Closed Loop Ventilation With High Tidal Volumes and Safe Transpulmonary Pressure in COPD (COPD-SAFE)

NCT04089111 | Not Yet Recruiting

• 1 other identifier: IGHCEAH-ICU-4
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the safety and efficacy of high tidal volumes generated by "Adapted Support Ventilation (ASV) mode' in mechanically ventilated severe COPD patients. Every patient will be ventilated consecutively with ASV and Volume Control (VC) modes at 2 different levels of minute volume in 2 sets. ASV mode is expected to be safe measured by adequate inspiratory transpulmonary pressures and expected to be as effective as VC mode with lower intrinsic positive end expiratory pressure (iPEEP) levels.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Mechanical ventilation; Adaptive Support Ventilation; Transpulmonary pressure; Intrinsic PEEP; Safety

Outcome Measures

Primary Outcomes (1)

• Transpulmonary inspiratory pressure (Ptinsp)

  Ptpinsp will be measured with an inspiratory pause maneuver.

  30'th minute of each intervention arm

Secondary Outcomes (1)

• Intrinsic Positive End Expiratory Pressure (PEEPi)

  30'th minute of each intervention arm

Other Outcomes (3)

• Mean arterial pressure

  30'th minute of each intervention arm

• PaO2, FiO2 ratio

  30'th minute of each intervention arm

• Heart rate

  30'th minute of each intervention arm

Study Arms (4)

1.1. ASV, MV target 100%

EXPERIMENTAL

Patients will be ventilated with ASV mode. Tidal volume, ventilation frequency, inspiratory duration will be automatically adjusted by the mechanical ventilator.

Other: Minute volume target of 100%

1.2. Volume control, MV target %100

ACTIVE COMPARATOR

Patients will be ventilated with volume control mode. A tidal volume of 6-8 ml/kg will be used. I:E ratio will be set as 1:3 Ventilation frequency will be adjusted to reach the same volume target calculated in arm1.

Other: Minute volume target of 100%

2.1. ASV, MV target to reach PaCO2< 45 mmHg

EXPERIMENTAL

Patients will be ventilated with ASV mode. Tidal volume, ventilation frequency, inspiratory duration will be automatically adjusted by the mechanical ventilator.

Other: Minute volume target to reach PaCO2 less than 45% (high tidal volume)

2.2. Volume control, MV target to reach PaCO2< 45 mmHg

ACTIVE COMPARATOR

Patients will be ventilated with volume control mode. A tidal volume of 6-8 ml/kg will be used. I:E ratio will be set as 1:3. Ventilation frequency will be adjusted to reach the target PaCO2 level

Other: Minute volume target to reach PaCO2 less than 45% (high tidal volume)

Interventions

Minute volume target of 100% OTHER

Patients will be ventilated to reach minute volume target of %100 (100 ml per ideal body weight).

1.1. ASV, MV target 100%; 1.2. Volume control, MV target %100

Minute volume target to reach PaCO2 less than 45% (high tidal volume) OTHER

Patients will be ventilated to reach minute volume target associated with PaCO2 less than 45%.

2.1. ASV, MV target to reach PaCO2< 45 mmHg; 2.2. Volume control, MV target to reach PaCO2< 45 mmHg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute exacerbation of Chronic Obstructive Lung Disease
• Being intubated for less than 24 hours
• Not being planned to be extubated in 24 hours
• Expiratory time constant (RCexp) more than \> 2.0 s

You may not qualify if:

• Restrictive lung pathologies
• Impaired hemodynamic status
• Esophageal pathologies
• Bronchopleural fistula

Sponsors & Collaborators

• Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital: lead

Study Sites (1)

Izmir Dr. Suat Seren Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit

Izmir, Yenisehir, 35550, Turkey (Türkiye)

Location

Related Publications (4)

• Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.

  PMID: 19001507 BACKGROUND

• Grieco DL, Chen L, Brochard L. Transpulmonary pressure: importance and limits. Ann Transl Med. 2017 Jul;5(14):285. doi: 10.21037/atm.2017.07.22.

  PMID: 28828360 BACKGROUND

• Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.

  PMID: 27334266 BACKGROUND

• Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI.

  PMID: 24467647 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Positive-Pressure Respiration, Intrinsic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders

Study Officials

• Sami C Kirakli, MD

  Dr. Suat Seren Chest Diseases and Surgery Educatin and Resarch Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sami C Kirakli, MD

CONTACT

+905052352024; samicenk.kirakli@sbu.edu.tr

Burcu Acar Cinleti, MD

CONTACT

+905075022780; burcu_acar911@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will not be aware of the procedure or ventilation modes that will be performed. Outcomes will be analyzed by an independent statistician.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Cenk Kirakli. M.D.

Model Details: Patients will be ventilated for two different minute volume targets in two sets. 'Adapted support ventilation' and 'volume control (VC)' modes will be used consecutively in each set. Every patient will be ventilated 1.1. ASV with minute volume target of % 100; 1.2. VC with same MV target; 2.1 ASV with MV target associated with PaCo2 less than 45 mmHg; 2.2 VC with same MV target. Sequence of ventilation modes wıll be randomized within each group.

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 13, 2019
• Study Start: December 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)