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Impact of Applying a Reduced Oxygen Concentration Before Extubation on the Functional Residual Capacity in Patients with Obesity - a randomized controlled clinical trial

Impact of Applying a Reduced Oxygen Concentration Before Extubation on the Functional Residual Capacity in Patients with Obesity - a randomized controlled clinical trial - OXY-REDUCE

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00036465
Enrollment
46
Registered
2025-03-24
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Obese patients undergoing surgery with general anesthesia

Interventions

Group 1: Obese patients with a BMI > 30 kg/m2 undergoing elective laparoscopic surgery with general anesthesia and endotracheal intubation who will be extubated with an FiO2 ( inspiratory oxygen conce

Sponsors

Universitätsklinikum Augsburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients undergoing an elective laparoscopic surgical procedure under general anesthesia with endotracheal intubation - BMI = 30 kg/m² and = 40 kg/m² - Expected intubation duration = 1 hour - Informed consent obtained

Exclusion criteria

Exclusion criteria: - Previous lung surgery - Known or expected difficult intubation (despite the use of a video laryngoscope) - Persistent hemodynamic instability - Severe COPD or bronchial asthma (non-invasive ventilation and/or long-term oxygen therapy, repeated systemic corticosteroid administration due to frequent exacerbations) - Immunosuppressive medication or radiation therapy within the last months before inclusion - Heart failure = NYHA III, acute cardiac syndromes - Pregnancy (exclusion by history or lab test) - Severe pulmonary arterial hypertension, defined as a systolic pulmonary arterial pressure > 40 mmHg - Increased intracranial pressure - Any neuromuscular disease - Implanted heart support systems, pacemakers, or ICDs - Intraoperative abdominal or lateral positioning - Procedures with one-lung ventilation - Cardiac/thoracic surgical procedures - Neurosurgical procedures - Enrollment in another interventional study according to the German Medicines Act (AMG)/Medical Devices Act (MDPG) or failure to consent to participation in the study

Design outcomes

Primary

MeasureTime frame
Difference in Functional Residual Capacity (FRC) 30 min after extubation compared to baseline before induction of general anesthesia = ?FRC 30 min after extubation (FIO2 0.5) vs. ?FRC 30 min After Extubation (FIO2 1.0)

Secondary

MeasureTime frame
- Ventro-dorsal ventilation distribution measured by electrical impedance tomography (EIT) - Arterial partial pressure of oxygen (paO2)

Countries

Germany

Contacts

Public ContactPhilipp Simon

Universitätsklinikum Augsburg

philipp.simon3@uk-augsburg.de+49 821 400 2378

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026