Clinical trial NCT01070654: Inflammatory Effects of a Lung Recruitment Manoeuvre
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Keywords: ARDS
Recruitment Manoeuvres
PEEP
Cytokines
Respiratory Insufficiency
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2010-02-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa
timeFrame: T0 (baseline), T4 (3 hrs), T5 (12 hrs)
measure: Plasmatic concentration of Nitric Oxide
timeFrame: T0 (baseline), T6 (24 hrs)
measure: Lung mechanics (Peak pressure, Mean pressure, Compliance, Resistance) Gas exchange (pH, PaO2, PaCO2, HCO3-, SaO2, PaO2/FiO2) Haemodynamics (Mean arterial pressure, Heart rate)
timeFrame: T0 (baseline), T1 (30 secs), T2 (1 hr), T3 (2 hrs)
measure: Echographic score of lung aeration
timeFrame: T0 (baseline), T2 (1 hr), T4 (3 hrs)
measure: Chest X-Ray
timeFrame: T6 (24 hrs)
Secondary outcomes:
measure: Levels of IL-1, IL6, IL-8, IL-19, TNFa in the bronchoalveolar lavage
timeFrame: T0 (baseline), T4 (3 hrs)
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: U.O. Anestesia e Rianimazione IV, Azienda Ospedaliero Universitaria Pisana
Study officials:
affiliation: UO IV Anestesia e Rianimazione
name: Francesco Forfori
role: PRINCIPAL_INVESTIGATOR
References: