## Protocol Section
### Identification Module
**NCT ID:** NCT06425354

**Brief Title:** Use of 'Mechanical Power' as a Predictor of Increased Serum and Pulmonary Proinflammatory Cytokine Concentrations in Patients With Acute Hypoxemic Respiratory Failure: A Prospective Observational Study

**Official Title:** Use of 'Mechanical Power' as a Predictor of Increased Serum and Pulmonary Proinflammatory Cytokine Concentrations in Patients With Acute Hypoxemic Respiratory Failure: A Prospective Observational Study

#### Organization Study ID Info
**ID:** RIA24.1
#### Organization
**Class:** OTHER
**Full Name:** University of Roma La Sapienza
### Status Module
#### Completion Date
**Date:** 2027-06-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-04-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-04-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Roma La Sapienza

#### Responsible Party

**Investigator Affiliation:** University of Roma La Sapienza

**Investigator Full Name:** Francesco Alessandri

**Investigator Title:** Prof

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aim of this study is to report the proportion of patients with acute hypoxemic respiratory failyre (AHRF) undergoing mechanical ventilation who exceed 17 J/min of mechanical power (MP) and the difference in terms of proinflammatory cytokine concentration in blood samples and bronchoalveolar lavage.

The main questions it aims to answer are:

1. Which is the proportion of patients who exceed 17 J/min of mechanical power (MP) during the first 72 hours of mechanical ventilation?
2. Is there a difference in terms of cytokine concentration in patients undergoing mechanical power \>17 J/min compared to \<17 J/min?

Patients will be divided into two groups based on respiratory mechanics measurements: low MP group (average MP \<17 J/min) and high MP group (average MP ≥17 J/min). The researchers will collect blood and BAL samples and perform cytokine assays.

### Conditions Module

**Conditions:**

- Mechanical Power

### Design Module

#### Bio Spec

**Description:** plasma serum and BAL

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Mechanical ventilatiom

**Name:** Mechanical ventilation

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Proportion of patients with AHRF undergoing mechanical ventilation who exceed 17 J/min of MP

**Measure:** Patients who exceed 17 J/min of MP

**Time Frame:** 4 years

#### Secondary Outcomes

**Description:** Difference in terms of proinflammatory cytokine concentration in blood samples and bronchoalveolar lavage.

**Measure:** Inflammatory cytokines

**Time Frame:** 4 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with AHRF (P/F \<300 mmHg) undergoing invasive mechanical ventilation within 7 days from the onset of symptoms
* Invasive mechanical ventilation for less than 6 hours
* Evidence of newly developed lung consolidation on chest imaging (X-ray, CT)
* Age ≥18 years

Exclusion Criteria:

* Prior invasive mechanical ventilation during the same hospitalization
* Tracheostomy
* Severe anemia (Hb\<7g/dL)
* Severe neutropenia
* Renal insufficiency or RRT (Renal Replacement Therapy)
* Noradrenaline \>0.5 mcg/kg/min
* Pregnancy
* Extracorporeal circulation (ECCO2R, ECMO)
* Life expectancy \<24 hours as clinically judged
* Lack of consent

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with AHRF undergoing mechanical ventilation

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Roma

**Contacts:**

***Contact 1:***

- **Email:** f.alessandri@uniroma1.it

- **Name:** Francesco Alessandri

- **Phone:** 0039 0649978924

- **Role:** CONTACT

***Contact 2:***

- **Name:** Giovanni Giordano

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Italy

**Facility:** Sapienza University of Rome

**Status:** RECRUITING

**Zip:** 00161

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## 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: Acute Hypoxemic 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

### Misc Info Module

- Version Holder: 2024-05-31
