Effects of Secretion Removal in Ventilated Patients

Acute Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03758547
• Other study ID #: Stefano Nava
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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Arterial blood gas specimens will be withdrawn from the radial artery and analyzed with a blood gas analyzer The patients will be studied in the semi recumbent position.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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

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