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

Diaphragm Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05125744
• Other study ID #: 4106/19
• Status: Not yet recruiting
• Start date: March 1, 2022
• Est. completion date: August 31, 2022

Study information

• Verified date: February 2022
• Source: Azienda Ospedaliera di Perugia
• Contact: Gianmaria Cammarota
• Phone: 039755783594
• Email: gianmaria.cammarota[@]unipg.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• age > 18 years

• invasive mechanical ventilation > 48 hours

Exclusion Criteria:

• pregnancy

• neuromuscular disease

• wounds or incision at the probe placement site.

Related Conditions & MeSH terms

• Assisted Ventilation
• Diaphragm Injury
• Positive End-expiratory Pressure

Intervention

Diagnostic Test:
• Assisted Ventilation
patients will be invasively ventilated in assisted mode. In all enrolled patients ventilated in assisted mode. Diaphragmatic activity will be evaluated through ultrasound (primary end point) and electrical activity of the diaphragm (optional) 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).

Locations

Country	Name	City	State
Italy	Università degli Studi di Perugia	Perugia	Umbria, Italy

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Perugia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lung aeration	Lung ultrasound score during a stepwise decrease in positive end-expiratory pressure (PEEP)	20 minutes
Secondary	Peripheral oxygen saturation	Reflects the grade of peripheral oxygenation expressed in percentage during a stepwise decrease in positive end-expiratory pressure (PEEP)	20 minutes
Secondary	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
Secondary	Inspired oxygen fraction	inspired oxygen fraction during a stepwise decrease in positive end-expiratory pressure (PEEP)	20 minutes
Secondary	Expiratory Tidal volume	Expiratory Tidal volume expressed in milliliters during a stepwise decrease in positive end-expiratory pressure (PEEP)	20 minutes
Secondary	Respiratory rate	Respiratory rate during expressed in breaths on minute ratio during a stepwise decrease in positive end-expiratory pressure (PEEP)	20 minutes
Secondary	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