Inflammatory Effects of a Lung Recruitment Manoeuvre

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective, Open, Uncontrolled, Non-randomized and Monocentric Trial on the Efficacy and the Inflammatory Effects of a Lung Recruitment Manoeuvre in Mechanical Ventilated Patients With Respiratory Failure

Conditions
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Respiratory Insufficiency, Respiratory Distress Syndrome, Adult

Intervention / Treatment
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* Procedure: 40/30 recruitment manoeuvre
* Device: continuous positive airway pressure (CPAP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mechanical Ventilation Arterial catheter inserted Hypoxemic respiratory failure (Pa02/FiO2 <300) Radiological evidence of atelectasis or pulmonary infiltrates in the CXR Informed consent Exclusion Criteria: Elevated intracranial pressure >25 mmHg Bronchopulmonary fistula Emphysema Kidney or Liver failure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 40/30 Recruitment Manoeuvre<br>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 | Procedure: 40/30 recruitment manoeuvre<br>* 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.<br>* Other names: PEEP;Device: continuous positive airway pressure (CPAP)<br>* continuous positive airway pressure (CPAP)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of IL-1, IL6, IL-8, IL-19, TNFa in the bronchoalveolar lavage |  | T0 (baseline), T4 (3 hrs) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARDS, Recruitment Manoeuvres, PEEP, Cytokines, Respiratory Insufficiency