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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05125744
Other study ID # 4106/19
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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