Clinical trial • Phase IV • Oncology|Respiratory

OXYGEN for Lung resection surgery|Partial lung resection

Phase IV trial of OXYGEN for Lung resection surgery|Partial lung resection.

Overview

Trial Therapeutic Area
Oncology|Respiratory
Trial Disease
Lung resection surgery|Partial lung resection
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
10-10-2024
First CTIS Authorization Date
23-01-2025

Trial design

Randomised, three parallel arms: control group - non-dependent lung connected to ambient air by opening the lumen of the double-lumen tube (dlt); cpap group - continuous positive pressure added at 2 cm h2o to the non-dependent lung; apneic oxygenation group - probe introduced through the dlt lumen to administer a continuous source of oxygen without any mechanism that generates airway pressure. Phase IV trial across 2 sites in Spain.

Randomised
Yes
Comparator
Three parallel arms: CONTROL Group - non-dependent lung connected to ambient air by opening the lumen of the double-lumen tube (DLT); CPAP Group - continuous positive pressure added at 2 cm H2O to the non-dependent lung; APNEIC OXYGENATION group - probe introduced through the DLT lumen to administer a continuous source of oxygen without any mechanism that generates airway pressure.
Target Sample Size
177

Eligibility

Recruits 177 No vulnerable populations selected. Subjects must be over 18 years of age and legally competent; voluntary acceptance and signing of informed consent is required..

Pregnancy Exclusion
Pregnancy or breastfeeding.
Vulnerable Population
No vulnerable populations selected. Subjects must be over 18 years of age and legally competent; voluntary acceptance and signing of informed consent is required.

Inclusion criteria

  • {"criterion_text":"- Patients over 18 years of age, legally competent, of both sexes, scheduled to undergo Lung Resection Surgery requiring lung isolation with a double-lumen tube. Voluntary acceptance to participate in the study and signing of informed consent."}

Exclusion criteria

  • {"criterion_text":"- Patient with evidence of pulmonary bullae.\n- Pregnancy or breastfeeding.\n- Pneumonectomy.\n- Blood product transfusion within 10 days prior to surgery.\n- Treatment with immunosuppressants or corticosteroids within 3 months prior to surgery.\n- History of contralateral thoracic surgery.\n- Robotic surgery.\n- Patient refusal.\n- Patients included in another clinical trial"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- To compare the appearance of postoperatory complication according to the Clavien-Dindo scale.","definition_or_measurement_approach":"Occurrence and severity of postoperative complications assessed and compared across groups using the Clavien-Dindo classification (revised for thoracic surgery); proportion of patients in each Clavien-Dindo category will be compared between groups."}

Secondary endpoints

  • {"endpoint_text":"- The following aspects will be compared among the three groups: gas exchange and acid-base balance during intra and postoperative periods, degree of interference with surgical exposure, incidence of postoperative pulmonary complications, length of stay in special care units, need for readmission to those units, duration of hospital stay, hospital readmission, comparison of inflammatory biomarkers in blood and bronchoalveolar lavage, identification of new molecules involved in oxidative stress.","definition_or_measurement_approach":"These outcomes will be compared among the three randomized groups using physiologic measurements (gas exchange and acid-base parameters intra- and postoperatively), qualitative/quantitative assessment of surgical exposure, incidence rates for pulmonary complications, lengths of stay and readmission counts, and laboratory assays for inflammatory biomarkers in blood and bronchoalveolar lavage; identification of molecules related to oxidative stress via biomarker analyses."}

Recruitment

Planned Sample Size
177
Recruitment Window Months
26
Consent Approach
Voluntary informed consent signed by the participant; subjects must be over 18 and legally competent. Subject information and informed consent form documents are listed in the trial documents (multiple versions); translations/documents include Spanish.

Geography

Total Number Of Sites
2
Total Number Of Participants
177

Spain

Earliest CTIS Part Ii Submission Date
23-12-2024
Latest Decision Or Authorization Date
23-01-2025
Processing Time Days
31
Number Of Sites
2
Number Of Participants
177

Sites

Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Anestesiología y Reanimación
Principal Investigator Name
Francisco Andrés De La Gala García
Principal Investigator Email
dmgascuena@salud.madrid.org
Contact Person Name
Francisco Andrés De La Gala García
Contact Person Email
dmgascuena@salud.madrid.org
Site Name
Complutense University Of Madrid
Department Name
Bioquímica
Principal Investigator Name
Elena María Vara Ameigeiras
Principal Investigator Email
evaraami@ucm.es
Contact Person Name
Elena María Vara Ameigeiras
Contact Person Email
evaraami@ucm.es

Sponsor

Primary sponsor

Full Name
Hospital General Universitario Gregorio Maranon
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Oxígeno Medicinal Gas Nippon Gases 200 bar, gas comprimido medicinal en bala de gas.
Active Substance
OXYGEN
Modality
Small molecule
Routes Of Administration
Inhalation (gas)
Route
INHALATION GAS
Authorisation Status
Marketing authorisation in Spain (marketingAuthNumber: 67162)
Maximum Dose
100 % (V/V)

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