Automated Control of Mechanical Ventilation During General Anaesthesia

NCT02644005 | Completed

• 1 other identifier: AVAS
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief Summary

Prospective, bicentric observational study to assess a novel system for automated control of mechanical ventilation (Smart Vent Control, SVC) during general anesthesia.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Frequency of adverse events.

  * Severe hypoventilation defined as minute volume lower than 40 ml/kg predicted body weight for longer than 5 minutes * Apnea for longer than 90 seconds * Hyperventilation defined as PetCO2 lower than 5 mm Hg of the lower target setting for SVC for longer than 5 minutes * Hypoventilation defined as PetCO2 higher than 5 mm Hg of the upper target setting for the SVC for longer than 5 minutes * Respiratory rate \> 35 breaths per minute for longer than 5 minutes * Any override or stop of the automated controlled ventilation settings by the anesthesiologist in charge if the settings are clinically not acceptable. Reasons for overriding or stopping the system will be noted.

  During artificial ventilation with SVC (up to 8 hours).

Secondary Outcomes (10)

• Frequency of normoventilated, hypoventilated and hyperventilated patients.

  During artificial ventilation with SVC (up to 8 hours).

• Time period between switch from controlled ventilation to augmented ventilation and achievement of stable assisted ventilation of the patient.

  During artificial ventilation with SVC (up to 8 hours).

• Proportion of time within the target zones for tidal volume and PetCO2 as individually set up for each patient by the user.

  During artificial ventilation with SVC (up to 8 hours).

• Frequency of alarms.

  During artificial ventilation with SVC (up to 8 hours).

• Frequency distribution of tidal volume (ml/kg predicted body weight).

  During artificial ventilation with SVC (up to 8 hours).

Interventions

Smart Vent Control DEVICE

Smart Vent Control (SVC) was designed to automatically control the following ventilator settings: mechanical breathing frequency, inspiratory pressure, pressure support, inspiratory time, trigger sensitivity. SVC adjusts the ventilator settings with the aim to keep a patient stable in a target zone (TZ). Numerous predefined TZs exist that can be set according to the current therapeutic situation. All TZs are adoptable by the user for each individual patient and consist of upper and lower limits for tidal volume and for the partial pressure of end-tidal carbon dioxide (PetCO2). Based on these limits, the system classifies the current quality of ventilation, called Classification of Ventilation, and derives new ventilator settings accordingly. SVC is available as a software option on Zeus Infinity Empowered anesthesia machines (Drägerwerk AG \& Co. KGAa, Lübeck, Germany) and is approved as a medical product according to 93/42/European Economic Community.

Eligibility Criteria

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

Study Population

Adult patients scheduled for elective surgery in general anesthesia.

You may qualify if:

• Planned elective surgery of the upper limb, lower limb or peripheral vascular surgery in general anesthesia
• Patient is classified as American Society of Anesthesiologists physical status (ASA) I, II or III
• Age ≥ 18 years
• Written consent of the patient for study participation

You may not qualify if:

• Mild, moderate or severe acute respiratory distress syndrome (ARDS)\[10\]
• Known chronic obstructive pulmonary disease Gold stage III or higher
• Two or more of the following organ failures
• Mild, moderate or severe ARDS
• Hemodynamic instability: systolic blood pressure \< 90 mm Hg, mean arterial pressure \< 70 mm Hg or administration of any vasoactive drugs.
• Acute renal failure: oliguria (urine output \< 0.5 ml/kg/h for at least 2 hours despite of adequate management or creatinine increase \> 0.5 mg/dl
• Cerebral failure: loose of consciousness or encephalopathy
• Patient is pregnant.

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead
• Drägerwerk AG & Co. KGaA: collaborator

Study Sites (2)

University Hospital St. Pölten, Department of Anesthesiology and Intensive Care Medicine

Sankt Pölten, A-3100, Austria

Location

University Medical Center Schleswig-Holstein, Campus Kiel, Department of Anesthesiology and Intensive Care Medicine

Kiel, 24105, Germany

Location

Related Publications (1)

• Schadler D, Miestinger G, Becher T, Frerichs I, Weiler N, Hormann C. Automated control of mechanical ventilation during general anaesthesia: study protocol of a bicentric observational study (AVAS). BMJ Open. 2017 May 10;7(5):e014742. doi: 10.1136/bmjopen-2016-014742.

  PMID: 28495814 BACKGROUND

Study Officials

• Norbert Weiler, M.D.

  University Medical Center Schleswig-Holstein, Campus Kiel, Germany, Department of Anesthesiology and Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

• Christoph Hörmann, M.D.

  University Hospital St. Pölten, Austria, Department of Anesthesiology and Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Norbert Weiler

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 31, 2015
• Study Start: July 7, 2017
• Primary Completion: March 7, 2019
• Study Completion: March 7, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); DE (1)