## Protocol Section
### Identification Module
**NCT ID:** NCT06413472

**Brief Title:** Comparing Formulations of Mechanical Power Using Geometric Methods

**Official Title:** Comparing Formulations of Mechanical Power Using Geometric Methods at Different Inspiratory Rise and Pause Times: A Validation Study

#### Organization Study ID Info
**ID:** 2024-37
#### Organization
**Class:** OTHER_GOV
**Full Name:** Başakşehir Çam & Sakura City Hospital
### Status Module
#### Completion Date
**Date:** 2024-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-04-01

**Type:** ACTUAL

#### Start Date
**Date:** 2024-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Başakşehir Çam & Sakura City Hospital

#### Responsible Party

**Investigator Affiliation:** Başakşehir Çam & Sakura City Hospital

**Investigator Full Name:** Furkan Tontu

**Investigator Title:** Doctor of Anesthesiology and Reanimation

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** We aimed to compare different formulations of mechanical power using geometric methods at varying inspiratory rise and pause times.

**Detailed Description:** One of the formulas used to calculate mechanical power (MP) is the dynamic mechanical power formula (MPdyn) developed by Asar et al. This formula, in Volume-Controlled Ventilation (VCV) mode, calculates the same MP values as the comprehensive mechanical power formula (MPrs) from Gattinoni et al., without requiring the inspiratory resistance value. Similarly, in Pressure-Controlled Ventilation (PCV) mode, the MPdyn formula calculates mechanical power values comparable to those from the mechanical power formula (MPlm) proposed by Trinkle et al., also without the need for inspiratory resistance. However, the MPdyn formula has not been compared with the geometric method, considered the gold standard for mechanical power calculation. This limitation has been highlighted as a drawback for clinical use, particularly when applying the formula in both VCV and PCV modes.

In this study, we aim to compare the MPdyn formula with the MPLM and MPrs formulas, against the standard geometric method (MPstd), for mechanical power calculations in ARDS patients during both pressure-controlled and volume-controlled ventilation, at varying inspiratory rise (Tslope) and pause times (Tpause).

### Conditions Module

**Conditions:**

- Ventilator-Induced Lung Injury

- Acute Respiratory Distress Syndrome

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 38

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Intubated patients with a diagnosis of ARDS in the intensive care unit, ventilated using Pressure-Controlled Ventilation (PCV).

**Intervention Names:**

- Procedure: Mechanical ventilator adjustment for PCV

**Label:** ARDS patients-PCV

#### Arm Group 2

**Description:** Intubated patients with a diagnosis of ARDS in the intensive care unit, ventilated using Volume-Controlled Ventilation (VCV).

**Intervention Names:**

- Procedure: Mechanical ventilator adjustment for VCV

**Label:** ARDS patients-VCV

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ARDS patients-PCV

**Description:** In Pressure-Controlled Ventilation (PCV) mode, adjustments to the Tslope time will be made at every 5-minute interval, with incremental increases of 5% (ranging from 5 to 20), for each I:E ratio (1:2 and 1:1). After each adjustment, screenshots of the mechanical ventilator (P-V loop screenshots) will be obtained (Figure 1). A total of 40 P-V loop screenshots will be captured over a 40-minute period (20 for the 1:2 ratio and 20 for the 1:1 ratio), which will be stored in the ventilator's memory. The stored data will then be transferred from the ventilator's memory to a computer via a flash drive.

**Name:** Mechanical ventilator adjustment for PCV

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- ARDS patients-VCV

**Description:** In Volume-Controlled Ventilation (VCV) mode, at each I:E ratio (1:2 and 1:1), adjustments to the Tpause duration will be made every 40 minutes, with 10% increases at intervals of 10%, 20%, and 30%; for the Tslope duration, adjustments will be made every 5 minutes with 5% increases at intervals of 5%, 10%, 15%, and 20%. This will result in a total of 120 P-V loop screenshots taken over a 120-minute period (60 for the 1:2 ratio, with 4x5x3=60, and 60 for the 1:1 ratio, also with 4x5x3=60). These screenshots will be stored in the ventilator's memory and subsequently transferred to a computer via a flash drive.

**Name:** Mechanical ventilator adjustment for VCV

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** The mechanical power value measured using the geometric method (MPstd).

**Measure:** MPstd

**Time Frame:** 120 minute

**Description:** The mechanical power value measured using the dynamic mechanical power formula (MPdyn) developed by Asar et al.

**Measure:** MPdyn

**Time Frame:** 120 minute

**Description:** The mechanical power value measured using Gattinoni et al.'s comprehensive formula (MPrs).

**Measure:** MPrs

**Time Frame:** 120 minute

**Description:** The mechanical power value measured using the formula developed by Trinkle et al (MPlm).

**Measure:** MPlm

**Time Frame:** 120 minute

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

The study will include ARDS patients who are deeply sedated and ventilated in Pressure-Controlled Ventilation (PCV or PRVC) or Volume-Controlled Ventilation (VCV) modes during the 24-48 hour period of their stay in the intensive care unit.

Exclusion Criteria:

Patients with incomplete data, those with COPD and heart failure, pregnant patients, those with a thoracopleural fistula, and hemodynamically unstable patients will be excluded from the study.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** "Patients with a diagnosis of ARDS in the general intensive care unit of the Anesthesiology and Reanimation Clinic at Bakırköy Dr. Sadi Konuk Training and Research Hospital."

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Basaksehir Cam Sakura City Hospital

### IPD Sharing Statement Module

**Description:** Not yet decided.

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** Trinkle CA, Broaddus RN, Sturgill JL, Waters CM, Morris PE. Simple, accurate calculation of mechanical power in pressure controlled ventilation (PCV). Intensive Care Med Exp. 2022 May 30;10(1):22. doi: 10.1186/s40635-022-00448-5.

**PMID:** 35644896

**Citation:** Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.

**PMID:** 27620287

**Citation:** Serpa Neto A, Deliberato RO, Johnson AEW, Bos LD, Amorim P, Pereira SM, Cazati DC, Cordioli RL, Correa TD, Pollard TJ, Schettino GPP, Timenetsky KT, Celi LA, Pelosi P, Gama de Abreu M, Schultz MJ; PROVE Network Investigators. Mechanical power of ventilation is associated with mortality in critically ill patients: an analysis of patients in two observational cohorts. Intensive Care Med. 2018 Nov;44(11):1914-1922. doi: 10.1007/s00134-018-5375-6. Epub 2018 Oct 5.

**PMID:** 30291378

**Citation:** Asar S, Acicbe O, Cukurova Z, Hergunsel GO, Canan E, Cakar N. Bedside dynamic calculation of mechanical power: A validation study. J Crit Care. 2020 Apr;56:167-170. doi: 10.1016/j.jcrc.2019.12.027. Epub 2020 Jan 2.

**PMID:** 31931417

**Citation:** Giosa L, Busana M, Pasticci I, Bonifazi M, Macri MM, Romitti F, Vassalli F, Chiumello D, Quintel M, Marini JJ, Gattinoni L. Mechanical power at a glance: a simple surrogate for volume-controlled ventilation. Intensive Care Med Exp. 2019 Nov 27;7(1):61. doi: 10.1186/s40635-019-0276-8.

**PMID:** 31773328

**Citation:** Chi Y, He H, Long Y. A simple method of mechanical power calculation: using mean airway pressure to replace plateau pressure. J Clin Monit Comput. 2021 Oct;35(5):1139-1147. doi: 10.1007/s10877-020-00575-y. Epub 2020 Aug 11.

**PMID:** 32780353

**Citation:** Becher T, van der Staay M, Schadler D, Frerichs I, Weiler N. Calculation of mechanical power for pressure-controlled ventilation. Intensive Care Med. 2019 Sep;45(9):1321-1323. doi: 10.1007/s00134-019-05636-8. Epub 2019 May 17. No abstract available.

**PMID:** 31101961

**Citation:** van der Meijden S, Molenaar M, Somhorst P, Schoe A. Calculating mechanical power for pressure-controlled ventilation. Intensive Care Med. 2019 Oct;45(10):1495-1497. doi: 10.1007/s00134-019-05698-8. Epub 2019 Jul 29. No abstract available.

**PMID:** 31359082

**Citation:** Asar S, Acicbe O, Sabaz MS, Kucur Tulubas E, Hergunsel GO, Cukurova Z, Canan E, Cakar N. Simplified calculation of mechanical power for pressure controlled ventilation in Covid-19 ARDS patients. Minerva Anestesiol. 2022 Jan-Feb;88(1-2):42-50. doi: 10.23736/S0375-9393.21.15741-4.

**PMID:** 35224956

**Citation:** Acicbe O, Ozgur CY, Rahimi P, Canan E, Asar S, Cukurova Z. The effect of inspiratory rise time on mechanical power calculations in pressure control ventilation: dynamic approach. Intensive Care Med Exp. 2023 Dec 20;11(1):98. doi: 10.1186/s40635-023-00584-6.

**PMID:** 38117345

**Citation:** ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

**PMID:** 22797452

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000012120

- Term: Respiration Disorders

- ID: D000007235

- Term: Infant, Premature, Diseases

- ID: D000007232

- Term: Infant, Newborn, Diseases

- ID: D000013898

- Term: Thoracic Injuries

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M27137

- Name: Respiratory Aspiration

- Relevance: LOW

- As Found: Unknown

- ID: M14965

- Name: Respiratory Distress Syndrome

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: M14964

- Name: Respiratory Distress Syndrome, Newborn

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: M28144

- Name: Acute Lung Injury

- Relevance: HIGH

- As Found: Acute Respiratory Distress Syndrome

- ID: M28143

- Name: Lung Injury

- Relevance: HIGH

- As Found: Lung Injury

- ID: M28152

- Name: Ventilator-Induced Lung Injury

- Relevance: HIGH

- As Found: Ventilator-Induced Lung Injury

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M25869

- Name: Premature Birth

- Relevance: LOW

- As Found: Unknown

- ID: M10279

- Name: Infant, Premature, Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10276

- Name: Infant, Newborn, Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16657

- Name: Thoracic Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: T4927

- Name: Respiratory Distress Syndrome, Infant

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: T192

- Name: Acute Respiratory Distress Syndrome

- Relevance: HIGH

- As Found: Acute Respiratory Distress Syndrome

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012128

- Term: Respiratory Distress Syndrome

- ID: D000012127

- Term: Respiratory Distress Syndrome, Newborn

- ID: D000055371

- Term: Acute Lung Injury

- ID: D000055370

- Term: Lung Injury

- ID: D000055397

- Term: Ventilator-Induced Lung Injury

### Misc Info Module

- Version Holder: 2024-05-31
