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| ID | Type | Description | Link |
|---|---|---|---|
| RMSGMFF | Other Identifier | IV Anestesia e Rianimazione |
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Recruitment manoeuvres, consisting of sustained inflations at high airway pressures, have been advocated as an adjunct to mechanical ventilation in lung protective ventilation strategies to prevent the collapse of the lung.
This study aims to determine the safety and efficacy of a recruitment manoeuvre, by considering its impact on gas exchange, hemodynamics and on the release of systemic inflammatory mediators.
This prospective study will analyse the effects of a single recruitment manoeuvre in critically ill patients. Subjects will be mechanically ventilated patients needing alveolar RMs. After a period of stable lung protective approach ventilation, they will receive the "40/30" RM; lung mechanics, gas exchange, hemodynamics and plasmatic concentration of inflammatory mediators will be obtained before and after the RM. An ultrasound score, established from the lung aeration status of upper and lower parts of anterior and lateral chest wall, will also be calculated before and after the manoeuvre.In selected patients cytokine release in the bronchoalveolar lavage will be measured as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 40/30 Recruitment Manoeuvre | Experimental | Patients with respiratory failure that will be first ventilated for 30 minutes according to standardized baseline protective ventilation and after that will receive the recruitment manoeuvre |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 40/30 recruitment manoeuvre | Procedure | The ventilator will be switched to the continuous positive airway pressure (CPAP) mode and the pressure will be increased to 40 cmH20 for 30 seconds. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa | T0 (baseline), T4 (3 hrs), T5 (12 hrs) | |
| Plasmatic concentration of Nitric Oxide | T0 (baseline), T6 (24 hrs) | |
| Lung mechanics (Peak pressure, Mean pressure, Compliance, Resistance) Gas exchange (pH, PaO2, PaCO2, HCO3-, SaO2, PaO2/FiO2) Haemodynamics (Mean arterial pressure, Heart rate) | T0 (baseline), T1 (30 secs), T2 (1 hr), T3 (2 hrs) | |
| Echographic score of lung aeration | T0 (baseline), T2 (1 hr), T4 (3 hrs) | |
| Chest X-Ray | T6 (24 hrs) |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of IL-1, IL6, IL-8, IL-19, TNFa in the bronchoalveolar lavage | T0 (baseline), T4 (3 hrs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Forfori | Contact | +39050993234 | forforiden@libero.it | |
| Giuseppe Mancino | Contact | +393471216535 | giumancino@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Forfori | UO IV Anestesia e Rianimazione | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.O. Anestesia e Rianimazione IV, Azienda Ospedaliero Universitaria Pisana | Recruiting | Pisa | Pisa | 56126 | Italy |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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|
| continuous positive airway pressure (CPAP) | Device | continuous positive airway pressure (CPAP) |
|
| D012138 |
| Respiratory Therapy |