Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Patient-ventilator Synchronisation Study for Intensive Care Unit Patients (SyncAutoVNI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03787173
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : April 25, 2019
Sponsor:
Collaborator:
Hamilton Medical AG
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Brief Summary:

This cross-over study will compare the asynchrony index between standard manual ventilator settings, optimized manual ventilator settings, and automated ventilator setting in intensive care patients ventilated in non-invasive ventilation with a high asynchrony index. The hypothesis is that both manual optimized ventilator settings and automated ventilator settings are associated with a lower patient-ventilator asynchrony index as compared to manual standard ventilator settings.

A randomized cross-over design method will be used. Patient requiring NIV with an asynchrony index over 35% will be included. An esophageal catheter with a balloon will be inserted to monitor esophageal pressure. Patients will be ventilated during 3 periods of 30 min, with 10 minutes of washout in between. Recordings of airway pressure, airway flow, and esophageal pressure will be analyzed by two investigators blinded of the trigger settings.

The primary outcome will be the asynchrony index. The secondary outcome will be the ineffective inspiratory effort index, autotrigering index, double triggering index, inspiratory trigger delay, cycling delay, total time spent in asynchrony, patient comfort, and blood gas results.


Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Device: Optimized Device: Automated Not Applicable

Detailed Description:

Non-invasive ventilation (NIV) is used in 35% of patient admitted in intensive care unit (ICU) with a failure rate of 10 to 70% depending on the indication and clinician experience. Patient-ventilator asynchrony is a frequent cause of NIV failure. Therefore, optimizing patient-ventilator synchronization is important for its comfort, tolerance, and efficacy. An optimal patient-ventilation is achieved when the mechanical breath provided by the ventilator match the patient inspiratory effort. The ratio between the number of asynchronies divided by the number of patient inspiratory effort define the asynchrony index (AI). AI over 10% is considered as severe and occurs in 30 to 43% of patients ventilated in NIV. Patient ventilator asynchronies occurs because ventilator settings of inspiratory and expiratory triggers remain constant in patient with variable respiratory drive, and unintentionnals leaks that are difficult to control in NIV. Thus using an automatic adjustment of inspiratory and expiratory triggers setting according to patient effort and unintentional leaks may decrease the number of patient-ventilator asynchronies. This cross-over study will compare the asynchrony index between standard manual ventilator settings, optimized manual ventilator settings, and automated ventilator setting in intensive care patients ventilated in non-invasive ventilation with a high asynchrony index. The hypothesis is that both manual optimized ventilator settings and automated ventilator settings are associated with a lower patient-ventilator asynchrony index as compared to manual standard ventilator settings.

A randomized cross-over design method will be used. Patient requiring NIV with an asynchrony index over 30% will be included. An esophageal catheter with a balloon will be inserted to monitor esophageal pressure. Patients will be ventilated during 3 periods of 30 min, with 10 minutes of washout in between. Recordings of airway pressure, airway flow, and esophageal pressure will be analyzed by two investigators blinded of the trigger settings.

The primary outcome will be the asynchrony index. The secondary outcome will be the ineffective inspiratory effort index, autotrigering index, double triggering index, inspiratory trigger delay, cycling delay, total time spent in asynchrony, patient comfort, and blood gas results.

The sample size was calculated from the total asynchrony index (primary outcome). Patients with an asynchrony index over 30% in using manual standard ventilator settings will be included. Considering an asynchrony index of 30 ± 15 % in manual standard ventilator settings with a clinically significant objective to reduce the asynchrony index to 15% in manual optimized ventilator settings and automated ventilator settings, a sample size of 30 patients is required with a risk at 0.05 and a power at 80%. Therefore, 35 patients are planned.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Patient-ventilator Synchronisation Study in Non Invasive Ventilation for Intensive Care Unit Patients: Comparison Between Manual and Automated Ventilator Settings.
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020


Arm Intervention/treatment
No Intervention: Manual standard ventilator settings
Inspiratory trigger set at 2 l/min, Expiratory trigger set at 25% of peak inspiratory flow
Active Comparator: Manual optimized ventilator settings
Inspiratory trigger and Expiratory trigger settings optimized by investigator
Device: Optimized
Inspiratory trigger and Expiratory trigger settings optimized by investigator

Experimental: Automated ventilator settings
Inspiratory trigger and Expiratory trigger settings automatized
Device: Automated
Inspiratory trigger and Expiratory trigger settings automatized




Primary Outcome Measures :
  1. Asynchrony index [ Time Frame: Continuous measurement over 30min ]
    Ratio between the total number of asynchronies divided by the number of patient inspiratory effort


Secondary Outcome Measures :
  1. Lineffective inspiratory effort index [ Time Frame: Continuous measurement over 30min ]
    Ratio between the total number of ineffective inspiratory effort divided by the number of patient inspiratory effort

  2. Autotrigering index [ Time Frame: Continuous measurement over 30min ]
    Ratio between the total number of autotriggered breath divided by the number of patient inspiratory effort

  3. Double triggering index [ Time Frame: Continuous measurement over 30min ]
    Ratio between the total number of double triggered breath divided by the number of patient inspiratory effort

  4. Inspiratory trigger delay [ Time Frame: Continuous measurement over 30min ]
    Time between the beginning of patient effort assessed on oesophageal pressure and beginning of mechanical breath.

  5. Cycling delay [ Time Frame: Continuous measurement over 30min ]
    Time between the end of patient effort assessed on oesophageal pressure and the end of mechanical breath.

  6. Total time spent in asynchrony [ Time Frame: Continuous measurement over 30min ]
    Ratio of total time of ineffective inspiratory effort, inspiratory trigger delay, and cycling delay on total time of recording.

  7. Patient comfort [ Time Frame: 1 day (Single measurement) ]
    Visual analog scale of Likert type measuring patient comfort going from 0 (very uncomfortable) to 10 (very comfortable)

  8. Blood PaO2 results [ Time Frame: After each period at 30 min, 1 h and 1 h 30 min ]
    PaO2

  9. Blood PaCO2 results [ Time Frame: After each period at 30 min, 1 h and 1 h 30 min ]
    PaCO2

  10. Blood pH results [ Time Frame: After each period at 30 min, 1 h and 1 h 30 min ]
    pH



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Patient aged over 18 years old
  • Covered by social insurance
  • Consent for study signed by patient or next-of-kin
  • NIV session indicated for at least 2 hours
  • Asynchrony index ≥ 30% with standard manual settings

Exclusion Criteria:

  • Patient requiring continuous NIV
  • Contra-indication to esophageal catheter insertion: gastric ulcer, esophageal varices, pharyngeal or laryngeal tumor.
  • Patient with withholding decision about intubation
  • Moribund patient
  • Patient included in another interventional study in the last 30 days
  • Patient that does not speak French
  • Pregnant women

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): NCT03787173


Contacts
Layout table for location contacts
Contact: Anaïs Maugard 04.94.14.55.29 ext +33 anais.maugardlandre@ch-toulon.fr

Locations
Layout table for location information
France
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer Recruiting
Toulon, Var, France, 83056
Contact: Aude Garnero, MD    04 94 14 58 62 ext +33    aude.garnero@gmail.com   
Sub-Investigator: Jean-Michel Arnal, MD         
Sponsors and Collaborators
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Hamilton Medical AG
Investigators
Layout table for investigator information
Principal Investigator: Aude Garnero, MD Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Publications:

Layout table for additonal information
Responsible Party: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
ClinicalTrials.gov Identifier: NCT03787173     History of Changes
Other Study ID Numbers: 2018-CHITS-01
2018-A00658-47 ( Other Identifier: Id-RCB )
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer:
non invasive ventilation
patient ventilator synchrony
acute respiratory failure
closed loop ventilation

Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases