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

Chronic Obstructive Pulmonary Disease Clinical Trial

— COPD-SAFE  

Official title:

Does Automatically Generated Tidal Volumes With Closed-loop Ventilation Leads to Safe Transpulmonary Pressures in Intubated Chronic Obstructive Pulmonary Disease Patients?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04089111
• Other study ID #: IGHCEAH-ICU-4
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: March 2024

Study information

• Verified date: May 2023
• Source: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
• Contact: Sami C Kirakli, MD
• Phone: +905052352024
• Email: samicenk.kirakli[@]sbu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD) may require mechanical ventilation. Various mechanical ventilation strategies and modes can be used to manage respiratory insufficiency in such patients. High tidal volumes required for mechanical ventilation of patients with obstructive pathologies is a well-known fact. Adapted Support Ventilation (ASV) is an intelligent closed-loop mechanical ventilation mode which automatically adjusts ventilation to lung mechanics. Led by measured lung mechanics, ASV mode often generates higher than usual tidal volumes during mechanical ventilation of COPD patients, particularly if the minute volume (MV) target is high. Thus, the effects of high tidal volumes on inspiratory transpulmonary pressure (Ptp), and whether Ptp stays within safe limits during ASV mode is of great interest.

Patients with acute exacerbation of COPD who required mechanical ventilation will be enrolled in the first 24 hours of admission to the intensive care unit. All patients will be deeply sedated. An esophageal balloon catheter will be inserted in order to measure transpulmonary pressure. 100 % minute volume target will be calculated in advance as 100 ml per ideal body weight.

Patients will be ventilated with two different MV targets in two sets. 'Adapted support ventilation' and 'volume control (VC)' modes will be used consecutively within each set. While the target minute volume will be 100 % in the first set, the volume target in the second set will be tuned to decrease patients PaCO2 below 45 mmHg. The sequence of ventilation mode will be randomized within each set. Ventilation periods will be 30 minutes with 15 minutes washout period in between. İf Ptp increase above 20 cmH20 at any ventilation mode, the tidal volume will be decreased.

ASV mode is expected to be safe, assessed by adequate inspiratory transpulmonary pressures, and expected to be as effective as VC mode with lower intrinsic positive end expiratory pressure (iPEEP) levels.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Restrictive lung pathologies

• Impaired hemodynamic status

• Esophageal pathologies

• Bronchopleural fistula

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Minute volume target of 100%
Patients will be ventilated to reach minute volume target of %100 (100 ml per ideal body weight).
• Minute volume target to reach PaCO2 less than 45% (high tidal volume)
Patients will be ventilated to reach minute volume target associated with PaCO2 less than 45%.

Locations

Country	Name	City	State
Turkey	Izmir Dr. Suat Seren Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit	Izmir	Yenisehir

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean arterial pressure	Mean arterial pressure measured by invasive or non-invasive methods	30'th minute of each intervention arm
Other	PaO2, FiO2 ratio	Ratio of arterial partial oxygen pressure to inspired fraction of oxygen	30'th minute of each intervention arm
Other	Heart rate	Heart rate measured by ECG	30'th minute of each intervention arm
Primary	Transpulmonary inspiratory pressure (Ptinsp)	Ptpinsp will be measured with an inspiratory pause maneuver.	30'th minute of each intervention arm
Secondary	Intrinsic Positive End Expiratory Pressure (PEEPi)	PEEPi will be measured with an expiratory hold maneuver.	30'th minute of each intervention arm