ventilation

Acute Mechanical Ventilatory Failure Clinical Trial

Official title:

Criteria Analysis for Ventilatory Support Adjustment of Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02743624
• Other study ID #: tematicomusculoUTI
• Status: Completed
• Phase: N/A
• First received: March 18, 2016
• Last updated: January 18, 2017
• Start date: February 2016
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Use of excessive pressure support

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Mechanical Ventilatory Failure
• Hypoventilation

Intervention

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,

Locations

Country	Name	City	State
Brazil	Hearth Institute - University of Sao Paulo	Sao Paulo	SP
Brazil	Hospital Clinicas Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measuring inspiratory drive	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
Secondary	Measuring endurance	Endurance measured by the maximal relaxation rate (cmH2O/10ms)	From the baseline ventilation to the minimum level of pressure support. Around 3 hours