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Effects of Secretion Removal in Ventilated Patients

Physiological Effects of the Application of Secretion Removal Device in Invasively Ventilated Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03758547
Enrollment
20
Registered
2018-11-29
Start date
2019-01-01
Completion date
2019-06-30
Last updated
2018-11-29

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

Conditions

Acute Respiratory Failure

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)

Detailed description

In this observational study, the investigators will assess the effects of two secretion removal techniques on passive respiratory mechanics, in patients undergoing invasive mechanical ventilation. Consecutive patients will undergo 3 sequential assessments at time0 (baseline), at time1 after the application of of 10 cycles alternating 30 cmH20 during expiration and -30 cmH20 during exhalation and finally after a 20 sec application of a percussion technique. Protocol: The patients will be ventilated without PEEP and sedated with a benzodiazepine infusion to produce complete relaxation and adaptation to the ventilator, as assessed by the complete absence of spontaneous efforts, so that there was no change in inspiratory flow rate, tidal volume, or respiratory rate during the three measurement periods. Airway pressure (Paw) and flow (V) will be measured continuously throughout the respiratory cycle with the transducer and expiratory tidal volume will obtained by electrical integration of the flow signal. Arterial blood gas specimens will be withdrawn from the radial artery and analyzed with a blood gas analyzer The patients will be studied in the semi recumbent position. After baseline measurements of respiratory mechanics will recorded under control conditions. Direct measurement of PEEPi will be obtained using the following method: After several breaths under controlled mechanical ventilation, and with the patient relaxed, the airway opening is occluded at the end of a tidal expiration, using the end-expiratory hold button incorporated in the ventilator. The occlusion will be then released for the mechanical lung inflation, and after a few breaths the airway opening will be again occluded at the end of the inflation, using the end-inspiratory hold button of the ventilator. The static compliance of the total respiratory system (Cst rs) will be corrected for the compliance of the ventilator tubing and the gas compression (0.8 ml/cm H20 2). The end-inspiratory occlusion technique also allows determination of the inspiratory resistive properties of the respiratory system, named R,rs min and R,rsmax, that means the minimal respiratory resistances (those due mainly to the airways) and maximal respiratory resistances (those mainly due to stress relaxation and Pendelluft)

Interventions

DEVICEin-exufflator technique

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

DEVICEpercussion technique

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

Sponsors

Fondazione Salvatore Maugeri
CollaboratorOTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Masking description

patients deeply sedated and therefore not conscious

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

consecutive ventilated and intubated patients 1. age\> 18 yrs 2. Sign inform consent 3. clinical indication for secretion removal from the endotracheal tube \-

Exclusion criteria

* tracheotomy * bullous emphysema * pneumothorax

Design outcomes

Primary

MeasureTime frameDescription
Changes in passive respiratory mechanicsimmediateRESPIRATORY MECHANICS is monitored using the end-expiratory and end inspiratory technique, obtained pressing the hold command on the ventilator

Secondary

MeasureTime frameDescription
changes in arterial blood gasesimmediatechanges in arterial partial oxygen tension and in arterial partial carbon dioxide tension obtained with a puncture of the radial artery

Outcome results

None listed

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