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

NCT ID: NCT06157073

Last Updated: 2023-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-12-31

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.

Detailed 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.

Conditions

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

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Open-loop ventilator

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.

Group Type: ACTIVE_COMPARATOR

Open-loop ventilator

Intervention Type: DEVICE

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

Closed-loop ventilator

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.

Group Type: EXPERIMENTAL

Closed-loop ventilator

Intervention Type: DEVICE

Fully automated closed-loop ventilator using the INTELLIVENT software

Interventions

Closed-loop ventilator

Fully automated closed-loop ventilator using the INTELLIVENT software

Intervention Type: DEVICE

Open-loop ventilator

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Dr. Khadijah Poh Yuen Yoong

Consultant Emergency Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khadijah Poh, MMed

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Central Contacts

Dr Muhaimin, MMed

Role: CONTACT

Phone: +60173600157

Email: muhaimin@um.edu.my

References

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.

Reference Type: BACKGROUND

PMID: 23338569 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35207769 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28874952 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24025234 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23619172 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32698860 (View on PubMed)

Other Identifiers

NMRR ID-23-03290-LRC

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023317-12254

Identifier Type: -

Identifier Source: org_study_id