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Clinical Trials/NCT05125744
NCT05125744
Unknown
Not Applicable

Effect of Positive End Expiratory Pressure on Respiratory Muscles Activity Assessed Through Ultrasound in Intubated Patient Undergoing Assisted Ventilation

Azienda Ospedaliera di Perugia1 site in 1 country30 target enrollmentMarch 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Assisted Ventilation
Sponsor
Azienda Ospedaliera di Perugia
Enrollment
30
Locations
1
Primary Endpoint
Diaphragmatic thickening fraction
Last Updated
4 years ago

Overview

Brief Summary

The investigators aim to assess the effects of positive end-expiratory pressure (PEEP) on diaphragmatic activity evaluated through ultrasound in patients admitted to intensive care unit (ICU) for acute respiratory failure (ARF) assisted via invasive mechanical ventilation in assisted mode.

Detailed Description

All adult critically ill patients admitted to intensive care unit (ICU) and undergoing invasive mechanical ventilation (IMV) for more than 24 hours with diagnosis of acute respiratory failure (ARF) will be screened. The exclusion criteria will be : pregnancy, neuromuscular diseases, wounds or incision at the probe placement site, contraindications to diaphragmatic and abdominal wall unltrasound, contraindications to the placement of a specific nasogastric feeding tube (Electrical activity of the diaphragm catheter). In all enrolled patients ventilated in assisted mode, diaphragmatic activity will be evaluated through ultrasound and electrical activity of the diaphragm (primary end point) at stepwise decreasing of PEEP level. Also, the activity of remaining respiratory muscles will be assessed through sonography at the same levels of PEEP (secondary end point) Across all study phases, patients will be sedated to assure a Richmond sedation Agitation Scale (RASS) score between 0 and -1. The following data will be recorded for each positive end-expiratory pressure explored: dosage of sedative drugs, peripheral oxygen saturation (SpO2), inspired oxygen fraction (FiO2), inpiratory and expiratory tidal volume, respiratory rate, electrical activity of the diaphragm (Eadi) (optional data), lung aeration through ultrasound or electrical impedance tomography (optional), thickness of diaphragmatic, parasternal intercostal, external oblique, internal oblique and transversus abdominis, combined with the lung ultrasound score. Thickness is measured at both end-expiration and end-inspiration for each respiratory muscles, as indirect estimation of respiratory muscles effort, and calculated according to standard formula as follows: Thickening fraction (%) = (inspiratory thickness - expiratory thickness) / expiratory thickness \* 100. All ultrasonographic measurements will be performed bedside with patients in semi-recument position, only on the right side , using a portable ultrasound machine equipped with a linear (7.5 - 12.0 MHz) or convex (2.0 - 4.0 MHz) probe. The same protocol will be carried out in case of non invasive ventilation application after extubation, reducing PEEP and inspiratory support

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
August 31, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof Gianmaria Cammarota

Clinical Prophessor

Azienda Ospedaliera di Perugia

Eligibility Criteria

Inclusion Criteria

  • age \> 18 years
  • invasive mechanical ventilation \> 48 hours

Exclusion Criteria

  • pregnancy
  • neuromuscular disease
  • wounds or incision at the probe placement site.

Outcomes

Primary Outcomes

Diaphragmatic thickening fraction

Time Frame: 20 minutes

The fraction of diaphragmatic thickness variations expressed in percentage during a stepwise decrease in positive end-expiratory pressure (PEEP)

Secondary Outcomes

  • Lung aeration(20 minutes)
  • Respiratory rate(20 minutes)
  • Electrical activity of the diaphragm (optional)(20 minutes)
  • Inspired oxygen fraction(20 minutes)
  • Peripheral oxygen saturation(20 minutes)
  • Expiratory Tidal volume(20 minutes)
  • Accessory respiratory muscles thickening fraction(20 minutes)

Study Sites (1)

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