Inflammatory Effects of a Lung Recruitment Manoeuvre

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pisa, Italy, 56126
    • Recruiting
    • U.O. Anestesia e Rianimazione IV, Azienda Ospedaliero Universitaria Pisana
    • Contact: Francesco Forfori; Phone Number: +39050993234; Email: forforiden@libero.it
    • Sub-Investigator: Giuseppe Mancino
    • Principal Investigator: Francesco Forfori
    • Principal Investigator: Antonio Abramo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: 40/30 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.; Other Names: PEEP; Recruitment Manoeuvres; ARDS open lung strategy; Device: continuous positive airway pressure (CPAP); continuous positive airway pressure (CPAP)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero, Universitaria Pisana
• Investigators: Principal Investigator: Francesco Forfori, UO IV Anestesia e Rianimazione

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): October 1, 2010
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: February 16, 2010
• First Submitted That Met QC Criteria: February 17, 2010
• First Posted (Estimate): February 18, 2010

Study Record Updates

• Last Update Posted (Estimate): July 7, 2010
• Last Update Submitted That Met QC Criteria: July 6, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: ARDS; Cytokines; Respiratory Insufficiency; PEEP; Recruitment Manoeuvres
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: RM0910; RMSGMFF (Other Identifier: IV Anestesia e Rianimazione)