Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
177
Countries
1
Sites
2
Lung Resection Surgery
The main objective of the study is to compare the impact of three different techniques of oxygen administration applied to the non-ventilated lung during one-lung ventilation on the occurrence of postoperative complications.
Key facts
- Sponsor
- Hospital General Universitario Gregorio Maranon
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 27 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-23
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Instituto de Salud Carlos III
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Therapy, Safety
The main objective of the study is to compare the impact of three different techniques of oxygen administration applied to the non-ventilated lung during one-lung ventilation on the occurrence of postoperative complications.
Secondary objectives 1
- The secondary objectives will include a comparison among the three groups of the following aspects: systemic and pulmonary perioperative inflammatory response, incidence of intraoperative hypoxemia, surgical exposure of the operated lung, and average hospital stay.
Conditions and MedDRA coding
Lung Resection Surgery
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10071262 | Partial lung resection | 10042613 |
| 21.1 | LLT | 10002323 | Anesthesia general | 10042613 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Impact of continuous oxygen flow with or without airway pressure in the nondependent lung during one Randomized, single-center, double-blind, phase IV clinical trial with 3 parallel groups
|
Randomised Controlled | Double | [{"id":130230,"code":2,"name":"Investigator"},{"id":130232,"code":5,"name":"Carer"},{"id":130231,"code":1,"name":"Subject"}] | CONTROL Group: The non-dependent lung (surgical) will be connected to ambient air by opening the lumen of the double-lumen tube (DLT) directed towards that lung. CPAP Group: Continuous positive pressure will be added at 2 cm H2O in the non-dependent lung APNEIC OXYGENATION group: A probe will be introduced through the lumen of the DLT to administer a continuous source of oxygen without any associated mechanism that generates pressure in the airway |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 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 1
- Patient with evidence of pulmonary bullae. Pregnancy or breastfeeding. Pneumonectomy. Blood product transfusion within 10 days prior to surgery. Treatment with immunosuppressants or corticosteroids within 3 months prior to surgery. History of contralateral thoracic surgery. Robotic surgery. Patient refusal. Patients included in another clinical trial
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To compare the appearance of postoperatory complication according to the Clavien-Dindo scale.
Secondary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Oxígeno Medicinal Gas Nippon Gases 200 bar, gas comprimido medicinal en bala de gas.
PRD736231 · Product
- Active substance
- Oxygen
- Pharmaceutical form
- MEDICINAL GAS, COMPRESSED
- Route of administration
- INHALATION GAS
- Max daily dose
- 100 % (V/V) percent volume/volume
- Max total dose
- 100 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AN01 — -
- Marketing authorisation
- 67162
- MA holder
- NIPPON GASES ESPANA S.L.U
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital General Universitario Gregorio Maranon
- Sponsor organisation
- Hospital General Universitario Gregorio Maranon
- Address
- Calle Del Doctor Esquerdo 46
- City
- Madrid
- Postcode
- 28009
- Country
- Spain
Scientific contact point
- Organisation
- Hospital General Universitario Gregorio Maranon
- Contact name
- Dr. Francisco de la Gala. Servicio de Anestesiología y Reanimación del HGUGM
Public contact point
- Organisation
- Hospital General Universitario Gregorio Maranon
- Contact name
- Dr. David Martínez. Servicio de Anestesiología y Reanimación del HGUGM
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 177 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2025-01-27 | 2025-01-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-517599-39-00 | 2.1 |
| Protocol (for publication) | D1_Protocol_2024-517599-39-00_2024 12 20_CLEAN | 2.2 |
| Protocol (for publication) | D1_Protocol_2024-517599-39-00_2024 12 20_TC | 2.2 |
| Protocol (for publication) | D1_Protocol_2024-517599-39-00_2025 04 11_CLEAN | 2.3 |
| Protocol (for publication) | D1_Protocol_2024-517599-39-00_2025 04 11_TC | 2.3 |
| Protocol (for publication) | D1_Protocol_2024-517599-39-00_2025 06 10_CLEAN | 2.4 |
| Protocol (for publication) | D1_Protocol_2024-517599-39-00_2025 06 10_TC | 2.4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_updated_2024 12 20_CLEAN | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_updated_2024 12 20_TC | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_updated_CLEAN | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_updated_TC | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Oxigeno medicinal | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Oxigeno medicinal_updated | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ESP_2024-515507-18-00_es | 1.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-10 | Spain | Acceptable 2025-01-23
|
2025-01-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-17 | Spain | Acceptable 2025-07-04
|
2025-07-04 |