Ventilators, MechanicalPOSITiVENCT03180203
Postoperative INTELLiVENT-ASV Ventilation
A study testing INTELLiVENT-ASV and Conventional modes in people with Ventilators, Mechanical and Intensive Care Units, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
The aim of this study is to investigate whether postoperative ventilation with INTELLiVENT-ASV(adaptive support ventilation) in high risk patients, after cardiothoracic surgery, is as effective, more user-friendly and as safe as compared to the conventional modes of ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilators, Mechanical, Intensive Care Units, Postoperative Care
- What is being tested?
- INTELLiVENT-ASV and Conventional modes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 May 2017to 27 Jun 2018
- 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
- Age above 18 years of age.
- Informed consent.
- Body mass index of <35 kg/m2.
- Mechanical ventilation after elective cardiothoracic surgery.
- Admission of the patient after surgery is on the high care unit of the intensive care ward for postoperative mechanical ventilation.
Who cannot join
- Withdrawal of consent
- Medical history of a pneumonectomy or lobectomy.
- The patient wit acute respiratory distress syndrome after surgery.
- The patient with a medical history of COPD Gold 3 or 4.
- The patient is participating in another postoperative study performed on the intensive care.
- The patient is, preoperatively determined, eligible for a fast-track postoperative treatment program on the Post Anesthesia Care Unit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Full Closed Loop Ventilation Mode INTELLiVENT-ASV: User-friendly and Effective Mechanical Ventilation in High Risk Postoperative Patient on the Intensive Care Unit
The aim of this study is to investigate whether postoperative ventilation with INTELLiVENT-ASV(adaptive support ventilation) in high risk patients, after cardiothoracic surgery, is as effective, more user-friendly and as safe as compared to the conventional modes of ventilation.
Read the detailed description
Recently, Hamilton Medical has introduced the new mechanical ventilation mode "INTELLiVENT-ASV". This is a fully closed ventilation mode that can automatically adjust the ventilation settings based on the measured End tidal CO2 (ETCO2) and the measured saturation (SpO2) in both passive and active ventilated patients. Current literature has shown that this mode is safe to use in patients admitted on the intensive care unit. A pilot study in the Catharina Hospital Eindhoven confirmed that in postoperative low risk patients on the intensive care unit INTELLiVENT-ASV is safe. Compared to continuous mandatory or pressure controlled ventilation with pressure support (conventional mechanical ventilation), INTELLiVENT-ASV is even as effective as conventional mechanical ventilation, with a significantly reduced number of interactions with the ventilator. However, available research about the effectiveness of INTELLiVENT-ASV in postoperative high risk patients is lacking. Also the knowledge about the user-friendliness of the above modes of mechanical ventilation for the users is lacking.
This is a prospective randomized study with a control group and a intervention group of postoperative high risk patients. Through randomization will be determined whether the participant, after surgery, will be mechanically ventilated with INTELLiVENT-ASV and Quickwean or with conventional mechanical ventilation.
- Being tested
- INTELLiVENT-ASV, Conventional modes
- Keywords
- INTELLiVENT-ASV, Fully closed-loop ventilation, Wean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTELLiVENT-ASVDevice
After ICU admission:
- The first three hours: only ventilation with INTELLiVENT-ASV with Quickwean.
- After three hours: Automatic spontaneous breathing trials (SBT) is activated and SBT starts if >10minutes PEEP:<9cmH2O,FiO2:<41%,VT/IBW<5ml/kg and RSB:<106l/l*min.
Settings SBT are MV% 25%,PEEP 5cmH2O.SBT automatically stops if respiratory rate >35b/min or increases >100% since start of SBT, FiO2 >50%, PeTCO2 increases >8mmHg.
Extubation criteria: Leakage <50ml/hr,hemodynamically stable, awake with enough muscle strength and successful SBT >10min.
If during mechanical ventilation the ICU care providers decide that it is necessary for the treatment, they may switch to another ventilation mode or extubate without a SBT.
Conventional modesDevice
After ICU admission:
The first three hours: only ventilation with CMV or PS. If required care providers may change the mode to adaptive support ventilation.
After three hours: manual SBT is required if >10min PS<11cmH2O,PEEP<9cmH2O,FiO2<41%.
Settings SBT are PS 5cmH2O, PEEP 5cmH2O, FiO2 30%. SBT must be stopped if respiratory rate >35b/min or increases >100% since the start of SBT, saturation <92% or the PeTCO2 increases >8mmHg.
Extubation criteria: Leakage <50ml/hr,hemodynamically stable, awake with enough muscle strength and successful SBT >10min.
If during mechanical ventilation the ICU care providers decide that it is necessary for the treatment, they may switch to another ventilation mode or extubate without a SBT.
| Study group | Role | What they receive |
|---|---|---|
| INTELLiVENT-ASV | Experimental | INTELLiVENT-ASV is a full closed-loop ventilation mode,available on the mechanical ventilator S1 of Hamilton. Receives: Device: INTELLiVENT-ASV |
| Conventional modes | Active comparator | Volume controlled continuous mandatory ventilation (CMV) mode with pressure support mode on the Hamilton S1 Device. Receives: Device: Conventional modes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage (%) of mechanical ventilation time in an optimal, acceptable or unacceptable ventilation zone.
- An optimal zone = Tidal volume (TV) = 4-8 ml/kg of the predicted body weight (PBW) with an EtCO2 = 30-45mmHg, a plateau pressure = <31cmH2O and SpO2 = 93-98%.
- An acceptable zone = TV = 8-12 ml/kg of PBW with an EtCO2 = 25-30 or 45-50mmHg, a plateau pressure = 31-35 cmH2O and SpO2 = 85-93% or >98%.
- An unacceptable zone = TV >12 ml/kg of PBW or an EtCO2 = <25 or >50mmHg, plateau pressure >35 cmH2O or SpO2 = <85%.
Measured: During the first 3 hours, since admission on the ICU with the start of the intervention ventilation mode.
Secondary outcomes (11)
The percentage (%) of successful extubations.
A successful extubation is an extubation without a new intubation or the use of non-invasive ventilation within 24, 48 or 72 hours.
Measured: During the first 24, 48 and 72 hours after extubation
Postoperative weaning time
The time from admission on the ICU and a temperature of >35.5°C until extubation.
Measured: 72 hours
Workload
The number of alarms and required interactions between the ventilator and the user during mechanical ventilation on the ICU.
Measured: 72 hours
Usability
A survey with acceptance score (1-10) completed by the care provider at the bedside who treated the patient for the weaning
Measured: Up to 1 day after extubation
Patient agitation
The number of agitated moments of the patient recognized by the ICU care provider at the bedside.
Measured: Up to 72 hours of mechanical ventilation time
Administration of sedatives and analgesics
The number and dosages of administrations of NSAIDs, opiates, benzodiazepines, clonidine, propofol or haloperidol during mechanical ventilation.
Measured: Up to 72 hours of mechanical ventilation time
The Richmond Agitation-Sedation Scale (RASS)
The RASS for every hour during mechanical ventilation.
Measured: Up to 72 hours of mechanical ventilation time
Postoperative atelectasis
The number of a patients with an atelectasis on the first thoracic x-ray or the thoracic x-ray the following day after surgery.
Measured: Up to 48 hours after extubation
CO2 levels for postoperative pulmonary shunting
The EtCO2/pCO2 ratio during mechanical ventilation.
Measured: Up to 72 hours of mechanical ventilation time
O2 levels for postoperative pulmonary shunting
The pO2/FiO2 ratio during mechanical ventilation.
Measured: Up to 72 hours of mechanical ventilation time
Reliability of non-invasive oxygen saturation measurement
The time of mechanical ventilation on the ICU without non-invasive measurement of the oxygen saturation.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start22 May 2017
- Primary completion1 May 2018
- Study completion27 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ventilators, MechanicalStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Responsible party
- Principal investigator, Ashley De Bie, Catharina Ziekenhuis Eindhoven
- Investigators
- Ashley De Bie Dekker, Msc, Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180203
- Sponsor's protocol ID
- NL58975.100.16
- Acronym
- POSITiVE
- Status last verified
- Nov 2018
- First submitted
- 30 May 2017
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beijers AJ, Roos AN, Bindels AJ. Fully automated closed-loop ventilation is safe and effective in post-cardiac surgery patients. Intensive Care Med. 2014 May;40(5):752-3. doi: 10.1007/s00134-014-3234-7. Epub 2014 Feb 28. No abstract available.
PubMed 24577110Lellouche 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 23338569De Bie AJR, Neto AS, van Meenen DM, Bouwman AR, Roos AN, Lameijer JR, Korsten EHM, Schultz MJ, Bindels AJGH. Fully automated postoperative ventilation in cardiac surgery patients: a randomised clinical trial. Br J Anaesth. 2020 Nov;125(5):739-749. doi: 10.1016/j.bja.2020.06.037. Epub 2020 Jul 30.
PubMed 32739044
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Full Closed Loop Ventilation Mode INTELLiVENT-ASV: User-friendly and Effective Mechanical Ventilation in High Risk Postoperative Patient on the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03180203
- Acronym / sponsor ID
- POSITiVE / NL58975.100.16
- Keywords
- INTELLiVENT-ASV, Fully closed-loop ventilation, Wean
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 22 May 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 27 Jun 2018 (actual)
- First posted
- 8 Jun 2017 (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.
The aim of this study is to investigate whether postoperative ventilation with INTELLiVENT-ASV(adaptive support ventilation) in high risk patients, after cardiothoracic surgery, is as effective, more user-friendly and as safe as compared to the conventional modes of ventilation.
Detailed description
Recently, Hamilton Medical has introduced the new mechanical ventilation mode "INTELLiVENT-ASV". This is a fully closed ventilation mode that can automatically adjust the ventilation settings based on the measured End tidal CO2 (ETCO2) and the measured saturation (SpO2) in both passive and active ventilated patients. Current literature has shown that this mode is safe to use in patients admitted on the intensive care unit. A pilot study in the Catharina Hospital Eindhoven confirmed that in postoperative low risk patients on the intensive care unit INTELLiVENT-ASV is safe. Compared to continuous mandatory or pressure controlled ventilation with pressure support (conventional mechanical ventilation), INTELLiVENT-ASV is even as effective as conventional mechanical ventilation, with a significantly reduced number of interactions with the ventilator. However, available research about the effectiveness of INTELLiVENT-ASV in postoperative high risk patients is lacking. Also the knowledge about the user-friendliness of the above modes of mechanical ventilation for the users is lacking.
This is a prospective randomized study with a control group and a intervention group of postoperative high risk patients. Through randomization will be determined whether the participant, after surgery, will be mechanically ventilated with INTELLiVENT-ASV and Quickwean or with conventional mechanical ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTELLiVENT-ASV | Experimental | Device: INTELLiVENT-ASVINTELLiVENT-ASV is a full closed-loop ventilation mode,available on the mechanical ventilator S1 of Hamilton. |
| Conventional modes | Active comparator | Device: Conventional modesVolume controlled continuous mandatory ventilation (CMV) mode with pressure support mode on the Hamilton S1 Device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age above 18 years of age.
- Informed consent.
- Body mass index of <35 kg/m2.
- Mechanical ventilation after elective cardiothoracic surgery.
- Admission of the patient after surgery is on the high care unit of the intensive care ward for postoperative mechanical ventilation.
Key exclusion criteria (6 listed)
- Withdrawal of consent
- Medical history of a pneumonectomy or lobectomy.
- The patient wit acute respiratory distress syndrome after surgery.
- The patient with a medical history of COPD Gold 3 or 4.
- The patient is participating in another postoperative study performed on the intensive care.
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 |
|---|---|---|
| INTELLiVENT-ASVAfter ICU admission: * The first three hours: only ventilation with INTELLiVENT-ASV with Quickwean. * After three hours: Automatic spontaneous breathing trials (SBT) is activated and SBT starts if >10minutes PEEP:<9cmH2O,FiO2:<41%,VT/IBW<5ml/kg and RSB:<106l/l*min. Settings SBT are MV% 25%,PEEP 5cmH2O.SBT automatically stops if respiratory rate >35b/min or increases >100% since start of SBT, FiO2 >50%, PeTCO2 increases >8mmHg. Extubation criteria: Leakage <50ml/hr,hemodynamically stable, awake with enough muscle strength and successful SBT >10min. If during mechanical ventilation the ICU care providers decide that it is necessary for the treatment, they may switch to another ventilation mode or extubate without a SBT. | Device | INTELLiVENT-ASV |
| Conventional modesAfter ICU admission: The first three hours: only ventilation with CMV or PS. If required care providers may change the mode to adaptive support ventilation. After three hours: manual SBT is required if >10min PS<11cmH2O,PEEP<9cmH2O,FiO2<41%. Settings SBT are PS 5cmH2O, PEEP 5cmH2O, FiO2 30%. SBT must be stopped if respiratory rate >35b/min or increases >100% since the start of SBT, saturation <92% or the PeTCO2 increases >8mmHg. Extubation criteria: Leakage <50ml/hr,hemodynamically stable, awake with enough muscle strength and successful SBT >10min. If during mechanical ventilation the ICU care providers decide that it is necessary for the treatment, they may switch to another ventilation mode or extubate without a SBT. | Device | Conventional modes |
Primary outcome
Percentage (%) of mechanical ventilation time in an optimal, acceptable or unacceptable ventilation zone.
Time frame: During the first 3 hours, since admission on the ICU with the start of the intervention ventilation mode.
* An optimal zone = Tidal volume (TV) = 4-8 ml/kg of the predicted body weight (PBW) with an EtCO2 = 30-45mmHg, a plateau pressure = <31cmH2O and SpO2 = 93-98%. * An acceptable zone = TV = 8-12 ml/kg of PBW with an EtCO2 = 25-30 or 45-50mmHg, a plateau pressure = 31-35 cmH2O and SpO2 = 85-93% or >98%. * An unacceptable zone = TV >12 ml/kg of PBW or an EtCO2 = <25 or >50mmHg, plateau pressure >35 cmH2O or SpO2 = <85%.
11 secondary outcomes
The percentage (%) of successful extubations.
Time frame: During the first 24, 48 and 72 hours after extubation
Postoperative weaning time
Time frame: 72 hours
Workload
Time frame: 72 hours
Usability
Time frame: Up to 1 day after extubation
Patient agitation
Time frame: Up to 72 hours of mechanical ventilation time
Administration of sedatives and analgesics
Time frame: Up to 72 hours of mechanical ventilation time
The Richmond Agitation-Sedation Scale (RASS)
Time frame: Up to 72 hours of mechanical ventilation time
Postoperative atelectasis
Time frame: Up to 48 hours after extubation
CO2 levels for postoperative pulmonary shunting
Time frame: Up to 72 hours of mechanical ventilation time
O2 levels for postoperative pulmonary shunting
Time frame: Up to 72 hours of mechanical ventilation time
Reliability of non-invasive oxygen saturation measurement
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Background: PubMed 24577110Beijers AJ, Roos AN, Bindels AJ. Fully automated closed-loop ventilation is safe and effective in post-cardiac surgery patients. Intensive Care Med. 2014 May;40(5):752-3. doi: 10.1007/s00134-014-3234-7. Epub 2014 Feb 28. No abstract available.
- 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.
- Derived from this study: PubMed 32739044De Bie AJR, Neto AS, van Meenen DM, Bouwman AR, Roos AN, Lameijer JR, Korsten EHM, Schultz MJ, Bindels AJGH. Fully automated postoperative ventilation in cardiac surgery patients: a randomised clinical trial. Br J Anaesth. 2020 Nov;125(5):739-749. doi: 10.1016/j.bja.2020.06.037. Epub 2020 Jul 30.
- Individual participant dataSharing planned: No
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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.
Ashley De Bie Dekker, Msc principal investigator
Catharina Ziekenhuis Eindhoven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTELLiVENT-ASV and Conventional modes in people with Ventilators, Mechanical and Intensive Care Units, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage (%) of mechanical ventilation time in an optimal, acceptable or unacceptable ventilation zone. (time frame: During the first 3 hours, since admission on the ICU with the start of the intervention ventilation mode.). 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 NCT03180203, which also lists 3 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 29 Nov 2018.