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

NCT06157073 | Unknown

• 2 other identifiers: 2023317-12254NMRR ID-23-03290-LRC
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ventilator Lung; Mechanical Ventilation Complication; Ventilator-Induced Lung Injury; ARDS

Keywords

mechanical ventilation; closed loop ventilator; open loop ventilator; emergency department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Manual adjustments of ventilator settings

  Any time the manual adjustment is performed throughout the 4-hour study period

• Physiological data - blood pressure

  Mean hourly for 4 hours

• Physiological data - respiratory rate

  Mean hourly for 4 hours

• Physiological data - heart rate

  Mean hourly for 4 hours

• Biochemical data - pH

  Upon intubation, at 1-hour, 2-hour, 3-hour and 4-hour

Study Arms (2)

Open-loop ventilator

ACTIVE COMPARATOR

Prior to the rapid sequence intubation, patients' gender and height are set on the ventilator. The physician in-charge will setup the ventilator based on the lung condition, following the research protocol. Patients will be connected to this ventilator upon securing the airway. Ventilator setting parameters will be manually adjusted by the in-charge physician following local guidelines.

Device: Open-loop ventilator

Closed-loop ventilator

EXPERIMENTAL

Prior to the rapid sequence intubation, patients' gender and height are set on the ventilator. Patients' condition settings are selected depending on the lung condition. The sensors for end-tidal carbon dioxide (EtCO2) and oxygen saturation (SpO2) will be connected. Patients will be connected to this ventilator upon securing the airway. Ventilator setting parameters will be set following the study protocol.

Device: Closed-loop ventilator

Interventions

Closed-loop ventilator DEVICE

Fully automated closed-loop ventilator using the INTELLIVENT software

Closed-loop ventilator

Open-loop ventilator DEVICE

Conventional closed-loop ventilator with manual adjustments by the physician in charge

Open-loop ventilator

Eligibility Criteria

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

You may qualify if:

• Decision made by treating physicians to intubate and mechanically ventilate

You may not qualify if:

• Suspected or confirmed pregnancy.
• Known right ventricular heart failure upon assessment for recruitment.
• Severe metabolic acidosis upon intubation (pH \<7.2 or bicarbonate \<12 mmol/L)
• Circulatory shock requiring noradrenaline more than 0.5 mcg/kg/min upon assessment for recruitment.
• Severe or acute life-threatening asthma.
• Patients with chest wall deformities that would affect ventilation (e.g. severe kyphoscoliosis, diaphragmatic hernia, flail chest, trauma, pectus excavatum or carinatum, ankylosing spondylitis
• Patients with previous lobectomy or pneumonectomy.
• Patients with pneumothorax or other condition that requires chest drainage tube.
• Patients with body mass index \> 40 kg/m2.
• 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.
• Participation in another interventional trial.
• Do-not-attempt-resuscitation (DNAR) order.

Sponsors & Collaborators

• University of Malaya: lead

Related Publications (6)

• 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.

  PMID: 23338569 BACKGROUND

• 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.

  PMID: 35207769 BACKGROUND

• 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.

  PMID: 28874952 BACKGROUND

• 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.

  PMID: 24025234 BACKGROUND

• 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.

  PMID: 23619172 BACKGROUND

• 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.

  PMID: 32698860 BACKGROUND

MeSH Terms

Conditions

Ventilator-Induced Lung Injury; Emergencies

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Khadijah Poh, MMed

  University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Muhaimin, MMed

CONTACT

+60173600157; muhaimin@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Emergency Physician

Model Details: Subjects who meet all criteria for enrolment will be randomized in a 1:1 allocation ratio to receive either open-loop ventilator (OLV) or closed-loop ventilator (CLV). Randomization will be stratified by the respiratory pathology present: normal lung, hypercapnic respiratory failure and decreased lung compliance. Randomization sequence will be generated using a web-based randomisation software.

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: December 5, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share