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Protective Variable Controlled Ventilation during One Lung Anesthesia (PROVALUNG) – A Randomized Controlled Trial

Protective Variable Controlled Ventilation during One Lung Anesthesia (PROVALUNG) – A Randomized Controlled Trial - PROVALUNG

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00022202
Enrollment
78
Registered
2020-06-16
Start date
2020-05-26
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative one-lung ventilation

Interventions

Group 1: Conventional volume-controlled one-lung ventilation Group 2: Variable volume-controlled one-lung ventilation

Sponsors

Technische Universität Dresden
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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).

Design outcomes

Primary

MeasureTime frame
The primary end point is the arterial oxygen partial pressure (PaO2) 20 min after initiation of one-lung ventilation.

Secondary

MeasureTime frame
(1) Intraoperative complications (2) Necessity of intraoperative rescue maneuvers in case of gas exchange disturbances (3) Need for intraoperative rescue maneuvers in cases of hemodynamic instability (4) postoperative pulmonary and extrapulmonary complications (5) advanced postoperative pulmonary complications (6) arterial blood gas analyses during dual and single lung ventilation (pCO2, pO2, pH) (7) PaO2/FIO2 after OP end (8) Intraoperative respiratory mechanics (9) Mechanical Power (10) Length of hospital stay (11) Number of days spent at home on the postoperative day 30 after surgery

Countries

Germany

Contacts

Public ContactMarcelo Gama de Abreu

Universitätsklinikum Carl Gustav Carus

mgabreu@ukdd.de0351 458 19777

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 8, 2026