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Lung DiffusionNCT01503879

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

An observational study of Lung Diffusion and Acute Respiratory Failure, run by San Gerardo Hospital at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Lung Diffusion, Acute Respiratory Failure
How many people
20 participants
Where
1 siteItaly
Study dates
Oct 2011to Oct 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Roberto Fumagalli, MD contact

+390392339269

roberto.fumagalli@unimib.it

Italy1 site, 1 recruiting
  • Ospedale San Gerardo

    Monza, MB

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

    Roberto Fumagalli, MD

    Recruiting

Other trials in Italy

About this study

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).

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.

Keywords
general anaesthesia, invasive mechanical ventilation, DLCO, SPB

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2012 (estimated)
  2. Study startOct 2011
  3. Study completionOct 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01503879
Sponsor's protocol ID
ARHSG 10 2010 DLCO1
Status last verified
Aug 2012
First submitted
31 Dec 2011
Last updated
29 Aug 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Diffusion and Acute Respiratory Failure, run by San Gerardo Hospital at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Roberto Fumagalli, MD (+390392339269, roberto.fumagalli@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2012.

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