Efficacy and Safety of Automated Closed-loop Ventilator vs Conventional Open-loop Ventilator in the Emergency Department

ARDS Clinical Trial

— AVAC  

Official title:

A Randomized, Controlled Trial to Evaluate the Efficacy and Safety of Fully Automated Closed-loop Ventilator Versus Conventional Open-loop Ventilator in Ventilated Patients in the Emergency Department

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06157073
• Other study ID #: 2023317-12254
• Secondary ID: NMRR ID-23-03290
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: University of Malaya
• Contact: Dr Muhaimin, MMed
• Phone: +60173600157
• Email: muhaimin[@]um.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients presenting to the emergency department (ED) may require breathing support with machines depending on the condition. Throughout the breathing support, the settings on the breathing machines will be tailored to the patient's requirements. These settings are manually adjusted by trained physicians. Currently, there are machines which can automatically change the settings based on real-time specific information obtained from the patient. This study aims to compare the use of machines which require manual adjustments (open-loop conventional ventilators) and machines which can automatically change the settings (closed-loop automated ventilators). Patients will be carefully selected to ensure no harm is caused whilst delivering the best care. This study will look into the duration when patients are receiving optimum settings and levels of oxygen and carbon dioxide in the blood. The outcomes of this study would allow us to identify methods to improve patient care.

Description:

Invasive mechanical ventilation is a lifesaving intervention for patients with respiratory failure in the emergency department (ED). Recent technological advancements have introduced closed-loop automated ventilators as a potential alternative to open-loop conventional ventilators. However, the efficacy and safety of closed-loop automated ventilators in the emergency setting remains understudied. This research aims to evaluate the efficacy and safety of closed-loop automated ventilator compared to open-loop conventional ventilator in intubated and ventilated patients in the ED.

A randomized controlled trial will be conducted in an ED of a tertiary university-affiliated hospital. Eligible patients are 18 years or older, decision made by treating physicians to intubate and mechanically ventilate. Some of exclusion criteria are pregnancy, heart failure, metabolic acidosis, circulatory shock, life-threatening asthma and morbid obesity. The primary measure of efficacy is the duration of ventilation within a predefined range of acceptable respiratory parameters between automated and conventional ventilation. Secondary outcome measures are; number of manual adjustments required to attain targeted settings in automated and conventional ventilators, PaO2/FiO2 ratio (PF ratio), arterial blood gas results, vital signs, breath-by-breath analysis, and rate of ventilator dyssynchrony. The ventilator used in the intervention arm is the closed-loop automated ventilator Hamilton C6s INTELLIVENT-ASV (Hamilton Medical AG, Switzerland). Hamilton C1 ASV is chosen as the open-loop conventional comparator as it is similar to Hamilton C6s INTELLIVENT-ASV, without the INTELLIVENT software.

Based on Lellouche et al, the calculated total sample size with a dropout rate of 10% is 132. The data is analysed based on the intention-to-treat (ITT) and per-protocol (PP) principles. The primary endpoint measurements are reported as areas under the curves (AUC) within the predefined range of acceptable respiratory parameters. Between-group differences in continuous variables are analysed using independent t-test or Mann-Whitney U test. Between-group differences in categorical variables are analysed using chi-square test.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Decision made by treating physicians to intubate and mechanically ventilate

Exclusion Criteria:

1. Suspected or confirmed pregnancy.

2. Known right ventricular heart failure upon assessment for recruitment.

3. Severe metabolic acidosis upon intubation (pH <7.2 or bicarbonate <12 mmol/L)

4. Circulatory shock requiring noradrenaline more than 0.5 mcg/kg/min upon assessment for recruitment.

5. Severe or acute life-threatening asthma.

6. Patients with chest wall deformities that would affect ventilation (e.g. severe kyphoscoliosis, diaphragmatic hernia, flail chest, trauma, pectus excavatum or carinatum, ankylosing spondylitis

7. Patients with previous lobectomy or pneumonectomy.

8. Patients with pneumothorax or other condition that requires chest drainage tube.

9. Patients with body mass index > 40 kg/m2.

10. Manufacturer's contraindications:

• Difference in oxygen saturation between pulse oximetry (SpO2) and arterial sample (SaO2) of more than 5% (due to unreliable sensor).

• Difference in carbon dioxide level between end-tidal sensor (ETCO2) and arterial sample (PaCO2) of more than 5 mm Hg (due to unreliable sensor).

• Known pneumothorax and bronchopulmonary fistula upon assessment for recruitment.

11. Participation in another interventional trial.

12. Do-not-attempt-resuscitation (DNAR) order.

Related Conditions & MeSH terms

• ARDS
• Emergencies
• Lung Injury
• Mechanical Ventilation Complication
• Ventilator Lung
• Ventilator-Induced Lung Injury

Intervention

Device:
• Closed-loop ventilator
Fully automated closed-loop ventilator using the INTELLIVENT software
• Open-loop ventilator
Conventional closed-loop ventilator with manual adjustments by the physician in charge

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

References & Publications (6)

Angotti LB, Richards JB, Fisher DF, Sankoff JD, Seigel TA, Al Ashry HS, Wilcox SR. Duration of Mechanical Ventilation in the Emergency Department. West J Emerg Med. 2017 Aug;18(5):972-979. doi: 10.5811/westjem.2017.5.34099. Epub 2017 Jul 11. — View Citation

Arnal JM, Garnero A, Novonti D, Demory D, Ducros L, Berric A, Donati S, Corno G, Jaber S, Durand-Gasselin J. Feasibility study on full closed-loop control ventilation (IntelliVent-ASV) in ICU patients with acute respiratory failure: a prospective observational comparative study. Crit Care. 2013 Sep 11;17(5):R196. doi: 10.1186/cc12890. — View Citation

Chelly J, Mazerand S, Jochmans S, Weyer CM, Pourcine F, Ellrodt O, Thieulot-Rolin N, Serbource-Goguel J, Sy O, Vong LVP, Monchi M. Automated vs. conventional ventilation in the ICU: a randomized controlled crossover trial comparing blood oxygen saturation during daily nursing procedures (I-NURSING). Crit Care. 2020 Jul 22;24(1):453. doi: 10.1186/s13054-020-03155-3. — View Citation

Clavieras N, Wysocki M, Coisel Y, Galia F, Conseil M, Chanques G, Jung B, Arnal JM, Matecki S, Molinari N, Jaber S. Prospective randomized crossover study of a new closed-loop control system versus pressure support during weaning from mechanical ventilation. Anesthesiology. 2013 Sep;119(3):631-41. doi: 10.1097/ALN.0b013e3182952608. — View Citation

Lellouche F, Bouchard PA, Simard S, L'Her E, Wysocki M. Evaluation of fully automated ventilation: a randomized controlled study in post-cardiac surgery patients. Intensive Care Med. 2013 Mar;39(3):463-71. doi: 10.1007/s00134-012-2799-2. Epub 2013 Jan 22. — View Citation

Savioli G, Ceresa IF, Gri N, Bavestrello Piccini G, Longhitano Y, Zanza C, Piccioni A, Esposito C, Ricevuti G, Bressan MA. Emergency Department Overcrowding: Understanding the Factors to Find Corresponding Solutions. J Pers Med. 2022 Feb 14;12(2):279. doi: 10.3390/jpm12020279. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of ventilation within a predefined range of acceptable respiratory parameters	Duration of ventilation (in minutes) within predefined acceptable tidal volume (TV), plateau pressure, EtCO2 and SpO2	Every 30 seconds for 240 minutes
Secondary	Manual adjustments of ventilator settings	Frequency of manual adjustments of ventilator settings and the parameters requiring adjustments	Any time the manual adjustment is performed throughout the 4-hour study period
Secondary	Physiological data - blood pressure	Patient's blood pressure in mmHg	Mean hourly for 4 hours
Secondary	Physiological data - respiratory rate	Patient's respiratory rate in breaths per minute	Mean hourly for 4 hours
Secondary	Physiological data - heart rate	Patient's heart rate in beats per minute	Mean hourly for 4 hours
Secondary	Biochemical data - pH	Arterial pH levels	Upon intubation, at 1-hour, 2-hour, 3-hour and 4-hour
Secondary	Biochemical data - CO2 and O2	Arterial partial pressure of carbon dioxide and oxygen in mmHg	Upon intubation, at 1-hour, 2-hour, 3-hour and 4-hour
Secondary	Biochemical data - bicarbonate	Arterial bicarbonate levels in mmol/L	Upon intubation, at 1-hour, 2-hour, 3-hour and 4-hour
Secondary	Patient outcome - mechanical ventilation	Duration of mechanical ventilation	Assessed from time of intubation to time of successful extubation or death from any cause, whichever came first, assessed up to 28 days
Secondary	Patient outcome - LOS ED	Length of stay in emergency department	Assessed from time of triage to time patient leaves ED or death, whichever comes first, up to 7 days
Secondary	Patient outcome - LOS ICU	Length of intensive care unit stay	Assessed from time of admission into the ICU to time of transfer to general ward or death, whichever comes first up to 28 days
Secondary	Patient outcome - LOS hospital	Length of hospital stay	Assessed from time of triage in ED to time of discharge or in-hospital death, whichever comes first up to 28 days
Secondary	Mortality rate	Number and percentage of deaths	At 14 and 28 days after recruitment
Secondary	Number of patients developing ARDS and pneumothorax	Development of complications (pneumothorax, ARDS) during study and throughout admission	At anytime within the 4-hour intervention or upon discharge or diagnosis of complications
Secondary	Ventilator data - airway pressures	Ventilator parameters: mean and peak airway pressures in cmH20	Every 30 seconds for 240 minutes
Secondary	Ventilator data - FiO2	Ventilator parameters: fraction of inspired oxygen (FiO2)	Every 30 seconds for 240 minutes