Effects of Secretion Removal in Ventilated Patients

NCT03758547 | Unknown DMC

• 1 other identifier: Stefano Nava
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study the investigators will assess the effects of secretion removal on "noninvasive" respiratory mechanics, in deeply sedated mechanically ventilated patients All the mechanically ventilated patients will be submitted to the recording of compliance and resistance at baseline (time0), immediately after the application of 10 cycles alternating 30 cmH20 during expiration and -30 cmH20 during exhalation (time1). Afterward the patients will undergo an additional trail using the so called "percussion" technique, to assess any synergic effect of this procedure (time2)

Conditions

Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Changes in passive respiratory mechanics

  RESPIRATORY MECHANICS is monitored using the end-expiratory and end inspiratory technique, obtained pressing the hold command on the ventilator

  immediate

Secondary Outcomes (1)

• changes in arterial blood gases

  immediate

Study Arms (1)

in-exufflator and percussion technique

EXPERIMENTAL

assess the physiological effects, of a "common" daily practice of secretion removal in intubated patients, that are: in-exufflator technique and percussion technique

Device: in-exufflator technique; Device: percussion technique

Interventions

in-exufflator technique DEVICE

application through a device of 10 cycles using positive pressure (30 cmH20) during inspiration and negative pressure (-30 cmH20) during exhalation

in-exufflator and percussion technique

percussion technique DEVICE

sliding venturi system (phasitron), powered by compressed gas that can be changed from 0.8 up to 3.5 bar and that generates the oscillations in the range of 80-650 cycles/min

in-exufflator and percussion technique

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• consecutive ventilated and intubated patients
• age\> 18 yrs
• Sign inform consent
• clinical indication for secretion removal from the endotracheal tube

You may not qualify if:

• tracheotomy
• bullous emphysema
• pneumothorax

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• Fondazione Salvatore Maugeri: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Masking Details: patients deeply sedated and therefore not conscious
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Respiratory and Critical Care unit

Model Details: baseline (time0) application of 10 cycles of positive inspiratory and negative expiratory pressures (time1) application of percussion (time2)

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: November 29, 2018
• Study Start: January 1, 2019
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: November 29, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share