Assessing Ventilator Safety in Patients on Pressure-Support Ventilation

Acute Respiratory Failure Clinical Trial

— ASOP  

Official title:

Assessing Ventilator Safety in Patients on Pressure-Support Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05125952
• Other study ID #: Pro00106860
• Status: Completed
• Phase: N/A
• Start date: February 8, 2022
• Est. completion date: December 21, 2023

Study information

• Verified date: November 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

ASOP is a prospective cohort study comparing three methods for assessing risk of self-induced lung injury in patients with acute respiratory failure being managed with pressure-support ventilation. We will describe the relationship between three different assessment methods for risk of self-induced lung injury and compare them to a gold standard measurement.

Description:

Ventilator-induced lung injury (VILI) is known to cause significant morbidity and mortality in patients with acute respiratory failure. Most studies on VILI have involved the effects of inappropriate (often excessive) mechanical ventilator settings. More recently, it has been noted that similar lung damage can be caused by large, patient generated, uncontrolled tidal volumes and driving pressures, which has been termed "self-induced lung injury," or SILI.

Pressure-support ventilation (PSV) is a common mechanical ventilation mode often used in patients with active inspiratory efforts to help reduce patient inspiratory work and improve comfort. PSV effectively allows spontaneously breathing patients to determine their breath flow-rate and breath duration, eliminating flow and cycle dyssynchrony. However, pressure support ventilation does not allow for physicians to control tidal volume or driving pressure. The risk of SILI may thus be increased with PSV.

Several different methods have been proposed to address these challenges. However, to date none of these methods have been compared to assess for concordance in their ability to indicate an increased risk of self-induced lung injury. ASOP is a prospective cohort study comparing three methods for assessing risk of self-induced lung injury in patients with acute respiratory failure being managed with pressure-support ventilation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 21, 2023
• Est. primary completion date: November 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients age =18 years with acute respiratory failure receiving invasive mechanical ventilation

• Managed in pressure-support mode of ventilation

Exclusion Criteria:

• Actively undergoing a spontaneously awakening trial or SAT

• Patient or surrogate is unable to provide informed consent

• Currently pregnant

• Currently incarcerated

• Acute exacerbation of an obstructive lung disease

• Known esophageal varices or any other condition for which the attending physician deems an orogastric catheter to be unsafe

• Esophageal, gastric or duodenal surgical procedures within the last 6 months

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Lung Injury
• Mechanical Ventilation Complication
• Respiratory Insufficiency
• Ventilator-Induced Lung Injury

Intervention

Device:
• Viasys Avea Ventilator
Measuring dynamic airway driving pressure and static airway driving pressure during pressure support breath, and static airway driving pressure during a volume control breath. Measuring airway occlusion pressure during pressure support breath.
• Philips Respironics NM3 device
Measuring static airway driving pressure during pressure support breath
• Servo U ventilator
Measuring static airway driving pressure and p0.1 during pressure support breath.
• Vyaire SmartCath adult nasogastric tube with Esophageal balloon
Measuring static and dynamic esophageal driving pressure during pressure support breath, and esophogeal pressure change during airway occlusion maneuver.

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (6)

Beitler JR, Malhotra A, Thompson BT. Ventilator-induced Lung Injury. Clin Chest Med. 2016 Dec;37(4):633-646. doi: 10.1016/j.ccm.2016.07.004. Epub 2016 Oct 14. — View Citation

Grieco DL, Menga LS, Eleuteri D, Antonelli M. Patient self-inflicted lung injury: implications for acute hypoxemic respiratory failure and ARDS patients on non-invasive support. Minerva Anestesiol. 2019 Sep;85(9):1014-1023. doi: 10.23736/S0375-9393.19.13418-9. Epub 2019 Mar 12. — View Citation

Hess DR. Ventilator waveforms and the physiology of pressure support ventilation. Respir Care. 2005 Feb;50(2):166-86; discussion 183-6. — 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

Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available. Erratum In: N Engl J Med. 2014 Apr 24;370(17):1668-9. — View Citation

Sottile PD, Albers D, Smith BJ, Moss MM. Ventilator dyssynchrony - Detection, pathophysiology, and clinical relevance: A Narrative review. Ann Thorac Med. 2020 Oct-Dec;15(4):190-198. doi: 10.4103/atm.ATM_63_20. Epub 2020 Oct 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory System Driving Pressure measure by Servo Ventilator (DPrs-servo)	Driving pressure in centimeters of water measured with inspiratory hold on Servo Ventilator in pressure-support ventilation.	Study day 1
Primary	Respiratory System Driving Pressure measure by Respironics NM3 device (DPrs-NM3)	Driving pressure in centimeters of water measured with Phillips Respironics NM3 device in pressure-support ventilation.	Study day 1
Primary	Airway Occlusion Test (AOC)	Maximum negative airway pressure in centimeters of water during an airway occlusion maneuver.	Study day 1
Primary	Respiratory System Driving Pressure measured during volume control breath.	Airway driving pressure in centimeters of water measured with inspiratory hold in volume control/assist control.	Study day 1
Primary	Transpulmonary Driving pressure measured during volume control breath.	Transpulmonary driving pressure in centimeters of water measured via esophageal balloon with inspiratory hold in volume control/assist control.	Study day 1
Secondary	Duration of mechanical ventilation	Number of days receiving mechanical ventilation	Index hospitalization (up to 28 days)
Secondary	Duration of intensive care unit admission	Number of days admitted to intensive care unit	Index hospitalization (up to 28 days)
Secondary	Duration of hospital admission	Number of days admitted to hospital	Index hospitalization (up to 28 days)
Secondary	Ventilator Free Days	Number of days free from mechanical ventilation	Index hospitalization (up to 28 days)
Secondary	In-hospital survival	Survival to discharge	Index hospitalization (up to 28 days)