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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05125744
Enrollment
30
Registered
2021-11-18
Start date
2022-03-01
Completion date
2022-08-31
Last updated
2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Assisted Ventilation, Diaphragm Injury, Positive End-expiratory Pressure

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

Interventions

DIAGNOSTIC_TESTAssisted 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).

Sponsors

Azienda Ospedaliera di Perugia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Diaphragmatic thickening fraction20 minutesThe fraction of diaphragmatic thickness variations expressed in percentage during a stepwise decrease in positive end-expiratory pressure (PEEP)

Secondary

MeasureTime frameDescription
Peripheral oxygen saturation20 minutesReflects the grade of peripheral oxygenation expressed in percentage during a stepwise decrease in positive end-expiratory pressure (PEEP)
Electrical activity of the diaphragm (optional)20 minutesreflects the electrical activity of the diaphragm expressed in microvolts during a stepwise decrease in positive end-expiratory pressure (PEEP)
Inspired oxygen fraction20 minutesinspired oxygen fraction during a stepwise decrease in positive end-expiratory pressure (PEEP)
Lung aeration20 minutesLung ultrasound score during a stepwise decrease in positive end-expiratory pressure (PEEP)
Respiratory rate20 minutesRespiratory rate during expressed in breaths on minute ratio during a stepwise decrease in positive end-expiratory pressure (PEEP)
Accessory respiratory muscles thickening fraction20 minutesThe fractions of accessory respiratory muscles thickening fraction expressed in percentage during a stepwise decrease in positive end-expiratory pressure (PEEP)
Expiratory Tidal volume20 minutesExpiratory Tidal volume expressed in milliliters during a stepwise decrease in positive end-expiratory pressure (PEEP)

Countries

Italy

Contacts

Primary ContactGianmaria Cammarota
gianmaria.cammarota@unipg.it039755783594

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026