Protective Flow Controlled Ventilation during One Lung Anesthesia (PROFLONE) – A Randomized Controlled Trial
- Conditions
- intraoperative one-lung ventilation
- Registration Number
- DRKS00022198
- Lead Sponsor
- Technische Universität Dresden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 78
Patients with planned thoracic surgery (open or video-assisted) under one-lung ventilation using a double lumen tube and invasive monitoring of arterial blood pressure
- ASA = 3
- Planned duration of intervention > 30 min
- Age = 18
- Weight > 40 kg
- Written consent of the participating person
- COPD GOLD grade 3 and 4
- Untreated asthma
- Lung separation using a method other than DLT (e.g. difficult airway, tracheostomy)
- Contraindications against total intravenous anaesthesia
- History of hypersensitivity/allergy to one of the medications to be used or their ingredients or to medication with a similar chemical structure
- Participation of the patient in another clinical trial within the last 4 weeks before inclusion
- Addictions or other illnesses which do not allow the person concerned to assess the nature and extent of the clinical trial and its possible consequences
- Pregnant or breastfeeding women
- Women of childbearing age, except women who meet the following criteria:
> Post-menopausal (12 months natural amenorrhoea or 6 months amenorrhoea with serum FSH > 40 mlU/ml)
> Postoperative (6 weeks after bilateral ovarectomy with or without hysterectomy)
> Regular and correct use of a contraceptive method with a failure rate < 1% per year (e.g. implants, depot injections, oral contraceptives, intrauterine device - IUD).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary end point is the arterial oxygen partial pressure (PaO2) 20 min after initiation of one-lung ventilation.
- Secondary Outcome Measures
Name Time Method (1) Intraoperative complications <br>(2) Necessity of intraoperative rescue maneuvers in case of gas exchange disturbances <br>(3) Need for intraoperative rescue maneuvers in cases of hemodynamic instability <br>(4) postoperative pulmonary and extrapulmonary complications <br>(5) advanced postoperative pulmonary complications<br>(6) arterial blood gas analyses during dual and single lung ventilation (pCO2, pO2, pH) <br>(7) PaO2/FIO2 after OP end <br>(8) Intraoperative respiratory mechanics <br>(9) Mechanical Power <br>(10) Length of hospital stay <br>(11) Number of days spent at home on the postoperative day 30 after surgery