Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
20 participants
INTERVENTIONAL
2019-01-01
2019-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effects of Mechanical Insufflation-exsufflation on Airway Mucus Clearance in the ICU
NCT03178565
Noninvasive Ventilation Therapy for the Treatment of Pleural Effusion in Patients With Heart Failure
NCT03189654
Non Invasive Mechanical Ventilation in Chronic Respiratory Insufficiency Patients During Rehabilitation
NCT01458314
Inflammatory Effects of a Lung Recruitment Manoeuvre
NCT01070654
Effects of Different Assisted Mechanical Ventilation in Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) Patients
NCT00267241
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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Arterial blood gas specimens will be withdrawn from the radial artery and analyzed with a blood gas analyzer The patients will be studied in the semi recumbent position.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)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
in-exufflator and percussion technique
assess the physiological effects, of a "common" daily practice of secretion removal in intubated patients, that are: in-exufflator technique and percussion technique
in-exufflator technique
application through a device of 10 cycles using positive pressure (30 cmH20) during inspiration and negative pressure (-30 cmH20) during exhalation
percussion 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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
in-exufflator technique
application through a device of 10 cycles using positive pressure (30 cmH20) during inspiration and negative pressure (-30 cmH20) during exhalation
percussion 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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. age\> 18 yrs
2. Sign inform consent
3. clinical indication for secretion removal from the endotracheal tube
\-
Exclusion Criteria
* bullous emphysema
* pneumothorax
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondazione Salvatore Maugeri
OTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
dr. Stefano Nava
Chief of Respiratory and Critical Care unit
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Stefano Nava
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.