Postoperative INTELLiVENT-ASV Ventilation

Intensive Care Units Clinical Trial

— POSITiVE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03180203
• Other study ID #: NL58975.100.16
• Status: Completed
• Phase: N/A
• Start date: May 22, 2017
• Est. completion date: June 27, 2018

Study information

• Verified date: November 2018
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 27, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intensive Care Units
• Postoperative Care
• Ventilators, Mechanical

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Catharina Hospital	Eindhoven	Noord-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Postoperative weaning time	The time from admission on the ICU and a temperature of >35.5°C until extubation.	72 hours
Secondary	Workload	The number of alarms and required interactions between the ventilator and the user during mechanical ventilation on the ICU.	72 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	The Richmond Agitation-Sedation Scale (RASS)	The RASS for every hour during mechanical ventilation.	Up to 72 hours of mechanical ventilation time
Secondary	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
Secondary	CO2 levels for postoperative pulmonary shunting	The EtCO2/pCO2 ratio during mechanical ventilation.	Up to 72 hours of mechanical ventilation time
Secondary	O2 levels for postoperative pulmonary shunting	The pO2/FiO2 ratio during mechanical ventilation.	Up to 72 hours of mechanical ventilation time
Secondary	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