Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03758547
Other study ID # Stefano Nava
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date June 30, 2019

Study information

Verified date November 2018
Source Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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Arterial blood gas specimens will be withdrawn from the radial artery and analyzed with a blood gas analyzer The patients will be studied in the semi recumbent position.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)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date June 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi Fondazione Salvatore Maugeri

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 immediate
See also
  Status Clinical Trial Phase
Recruiting NCT05144633 - Blue Protocol and Eko Artificial Intelligence Are Best (BEA-BEST)
Completed NCT04534569 - Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF)
Recruiting NCT03021902 - Nutrition and Exercise in Critical Illness Phase 2
Completed NCT02902146 - Bougie Use in Emergency Airway Management N/A
Completed NCT02901158 - Esophageal Manometry in Mechanically Ventilated Patients
Completed NCT02236559 - High Flow Therapy for the Treatment of Respiratory Failure in the ED N/A
Recruiting NCT02056093 - Comparison of Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist N/A
Terminated NCT01083277 - Variable Ventilation During Acute Respiratory Failure N/A
Not yet recruiting NCT01668368 - Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance N/A
Completed NCT01462279 - Effect of Thiamine on Oxygen Utilization (VO2) in Critical Illness N/A
Completed NCT01114022 - Prevention Inhalation of Bacterial by Using Endotracheal Tube Balloon Polyvinyl Chloride or Polyurethane N/A
Active, not recruiting NCT01058421 - Treatment of Critical Illness Polyneuromyopathy Phase 2
Completed NCT00252616 - Timing of Target Enteral Feeding in the Mechanically Ventilated Patient Phase 2/Phase 3
Recruiting NCT04098094 - Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases
Recruiting NCT06051292 - Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement N/A
Completed NCT04601090 - Survival Rates and Longterm Outcomes After COVID-19
Recruiting NCT05423301 - Global Physiotherapy in ICU Patients With High Risk Extubation Failure N/A
Completed NCT02447692 - Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: The PROMIZING Study N/A
Completed NCT04016480 - HFNC During Bronchoscopy for Bronchoalveolar Lavage N/A
Completed NCT04507425 - High Flow Nasal Cannula With Noninvasive Ventilation N/A