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Inflammatory Effects of a Lung Recruitment Manoeuvre

Primary Purpose

Respiratory Insufficiency, Respiratory Distress Syndrome, Adult

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

40/30 recruitment manoeuvre

continuous positive airway pressure (CPAP)

About this trial

This is an interventional treatment trial for Respiratory Insufficiency focused on measuring ARDS, Recruitment Manoeuvres, PEEP, Cytokines, Respiratory Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

U.O. Anestesia e Rianimazione IV, Azienda Ospedaliero Universitaria PisanaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

40/30 Recruitment Manoeuvre

Arm Description

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

Outcomes

Primary Outcome Measures

Plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa

Plasmatic concentration of Nitric Oxide

Lung mechanics (Peak pressure, Mean pressure, Compliance, Resistance) Gas exchange (pH, PaO2, PaCO2, HCO3-, SaO2, PaO2/FiO2) Haemodynamics (Mean arterial pressure, Heart rate)

Echographic score of lung aeration

Chest X-Ray

Secondary Outcome Measures

Levels of IL-1, IL6, IL-8, IL-19, TNFa in the bronchoalveolar lavage

Full Information

NCT ID

NCT01070654

First Posted

February 16, 2010

Last Updated

July 6, 2010

Sponsor

Azienda Ospedaliero, Universitaria Pisana

1. Study Identification

Unique Protocol Identification Number

NCT01070654

Brief Title

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

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Unknown status

Study Start Date

June 2010 (undefined)

Primary Completion Date

October 2010 (Anticipated)

Study Completion Date

December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Azienda Ospedaliero, Universitaria Pisana

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Insufficiency, Respiratory Distress Syndrome, Adult

Keywords

ARDS, Recruitment Manoeuvres, PEEP, Cytokines, Respiratory Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

40/30 Recruitment Manoeuvre

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

40/30 recruitment manoeuvre

Other Intervention Name(s)

Recruitment Manoeuvres, ARDS open lung strategy, PEEP

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

continuous positive airway pressure (CPAP)

Intervention Description

continuous positive airway pressure (CPAP)

Primary Outcome Measure Information:

Title

Plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa

Time Frame

T0 (baseline), T4 (3 hrs), T5 (12 hrs)

Title

Plasmatic concentration of Nitric Oxide

Time Frame

T0 (baseline), T6 (24 hrs)

Title

Lung mechanics (Peak pressure, Mean pressure, Compliance, Resistance) Gas exchange (pH, PaO2, PaCO2, HCO3-, SaO2, PaO2/FiO2) Haemodynamics (Mean arterial pressure, Heart rate)

Time Frame

T0 (baseline), T1 (30 secs), T2 (1 hr), T3 (2 hrs)

Title

Echographic score of lung aeration

Time Frame

T0 (baseline), T2 (1 hr), T4 (3 hrs)

Title

Chest X-Ray

Time Frame

T6 (24 hrs)

Secondary Outcome Measure Information:

Title

Levels of IL-1, IL6, IL-8, IL-19, TNFa in the bronchoalveolar lavage

Time Frame

T0 (baseline), T4 (3 hrs)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Francesco Forfori

Phone

+39050993234

forforiden@libero.it

First Name & Middle Initial & Last Name or Official Title & Degree

Giuseppe Mancino

Phone

+393471216535

giumancino@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francesco Forfori

Organizational Affiliation

UO IV Anestesia e Rianimazione

Official's Role

Principal Investigator

Facility Information:

Facility Name

U.O. Anestesia e Rianimazione IV, Azienda Ospedaliero Universitaria Pisana

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francesco Forfori

Phone

+39050993234

forforiden@libero.it

First Name & Middle Initial & Last Name & Degree

Giuseppe Mancino

First Name & Middle Initial & Last Name & Degree

Francesco Forfori

First Name & Middle Initial & Last Name & Degree

Antonio Abramo

12. IPD Sharing Statement

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Inflammatory Effects of a Lung Recruitment Manoeuvre

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