Evaluation of Gas Exchange by the Measurement of Lung Diffusion for Carbon Monoxide During General Anaesthesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by San Gerardo Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Prof. Roberto Fumagalli's, San Gerardo Hospital
ClinicalTrials.gov Identifier:
NCT01503879
First received: December 31, 2011
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

Mechanical ventilation is a therapeutic method used in order to keep gas exchange adequate to cell metabolism in patients with acute respiratory failure. It is currently proved that, although on one hand the use of this method keeps gas exchange, on the other hand it promotes and supports pulmonary inflammatory processes (VILI). A recent study about the effect of positive end-expiratory pressure (PEEP) on DLCO (diffusing capacity of the lung for carbon monoxide) in patients undergoing invasive mechanical ventilation has proved that patients without any evident pulmonary disease (negative medical history, negative chest clinical examination, normal chest X-ray radiography and normal arterial oxygen tension [PaO2]) after 24 hours of invasive mechanical ventilation show a significant worsening of pulmonary gas exchange properties. The authors have supposed that this worsening may be caused by an early alteration of alveolar-capillary membrane caused by mechanical ventilation itself. This hypothesis finds support in some studies carried out on animal models which founds that mechanical ventilation, even when low tidal volumes (Vt) are set for a few hours, is able to induce lung injury (as shown by histologic findings). The most sensitive and specific tools the investigators can currently rely on for the study of alveolar-capillary membrane are the measurement of diffusing capacity of the lung for carbon monoxide (DLCO) and the evaluation of plasmatic levels of pulmonary surfactant protein B (SPB). DLCO is a standard, widely diffused technique for the evaluation of functional alterations of alveolar-capillary membrane and it is currently available also for patients undergoing invasive mechanical ventilation. SBP is produced by type II pneumocytes in the alveoli. An increase of its plasmatic levels is correlated to a decay of pulmonary gas exchange; SPB thus can be considered an alveolar-capillary membrane anatomical damage marker.

The primary end-point of this study is to evaluate the changes of anatomical (SPB) and functional (DLCO) features of alveolar-capillary membrane between the spontaneous breathing and mechanical ventilation as well as the progressive changes affecting DLCO and SPB over time during general anaesthesia and mechanical ventilation in patients with otherwise healthy lung undergoing elective surgery. This in order to check the timing of the observed worsening of alveolar-capillary membrane function, and to find out if the process is progressive in time.

The secondary end point is to check if the alterations of functional features of alveolar membrane (DLCO) are proportionate to the increase of alveolar injury marker (SPB), in order to understand if the worsening of alveolar-capillary membrane function is to be attributable to an anatomical damage or to a physiologic change of the ventilation-perfusion matching.


Condition
Lung Diffusion
Acute Respiratory Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effects of General Anaesthesia and Invasive Mechanical Ventilation on Alveolo-capillary Membrane: Evaluation of Gas Exchange by the Measurement of Lung Diffusion for Carbon Monoxide (DLCO) and Plasma Dosage of Surfactant Protein-B (SPB).

Resource links provided by NLM:


Further study details as provided by San Gerardo Hospital:

Biospecimen Retention:   Samples Without DNA

surfactant protein B


Estimated Enrollment: 20
Study Start Date: October 2011
Estimated Study Completion Date: October 2012
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients undergoing elective surgery lasting more than three hours, requiring general anaesthesia and invasive mechanical ventilation.

Criteria

Inclusion Criteria:

  • over 18 years of age
  • undergoing a non-thoracic, non-laparoscopic surgery, lasting more than three hours and requiring general anaesthesia and invasive mechanical ventilation

Exclusion Criteria:

  • COPD 3 Gold stage or above
  • ASA physical status classification system 4 or above
  • heart failure NYHA 2 or above
  • chronic kidney disease
  • axillary temperature over 38 °C
  • BMI over 30 kg/m^2
  • pregnancy or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01503879

Contacts
Contact: Roberto Fumagalli, MD +390392339269 roberto.fumagalli@unimib.it

Locations
Italy
Ospedale San Gerardo Recruiting
Monza, MB, Italy
Contact: Roberto Fumagalli, MD    +390392339269    roberto.fumagalli@unimib.it   
Principal Investigator: Roberto Fumagalli, MD         
Sponsors and Collaborators
San Gerardo Hospital
Investigators
Principal Investigator: Roberto MD Fumagalli Milano Bicocca University
  More Information

No publications provided

Responsible Party: Prof. Roberto Fumagalli's, MD, San Gerardo Hospital
ClinicalTrials.gov Identifier: NCT01503879     History of Changes
Other Study ID Numbers: ARHSG 10 2010 DLCO1
Study First Received: December 31, 2011
Last Updated: August 28, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by San Gerardo Hospital:
general anaesthesia
invasive mechanical ventilation
DLCO
SPB

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Anesthetics
Carbon Monoxide
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 22, 2014