Respiratory Distress Syndrome, Adult, Respiratory Insufficiency
Conditions
Keywords
ARDS, Recruitment Manoeuvres, PEEP, Cytokines, Respiratory Insufficiency
Brief summary
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
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.
Interventions
PROCEDURE40/30 recruitment manoeuvre
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.
DEVICEcontinuous positive airway pressure (CPAP)
continuous positive airway pressure (CPAP)
Sponsors
Azienda Ospedaliero, Universitaria Pisana
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Levels of IL-1, IL6, IL-8, IL-19, TNFa in the bronchoalveolar lavage | T0 (baseline), T4 (3 hrs) |
Countries
Italy
Contacts
Primary ContactFrancesco Forfori
Backup ContactGiuseppe Mancino
Outcome results
None listed