ARDS Clinical Trial
— AVACOfficial 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
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Malaya |
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
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 |
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