Inflammatory Effects of a Lung Recruitment Manoeuvre

Respiratory Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01070654
• Other study ID #: RM0910
• Secondary ID: RMSGMFF
• Status: Recruiting
• Phase: N/A
• First received: February 16, 2010
• Last updated: July 6, 2010
• Start date: June 2010
• Est. completion date: December 2010

Study information

• Verified date: February 2010
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: Francesco Forfori
• Phone: +39050993234
• Email: forforiden[@]libero.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Pulmonary Valve Insufficiency
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

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.

Device:
• continuous positive airway pressure (CPAP)
continuous positive airway pressure (CPAP)

Locations

Country	Name	City	State
Italy	U.O. Anestesia e Rianimazione IV, Azienda Ospedaliero Universitaria Pisana	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa		T0 (baseline), T4 (3 hrs), T5 (12 hrs)	No
Primary	Plasmatic concentration of Nitric Oxide		T0 (baseline), T6 (24 hrs)	No
Primary	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)	No
Primary	Echographic score of lung aeration		T0 (baseline), T2 (1 hr), T4 (3 hrs)	No
Primary	Chest X-Ray		T6 (24 hrs)	Yes
Secondary	Levels of IL-1, IL6, IL-8, IL-19, TNFa in the bronchoalveolar lavage		T0 (baseline), T4 (3 hrs)	No