Automated Control of Mechanical Ventilation During General Anaesthesia (AVAS)

University Hospital Schleswig-Holstein (UKSH)

Status: Completed

Conditions: Anesthesia

Treatments: Device: Smart Vent Control

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02644005

AVAS

Details and patient eligibility

About

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

Full description

The "Automated control of mechanical ventilation during general anesthesia study (AVAS study) is an international investigator-initiated bicentric observational study investigating the application of Smart Vent Control (SVC) during general anesthesia. The main objective of this study is to describe the application of SVC and to assess its safety and efficacy.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.