Inflammatory Effects of a Lung Recruitment Manoeuvre
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
2 other identifiers
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2010
CompletedFirst Posted
Study publicly available on registry
February 18, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJuly 7, 2010
February 1, 2010
4 months
February 16, 2010
July 6, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa
T0 (baseline), T4 (3 hrs), T5 (12 hrs)
Plasmatic concentration of Nitric Oxide
T0 (baseline), T6 (24 hrs)
Lung mechanics (Peak pressure, Mean pressure, Compliance, Resistance) Gas exchange (pH, PaO2, PaCO2, HCO3-, SaO2, PaO2/FiO2) Haemodynamics (Mean arterial pressure, Heart rate)
T0 (baseline), T1 (30 secs), T2 (1 hr), T3 (2 hrs)
Echographic score of lung aeration
T0 (baseline), T2 (1 hr), T4 (3 hrs)
Chest X-Ray
T6 (24 hrs)
Secondary Outcomes (1)
Levels of IL-1, IL6, IL-8, IL-19, TNFa in the bronchoalveolar lavage
T0 (baseline), T4 (3 hrs)
Study Arms (1)
40/30 Recruitment Manoeuvre
EXPERIMENTALPatients 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
Interventions
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)
Eligibility Criteria
You may qualify if:
- Mechanical Ventilation
- Arterial catheter inserted
- Hypoxemic respiratory failure (Pa02/FiO2 \<300)
- Radiological evidence of atelectasis or pulmonary infiltrates in the CXR
- Informed consent
You may not qualify if:
- Elevated intracranial pressure \>25 mmHg
- Bronchopulmonary fistula
- Emphysema
- Kidney or Liver failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
U.O. Anestesia e Rianimazione IV, Azienda Ospedaliero Universitaria Pisana
Pisa, Pisa, 56126, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Forfori
UO IV Anestesia e Rianimazione
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 16, 2010
First Posted
February 18, 2010
Study Start
June 1, 2010
Primary Completion
October 1, 2010
Study Completion
December 1, 2010
Last Updated
July 7, 2010
Record last verified: 2010-02