Postoperative INTELLiVENT-ASV Ventilation

NCT03180203 | Completed

• 1 other identifier: NL58975.100.16
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilators, Mechanical; Intensive Care Units; Postoperative Care

Keywords

INTELLiVENT-ASV; Fully closed-loop ventilation; Wean

Outcome Measures

Primary Outcomes (1)

• 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%.

  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.

  During the first 24, 48 and 72 hours after extubation

• Postoperative weaning time

  72 hours

• Workload

  72 hours

• Usability

  Up to 1 day after extubation

• Patient agitation

  Up to 72 hours of mechanical ventilation time

Study Arms (2)

INTELLiVENT-ASV

EXPERIMENTAL

INTELLiVENT-ASV is a full closed-loop ventilation mode,available on the mechanical ventilator S1 of Hamilton.

Device: INTELLiVENT-ASV

Conventional modes

ACTIVE COMPARATOR

Volume controlled continuous mandatory ventilation (CMV) mode with pressure support mode on the Hamilton S1 Device.

Device: Conventional modes

Interventions

INTELLiVENT-ASV DEVICE

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.

INTELLiVENT-ASV

Conventional modes DEVICE

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.

Conventional modes

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (1)

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 24577110 BACKGROUND

• 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

• De 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.

  PMID: 32739044 DERIVED

Study Officials

• Ashley De Bie Dekker, Msc

  Catharina Ziekenhuis Eindhoven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc.

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 8, 2017
• Study Start: May 22, 2017
• Primary Completion: May 1, 2018
• Study Completion: June 27, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)