Effects of Secretion Removal in Ventilated Patients
Primary Purpose
Acute Respiratory Failure
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
in-exufflator technique
percussion technique
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Failure
Eligibility Criteria
Inclusion Criteria:
consecutive ventilated and intubated patients
- age> 18 yrs
- Sign inform consent
clinical indication for secretion removal from the endotracheal tube
-
Exclusion Criteria:
- tracheotomy
- bullous emphysema
- pneumothorax
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
in-exufflator and percussion technique
Arm Description
assess the physiological effects, of a "common" daily practice of secretion removal in intubated patients, that are: in-exufflator technique and percussion technique
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
changes in arterial blood gases
changes in arterial partial oxygen tension and in arterial partial carbon dioxide tension obtained with a puncture of the radial artery
Full Information
NCT ID
NCT03758547
First Posted
November 23, 2018
Last Updated
November 27, 2018
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators
Fondazione Salvatore Maugeri
1. Study Identification
Unique Protocol Identification Number
NCT03758547
Brief Title
Effects of Secretion Removal in Ventilated Patients
Official Title
Physiological Effects of the Application of Secretion Removal Device in Invasively Ventilated Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Anticipated)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators
Fondazione Salvatore Maugeri
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
baseline (time0) application of 10 cycles of positive inspiratory and negative expiratory pressures (time1) application of percussion (time2)
Masking
None (Open Label)
Masking Description
patients deeply sedated and therefore not conscious
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
in-exufflator and percussion technique
Arm Type
Experimental
Arm Description
assess the physiological effects, of a "common" daily practice of secretion removal in intubated patients, that are: in-exufflator technique and percussion technique
Intervention Type
Device
Intervention Name(s)
in-exufflator technique
Intervention Description
application through a device of 10 cycles using positive pressure (30 cmH20) during inspiration and negative pressure (-30 cmH20) during exhalation
Intervention Type
Device
Intervention Name(s)
percussion technique
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in passive respiratory mechanics
Description
RESPIRATORY MECHANICS is monitored using the end-expiratory and end inspiratory technique, obtained pressing the hold command on the ventilator
Time Frame
immediate
Secondary Outcome Measure Information:
Title
changes in arterial blood gases
Description
changes in arterial partial oxygen tension and in arterial partial carbon dioxide tension obtained with a puncture of the radial artery
Time Frame
immediate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
consecutive ventilated and intubated patients
age> 18 yrs
Sign inform consent
clinical indication for secretion removal from the endotracheal tube
-
Exclusion Criteria:
tracheotomy
bullous emphysema
pneumothorax
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
not allow to release individual data of the patients
Learn more about this trial
Effects of Secretion Removal in Ventilated Patients
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