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Inflammatory Effects of a Lung Recruitment Manoeuvre

A

Azienda Ospedaliero, Universitaria Pisana

Status

Unknown

Conditions

Respiratory Insufficiency
Respiratory Distress Syndrome, Adult

Treatments

Device: continuous positive airway pressure (CPAP)
Procedure: 40/30 recruitment manoeuvre

Study type

Interventional

Funder types

Other

Identifiers

NCT01070654
RMSGMFF (Other Identifier)
RM0910

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

40/30 Recruitment Manoeuvre
Experimental group
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
Treatment:
Device: continuous positive airway pressure (CPAP)
Procedure: 40/30 recruitment manoeuvre

Trial contacts and locations

1

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Central trial contact

Giuseppe Mancino; Francesco Forfori

Data sourced from clinicaltrials.gov

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