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Postoperative INTELLiVENT-ASV Ventilation

NCT03180203 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2018-11-29

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • Catharina Ziekenhuis Eindhoven

    lead OTHER

Principal Investigators

  • Ashley De Bie Dekker, Msc · Catharina Ziekenhuis Eindhoven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-22
Primary Completion
2018-05-01
Completion
2018-06-27

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03180203 on ClinicalTrials.gov