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Inflammatory Effects of a Lung Recruitment Manoeuvre

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ClinicalTrials.gov Identifier: NCT01070654
Recruitment Status : Unknown
Verified February 2010 by Azienda Ospedaliero, Universitaria Pisana.
Recruitment status was:  Recruiting
First Posted : February 18, 2010
Last Update Posted : July 7, 2010
Sponsor:
Information provided by:
Azienda Ospedaliero, Universitaria Pisana

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.


Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Respiratory Distress Syndrome, Adult Procedure: 40/30 recruitment manoeuvre Device: continuous positive airway pressure (CPAP) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2010
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : December 2010


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:
  • Recruitment Manoeuvres
  • ARDS open lung strategy
  • PEEP

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




Primary Outcome Measures :
  1. Plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa [ Time Frame: T0 (baseline), T4 (3 hrs), T5 (12 hrs) ]
  2. Plasmatic concentration of Nitric Oxide [ Time Frame: T0 (baseline), T6 (24 hrs) ]
  3. 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) ]
  4. Echographic score of lung aeration [ Time Frame: T0 (baseline), T2 (1 hr), T4 (3 hrs) ]
  5. Chest X-Ray [ Time Frame: T6 (24 hrs) ]

Secondary Outcome Measures :
  1. Levels of IL-1, IL6, IL-8, IL-19, TNFa in the bronchoalveolar lavage [ Time Frame: T0 (baseline), T4 (3 hrs) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01070654


Contacts
Contact: Francesco Forfori +39050993234 forforiden@libero.it
Contact: Giuseppe Mancino +393471216535 giumancino@gmail.com

Locations
Italy
U.O. Anestesia e Rianimazione IV, Azienda Ospedaliero Universitaria Pisana Recruiting
Pisa, Italy, 56126
Contact: Francesco Forfori    +39050993234    forforiden@libero.it   
Sub-Investigator: Giuseppe Mancino         
Principal Investigator: Francesco Forfori         
Principal Investigator: Antonio Abramo         
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Pisana
Investigators
Principal Investigator: Francesco Forfori UO IV Anestesia e Rianimazione

Responsible Party: Dr Francesco Forfori, UO IV Anestesia e Rianimazione
ClinicalTrials.gov Identifier: NCT01070654     History of Changes
Other Study ID Numbers: RM0910
RMSGMFF ( Other Identifier: IV Anestesia e Rianimazione )
First Posted: February 18, 2010    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: February 2010

Keywords provided by Azienda Ospedaliero, Universitaria Pisana:
ARDS
Recruitment Manoeuvres
PEEP
Cytokines
Respiratory Insufficiency

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Lung Injury