Effect of Positive End Expiratory Pressure on Diaphragmatic Fraction Assessed Through Ultrasound in Intubated Patient Undergoing Assisted Ventilation

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diaphragm Injury; Positive End-expiratory Pressure; Assisted Ventilation
• Intervention / Treatment: Diagnostic test: Assisted Ventilation

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

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Gianmaria Cammarota; Phone Number: 039755783594; Email: gianmaria.cammarota@unipg.it

Study Locations

• Italy
  • Umbria, Italy
    • Perugia, Umbria, Italy, Italy, 06156
      • Università degli Studi di Perugia
      • Contact: Gianmaria Cammarota; Phone Number: 039755783594; Email: gianmaria.cammarota@unipg.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All adult patient admitted in intensive care unit for hypoxemic acute respiratory failure, undergoing invasive mechanical ventilation for more than 48 hours and, after this time, ventilated in Assisted Ventilation, i.e., pressure support ventilation (PSV)

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaphragmatic thickening fraction	The fraction of diaphragmatic thickness variations expressed in percentage during a stepwise decrease in positive end-expiratory pressure (PEEP)	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung aeration	Lung ultrasound score during a stepwise decrease in positive end-expiratory pressure (PEEP)	20 minutes
Peripheral oxygen saturation	Reflects the grade of peripheral oxygenation expressed in percentage during a stepwise decrease in positive end-expiratory pressure (PEEP)	20 minutes
Electrical activity of the diaphragm (optional)	reflects the electrical activity of the diaphragm expressed in microvolts during a stepwise decrease in positive end-expiratory pressure (PEEP)	20 minutes
Inspired oxygen fraction	inspired oxygen fraction during a stepwise decrease in positive end-expiratory pressure (PEEP)	20 minutes
Expiratory Tidal volume	Expiratory Tidal volume expressed in milliliters during a stepwise decrease in positive end-expiratory pressure (PEEP)	20 minutes
Respiratory rate	Respiratory rate during expressed in breaths on minute ratio during a stepwise decrease in positive end-expiratory pressure (PEEP)	20 minutes
Accessory respiratory muscles thickening fraction	The fractions of accessory respiratory muscles thickening fraction expressed in percentage during a stepwise decrease in positive end-expiratory pressure (PEEP)	20 minutes

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera di Perugia

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: October 23, 2021
• First Submitted That Met QC Criteria: November 7, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: February 26, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 4106/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: single patients data on motivated request to principal investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No