Inflammatory Effects of a Lung Recruitment Manoeuvre

Not Applicable

• Conditions: Respiratory Insufficiency; Respiratory Distress Syndrome, Adult
• Interventions: Procedure: 40/30 recruitment manoeuvre; Device: continuous positive airway pressure (CPAP)

• Registration Number: NCT01070654
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

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.

Study Timeline

• Status Verified: 2010-02
• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-18
• Study Start: 2010-06
• Last Update Submitted: 2010-07-06
• Last Update Posted: 2010-07-07
• Primary Completion: 2010-10
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
40/30 Recruitment Manoeuvre	continuous positive airway pressure (CPAP)	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
40/30 Recruitment Manoeuvre	40/30 recruitment manoeuvre	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

Primary Outcome Measures

Name	Time	Method
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)
Echographic score of lung aeration	T0 (baseline), T2 (1 hr), T4 (3 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)
Chest X-Ray	T6 (24 hrs)

Secondary Outcome Measures

Name	Time	Method
Levels of IL-1, IL6, IL-8, IL-19, TNFa in the bronchoalveolar lavage	T0 (baseline), T4 (3 hrs)

Trial Locations

Locations (1)

U.O. Anestesia e Rianimazione IV, Azienda Ospedaliero Universitaria Pisana; 🇮🇹 Pisa, Italy