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Inflammatory Effects of a Lung Recruitment Manoeuvre

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Azienda Ospedaliero, Universitaria Pisana.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Azienda Ospedaliero, Universitaria Pisana
ClinicalTrials.gov Identifier:
NCT01070654
First received: February 16, 2010
Last updated: July 6, 2010
Last verified: February 2010
History of Changes
  Purpose

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 Intervention
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
 Procedure: 40/30 recruitment manoeuvre
Device: continuous positive airway pressure (CPAP)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Azienda Ospedaliero, Universitaria Pisana:

Primary Outcome Measures:
  • Plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa [ Time Frame: T0 (baseline), T4 (3 hrs), T5 (12 hrs) ] [ Designated as safety issue: No ]
  • Plasmatic concentration of Nitric Oxide [ Time Frame: T0 (baseline), T6 (24 hrs) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Echographic score of lung aeration [ Time Frame: T0 (baseline), T2 (1 hr), T4 (3 hrs) ] [ Designated as safety issue: No ]
  • Chest X-Ray [ Time Frame: T6 (24 hrs) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Levels of IL-1, IL6, IL-8, IL-19, TNFa in the bronchoalveolar lavage [ Time Frame: T0 (baseline), T4 (3 hrs) ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: June 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dr Francesco Forfori, UO IV Anestesia e Rianimazione
ClinicalTrials.gov Identifier: NCT01070654     History of Changes
Other Study ID Numbers: RM0910, RMSGMFF
Study First Received: February 16, 2010
Last Updated: July 6, 2010
Health Authority: Italy: Ethics Committee

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
Acute Lung Injury
Respiratory Insufficiency
Lung Diseases
 Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on May 19, 2013