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Trial record 2 of 53 for:    mechanical ventilators AND mode | Recruiting, Not yet recruiting, Available Studies

Postoperative INTELLiVENT-ASV Ventilation. (POSITiVE)

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ClinicalTrials.gov Identifier: NCT03180203
Recruitment Status : Recruiting
First Posted : June 8, 2017
Last Update Posted : June 8, 2017
Sponsor:
Collaborator:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
Ashley De Bie, Catharina Ziekenhuis Eindhoven

Brief 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.

Condition or disease Intervention/treatment Phase
Ventilators, Mechanical Intensive Care Units Postoperative Care Device: INTELLiVENT-ASV Device: Conventional modes Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:

The participant will not know which ventilation mode will be or is used. The primairy investigator and care providers are aware of which ventilation mode is used since it is not possible to blind the care providers because they will need to change ventilating parameters if necessary.

The outcome assesor for the percentages of time will be masked. Also are the radiologists, who judge the postoperative thoracic x-ray, masked.

Primary Purpose: Treatment
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.
Actual Study Start Date : May 22, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : June 30, 2018

Arm Intervention/treatment
Experimental: INTELLiVENT-ASV
INTELLiVENT-ASV is a full closed-loop ventilation mode,available on the mechanical ventilator S1 of Hamilton.
Device: INTELLiVENT-ASV

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.


Active Comparator: Conventional modes
Volume controlled continuous mandatory ventilation (CMV) mode with pressure support mode on the Hamilton S1 Device.
Device: Conventional modes

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.





Primary Outcome Measures :
  1. 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%.


Secondary Outcome Measures :
  1. The percentage (%) of successful extubations. [ Time Frame: During the first 24, 48 and 72 hours after extubation ]
    A successful extubation is an extubation without a new intubation or the use of non-invasive ventilation within 24, 48 or 72 hours.

  2. Postoperative weaning time [ Time Frame: 72 hours ]
    The time from admission on the ICU and a temperature of >35.5°C until extubation.

  3. Workload [ Time Frame: 72 hours ]
    The number of alarms and required interactions between the ventilator and the user during mechanical ventilation on the ICU.

  4. Usability [ Time Frame: Up to 1 day after extubation ]
    A survey with acceptance score (1-10) completed by the care provider at the bedside who treated the patient for the weaning

  5. Patient agitation [ Time Frame: Up to 72 hours of mechanical ventilation time ]
    The number of agitated moments of the patient recognized by the ICU care provider at the bedside.

  6. Administration of sedatives and analgesics [ Time Frame: Up to 72 hours of mechanical ventilation time ]
    The number and dosages of administrations of NSAIDs, opiates, benzodiazepines, clonidine, propofol or haloperidol during mechanical ventilation.

  7. The Richmond Agitation-Sedation Scale (RASS) [ Time Frame: Up to 72 hours of mechanical ventilation time ]
    The RASS for every hour during mechanical ventilation.

  8. Postoperative atelectasis [ Time Frame: Up to 48 hours after extubation ]
    The number of a patients with an atelectasis on the first thoracic x-ray or the thoracic x-ray the following day after surgery.

  9. CO2 levels for postoperative pulmonary shunting [ Time Frame: Up to 72 hours of mechanical ventilation time ]
    The EtCO2/pCO2 ratio during mechanical ventilation.

  10. O2 levels for postoperative pulmonary shunting [ Time Frame: Up to 72 hours of mechanical ventilation time ]
    The pO2/FiO2 ratio during mechanical ventilation.

  11. Reliability of non-invasive oxygen saturation measurement [ Time Frame: 72 hours ]
    The time of mechanical ventilation on the ICU without non-invasive measurement of the oxygen saturation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180203


Contacts
Contact: Ashley De Bie Dekker, Msc 0031402399111 ashleydebiedekker@gmail.com
Contact: Alex Bindels, Dr. 0031402399111 alex.bindels@catharinaziekenhuis.nl

Locations
Netherlands
Catharina Hospital Recruiting
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
Contact: Ashley De Bie Dekker, MD.    0031402395076    ashley.d.bie@catharinaziekenhuis.nl   
Contact: Alexander Bindels, Dr.    0031402399111    alex.bindels@catharinaziekenhuis.nl   
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Principal Investigator: Ashley De Bie Dekker, Msc Catharina Ziekenhuis Eindhoven

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: Study Intensive Care
Contact can be made to request the study protocol (Dutch)

Publications:
Responsible Party: Ashley De Bie, MSc., Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT03180203     History of Changes
Other Study ID Numbers: NL58975.100.16
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ashley De Bie, Catharina Ziekenhuis Eindhoven:
INTELLiVENT-ASV
Fully closed-loop ventilation
Wean