## Protocol Section
### Identification Module
**NCT ID:** NCT01503879

**Brief Title:** Evaluation of Gas Exchange by the Measurement of Lung Diffusion for Carbon Monoxide During General Anaesthesia

**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).

#### Organization Study ID Info
**ID:** ARHSG 10 2010 DLCO1
#### Organization
**Class:** OTHER
**Full Name:** San Gerardo Hospital
### Status Module
#### Completion Date
**Date:** 2012-10

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2012-08-29

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-08-28

**Overall Status:** UNKNOWN

#### Start Date
**Date:** 2011-10

**Status Verified Date:** 2012-08

#### Study First Post Date
**Date:** 2012-01-04
**Type:** ESTIMATED
**Study First Submit Date:** 2011-12-31
**Study First Submit QC Date:** 2012-01-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** San Gerardo Hospital

#### Responsible Party

**Investigator Affiliation:** San Gerardo Hospital

**Investigator Full Name:** Prof. Roberto Fumagalli's

**Investigator Title:** MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief 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 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.

### Conditions Module

**Conditions:**

- Lung Diffusion

- Acute Respiratory Failure

**Keywords:**

- general anaesthesia

- invasive mechanical ventilation

- DLCO

- SPB

### Design Module

#### Bio Spec

**Description:** surfactant protein B

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Eligibility Module

**Eligibility 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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** roberto.fumagalli@unimib.it

**Name:** Roberto Fumagalli, MD

**Phone:** +390392339269

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Monza

**Contacts:**

***Contact 1:***

- **Email:** roberto.fumagalli@unimib.it

- **Name:** Roberto Fumagalli, MD

- **Phone:** +390392339269

- **Role:** CONTACT

***Contact 2:***

- **Name:** Roberto Fumagalli, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Italy

**Facility:** Ospedale San Gerardo

**State:** MB

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Milano Bicocca University

**Name:** Roberto MD Fumagalli

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M14968

- Name: Respiratory Insufficiency

- Relevance: HIGH

- As Found: Respiratory Failure

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012131

- Term: Respiratory Insufficiency

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Resp

- Name: Respiratory System Agents

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M14517

- Name: Pulmonary Surfactants

- Relevance: LOW

- As Found: Unknown

- ID: M5506

- Name: Carbon Monoxide

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
