Postoperative INTELLiVENT-ASV Ventilation (POSITiVE)

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Care; Intensive Care Units; Ventilators, Mechanical
• Intervention / Treatment: Device: INTELLiVENT-ASV; Device: Conventional modes

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
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Brabant
    • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
      • Catharina hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	72 hours
Workload	The number of alarms and required interactions between the ventilator and the user during mechanical ventilation on the ICU.	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	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.	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.	Up to 72 hours of mechanical ventilation time
The Richmond Agitation-Sedation Scale (RASS)	The RASS for every hour during mechanical ventilation.	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.	Up to 48 hours after extubation
CO2 levels for postoperative pulmonary shunting	The EtCO2/pCO2 ratio during mechanical ventilation.	Up to 72 hours of mechanical ventilation time
O2 levels for postoperative pulmonary shunting	The pO2/FiO2 ratio during mechanical ventilation.	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.	72 hours

Collaborators and Investigators

• Sponsor: Catharina Ziekenhuis Eindhoven
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Ashley De Bie Dekker, Msc, Catharina Ziekenhuis Eindhoven

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2017
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): June 27, 2018

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 8, 2017

Study Record Updates

• Last Update Posted (Actual): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: INTELLiVENT-ASV; Fully closed-loop ventilation; Wean
• Other Study ID Numbers: NL58975.100.16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Study Data/Documents

1. Study Protocol
   Information identifier: Study Intensive Care
   Information comments: Contact can be made to request the study protocol (Dutch)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No