Inflammatory Effects of a Lung Recruitment Manoeuvre

NCT ID: NCT01070654

Last Updated: 2010-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Respiratory Insufficiency Respiratory Distress Syndrome, Adult

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

40/30 recruitment manoeuvre

Intervention Type PROCEDURE

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.

continuous positive airway pressure (CPAP)

Intervention Type DEVICE

continuous positive airway pressure (CPAP)

Interventions

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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.

Intervention Type PROCEDURE

continuous positive airway pressure (CPAP)

continuous positive airway pressure (CPAP)

Intervention Type DEVICE

Other Intervention Names

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Recruitment Manoeuvres ARDS open lung strategy PEEP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role lead

Responsible Party

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UO IV Anestesia e Rianimazione

Principal Investigators

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Francesco Forfori

Role: PRINCIPAL_INVESTIGATOR

UO IV Anestesia e Rianimazione

Locations

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

Pisa, Pisa, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesco Forfori

Role: CONTACT

+39050993234

Giuseppe Mancino

Role: CONTACT

+393471216535

Facility Contacts

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Francesco Forfori

Role: primary

+39050993234

Other Identifiers

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RMSGMFF

Identifier Type: OTHER

Identifier Source: secondary_id

RM0910

Identifier Type: -

Identifier Source: org_study_id

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