Ventilator LungAVACNCT06157073
Efficacy and Safety of Automated Closed-loop Ventilator vs Conventional Open-loop Ventilator in the Emergency Department
A study testing Closed-loop ventilator and Open-loop ventilator in people with Ventilator Lung and Mechanical Ventilation Complication, run by University of Malaya.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Lung, Mechanical Ventilation Complication, Ventilator-Induced Lung Injury
- What is being tested?
- Closed-loop ventilator and Open-loop ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Decision made by treating physicians to intubate and mechanically ventilate
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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
- Being tested
- Closed-loop ventilator, Open-loop ventilator
- Keywords
- mechanical ventilation, closed loop ventilator, open loop ventilator, emergency department
- Medical subject headings
- Ventilator-Induced Lung Injury, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop ventilatorDevice
Fully automated closed-loop ventilator using the INTELLIVENT software
Open-loop ventilatorDevice
Conventional closed-loop ventilator with manual adjustments by the physician in charge
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Closed-loop ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Every 30 seconds for 240 minutes
Secondary outcomes (15)
Manual adjustments of ventilator settings
Frequency of manual adjustments of ventilator settings and the parameters requiring adjustments
Measured: Any time the manual adjustment is performed throughout the 4-hour study period
Physiological data - blood pressure
Patient's blood pressure in mmHg
Measured: Mean hourly for 4 hours
Physiological data - respiratory rate
Patient's respiratory rate in breaths per minute
Measured: Mean hourly for 4 hours
Physiological data - heart rate
Patient's heart rate in beats per minute
Measured: Mean hourly for 4 hours
Biochemical data - pH
Arterial pH levels
Measured: Upon intubation, at 1-hour, 2-hour, 3-hour and 4-hour
Biochemical data - CO2 and O2
Arterial partial pressure of carbon dioxide and oxygen in mmHg
Measured: Upon intubation, at 1-hour, 2-hour, 3-hour and 4-hour
Biochemical data - bicarbonate
Arterial bicarbonate levels in mmol/L
Measured: Upon intubation, at 1-hour, 2-hour, 3-hour and 4-hour
Patient outcome - mechanical ventilation
Duration of mechanical ventilation
Measured: Assessed from time of intubation to time of successful extubation or death from any cause, whichever came first, assessed up to 28 days
Patient outcome - LOS ED
Length of stay in emergency department
Measured: Assessed from time of triage to time patient leaves ED or death, whichever comes first, up to 7 days
Patient outcome - LOS ICU
Length of intensive care unit stay
Measured: Assessed from time of admission into the ICU to time of transfer to general ward or death, whichever comes first up to 28 days
Patient outcome - LOS hospital
Length of hospital stay
Measured: Assessed from time of triage in ED to time of discharge or in-hospital death, whichever comes first up to 28 days
Mortality rate
Number and percentage of deaths
Measured: At 14 and 28 days after recruitment
Number of patients developing ARDS and pneumothorax
Development of complications (pneumothorax, ARDS) during study and throughout admission
Measured: At anytime within the 4-hour intervention or upon discharge or diagnosis of complications
Ventilator data - airway pressures
Ventilator parameters: mean and peak airway pressures in cmH20
Measured: Every 30 seconds for 240 minutes
Ventilator data - FiO2
Ventilator parameters: fraction of inspired oxygen (FiO2)
Measured: Every 30 seconds for 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ventilator LungStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Khadijah Poh Yuen Yoong, University of Malaya
- Investigators
- Khadijah Poh, MMed, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157073
- Sponsor's protocol ID
- 2023317-12254
- Other IDs
- NMRR ID-23-03290-LRC
- Acronym
- AVAC
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data for this study will not be made publicly available. However, summary results and study outcomes will be transparently reported in the form of aggregated data and CSV files. This approach ensures that key findings are accessible while respecting participant confidentiality.
Publications
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.
PubMed 23338569Savioli 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.
PubMed 35207769Angotti 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.
PubMed 28874952Arnal 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.
PubMed 24025234Clavieras 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.
PubMed 23619172Chelly 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.
PubMed 32698860
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06157073
- Acronym / sponsor ID
- AVAC / 2023317-12254
- Conditions
- Ventilator Lung, Mechanical Ventilation Complication, Ventilator-Induced Lung Injury, ARDS
- Keywords
- mechanical ventilation, closed loop ventilator, open loop ventilator, emergency department
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Open-loop ventilator | Active comparator | Device: Open-loop ventilatorPrior 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. |
| Closed-loop ventilator | Experimental | Device: Closed-loop ventilatorPrior 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Decision made by treating physicians to intubate and mechanically ventilate
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed-loop ventilatorFully automated closed-loop ventilator using the INTELLIVENT software | Device | Closed-loop ventilator |
| Open-loop ventilatorConventional closed-loop ventilator with manual adjustments by the physician in charge | Device | Open-loop ventilator |
Primary outcome
Duration of ventilation within a predefined range of acceptable respiratory parameters
Time frame: Every 30 seconds for 240 minutes
Duration of ventilation (in minutes) within predefined acceptable tidal volume (TV), plateau pressure, EtCO2 and SpO2
15 secondary outcomes
Manual adjustments of ventilator settings
Time frame: Any time the manual adjustment is performed throughout the 4-hour study period
Physiological data - blood pressure
Time frame: Mean hourly for 4 hours
Physiological data - respiratory rate
Time frame: Mean hourly for 4 hours
Physiological data - heart rate
Time frame: Mean hourly for 4 hours
Biochemical data - pH
Time frame: Upon intubation, at 1-hour, 2-hour, 3-hour and 4-hour
Biochemical data - CO2 and O2
Time frame: Upon intubation, at 1-hour, 2-hour, 3-hour and 4-hour
Biochemical data - bicarbonate
Time frame: Upon intubation, at 1-hour, 2-hour, 3-hour and 4-hour
Patient outcome - mechanical ventilation
Time frame: Assessed from time of intubation to time of successful extubation or death from any cause, whichever came first, assessed up to 28 days
Patient outcome - LOS ED
Time frame: Assessed from time of triage to time patient leaves ED or death, whichever comes first, up to 7 days
Patient outcome - LOS ICU
Time frame: Assessed from time of admission into the ICU to time of transfer to general ward or death, whichever comes first up to 28 days
Patient outcome - LOS hospital
Time frame: Assessed from time of triage in ED to time of discharge or in-hospital death, whichever comes first up to 28 days
Mortality rate
Time frame: At 14 and 28 days after recruitment
Number of patients developing ARDS and pneumothorax
Time frame: At anytime within the 4-hour intervention or upon discharge or diagnosis of complications
Ventilator data - airway pressures
Time frame: Every 30 seconds for 240 minutes
Ventilator data - FiO2
Time frame: Every 30 seconds for 240 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 23338569Lellouche 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.
- Background: PubMed 35207769Savioli 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.
- Background: PubMed 28874952Angotti 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.
- Background: PubMed 24025234Arnal 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.
- Background: PubMed 23619172Clavieras 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.
- Background: PubMed 32698860Chelly 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.
- Individual participant dataSharing planned: No. Individual participant data for this study will not be made publicly available. However, summary results and study outcomes will be transparently reported in the form of aggregated data and CSV files. This approach ensures that key findings are accessible while respecting participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khadijah Poh, MMed principal investigator
University of Malaya
Questions about this trial
What is this clinical trial studying?
A study testing Closed-loop ventilator and Open-loop ventilator in people with Ventilator Lung and Mechanical Ventilation Complication, run by University of Malaya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Muhaimin, MMed (+60173600157, muhaimin@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of ventilation within a predefined range of acceptable respiratory parameters (time frame: Every 30 seconds for 240 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06157073, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.