Lung Resection SurgeryPhase 4NCT07461779
Effect of Oxygen Administration in the Non-dependent Lung on Postoperative Complications After Lung Surgery
A Phase 4 study testing Medicinal gas - oxygen (Nippon Gases 200 bar), CPAP and Oxygen therapy according to standard clinical practice in people with Lung Resection Surgery and Anesthesia General, run by Francisco Andres de la Gala at 1 site in Spain.
Trial summary
The purpose of this study is to analyze the effectiveness of apneic oxygenation and CPAP applied to the non-dependent lung during pulmonary resection surgery in reducing inflammatory response, ischemia-reperfusion injury, and postoperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Resection Surgery, Anesthesia General
- What is being tested?
- Medicinal gas - oxygen (Nippon Gases 200 bar), CPAP and Oxygen therapy according to standard clinical practice
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteSpain
- Study dates
- 27 Jan 2025to 30 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both genders undergoing lung resection surgery in the Thoracic Surgery Department at Hospital General Universitario Gregorio Marañón
- Lung isolation using a double-lumen tube (DLT)
- Scheduled surgery
- Patients able and willing to give written informed consent
- Patients over 18 years old and legally competent
Who cannot join
- Patients with evidence of pulmonary bullae
- Pregnancy or breastfeeding
- Blood transfusion within 10 days prior to surgery
- Treatment with immunosuppressants or corticosteroids within 3 months prior to surgery
- Patient refusal to participate
- Prior contralateral thoracic surgery
Show all 9Show fewer
- Robotic surgery
- Pneumonectomy
- Enrollment in another clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Francisco de la Gala, MD, PhD, +34915868367, francisco.gala@salud.madrid.org
Ignacio Garutti, MD, +34915868367, ignacio.garutti@salud.madrid.org
About this study
Official title: Impact of Continuous Oxygen Flow With or Without Airway Pressure in the Non-dependent Lung During One-lung Ventilation on Postoperative Complications in Lung Resection Surgery: A Randomized Controlled Clinical Trial
The purpose of this study is to analyze the effectiveness of apneic oxygenation and CPAP applied to the non-dependent lung during pulmonary resection surgery in reducing inflammatory response, ischemia-reperfusion injury, and postoperative complications. We will conduct a randomized, controlled, and blinded study in 177 patients with three arms:
- Control Group: Oxygen therapy according to standard clinical practice
- Apneic oxygenation group: A probe will be introduced through the lumen of the double-lumen tube (DLT) to administer a continuous source of oxygen without any mechanism that generates airway pressure.
- CPAP Group: Continuous positive airway pressure with 3-5 L/min oxygen flow and 2 cm H2O pressure delivered via a Mapleson system.
Inflammatory mediators in blood and in both lungs will be measured intraoperatively and 24 hours after surgery. Patients will be followed from hospital admission until discharge and again 30 days after surgery to evaluate the postoperative course, particularly the occurrence of complications according to the revised Clavien-Dindo classification for thoracic surgery, as well as other relevant clinical outcomes.
Read the detailed description
Surgical interventions, particularly lung resection, provoke a significant inflammatory response at both local and systemic levels, characterized by hyperemia and increased vascular permeability. Thoracic surgery requiring one-lung ventilation (OLV) leads to complications such as intraoperative hypoxemia and an exaggerated pulmonary inflammatory response, threatening patient stability. Hypoxemia-commonly defined as SpO2 < 85-90% or PaO2 < 60 mmHg-is frequent and increases the risk of complications such as arrhythmias, cognitive dysfunction, pulmonary hypertension, and renal failure, particularly in patients with comorbidities. The difficulty in defining a precise threshold for complications reflects that oxygen deprivation-related tissue hypoxia depends on the balance between oxygen supply and consumption, which is influenced by individual variables such as cardiovascular function and pre-existing conditions.
To mitigate hypoxemia during OLV, several strategies have been implemented. The most common are increasing FiO2 and applying continuous positive airway pressure (CPAP), which significantly improves arterial oxygenation. However, higher pressures may hinder surgical manipulation due to anatomical distortion. Currently, low-pressure CPAP (around 2 cmH2O) is recommended because it provides oxygenation benefits without interfering with the surgery, although clinical evidence remains limited. Apneic oxygenation has also been proposed: oxygen is administered without positive pressure, taking advantage of the fact that during apnea oxygen can diffuse into the alveoli down pressure gradients, sustaining arterial oxygenation even with collapsed lung regions. This technique can prolong safe apnea time, reduce hyperoxia risk, and maintain oxygenation while minimizing interference with surgical exposure.
Conversely, OLV triggers a strong inflammatory response caused by tissue injury, atelectrauma, volutrauma, and barotrauma in the dependent lung, along with oxidative stress damage in the non-ventilated lung. Prolonged exposure to high FiO2 contributes to lung injury through oxidative mechanisms similar to those in adult acute respiratory distress syndrome. Re-expansion of the collapsed lung after OLV also releases free radicals, exacerbating ischemia-reperfusion injury, especially in lung cancer patients who may have reduced antioxidant capacity. Activation of the NLRP3 inflammasome, stimulated by reactive oxygen species, promotes proinflammatory cytokine production, contributing to tissue damage, increased capillary permeability, and pulmonary edema, thereby raising the risk of postoperative respiratory failure.
Although advances have been made, evidence is limited regarding the impact of apneic oxygenation on reducing inflammation, oxidative stress, and postoperative complications in lung surgery. However, studies in other surgeries suggest this technique could decrease inflammatory markers and improve oxygenation without impairing surgical exposure. Therefore, this study aims to evaluate and compare the efficacy of apneic oxygenation and CPAP applied to the nondependent lung during lung resection surgery, focusing on reducing inflammatory response, ischemia-reperfusion injury, and postoperative complications, and thus providing evidence to improve perioperative strategies for these patients.
Hypothesis: Maintaining a continuous oxygen flow to the nondependent lung, with minimal pressure (CPAP) or none at all (apneic oxygenation), during OLV will reduce alveolar hypoxia in that lung, thereby attenuating ischemia-reperfusion-related lung injury and improving the postoperative course. Additionally, it will reduce the incidence of intraoperative hypoxemia and permit use of lower oxygen concentrations to the dependent lung, which may further improve prognosis.
- Conditions
- Lung Resection Surgery, Anesthesia General
- Being tested
- Medicinal gas - oxygen (Nippon Gases 200 bar), CPAP, Oxygen therapy according to standard clinical practice
- Keywords
- Postoperative complications, Thoracic surgery
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicinal gas - oxygen (Nippon Gases 200 bar)Drug
Medicinal gas, compressed. Oxygen 99.5% v/v
CPAPDevice
Continuous positive pressure
Oxygen therapy according to standard clinical practiceProcedure or surgery
Ambient air connection
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Oxygen therapy according to standard clinical practice. The nondependent lung (surgical) will be connected to ambient air by opening the lumen of the double-lumen tube (DLT) directed towards that lung Receives: Procedure: Oxygen therapy according to standard clinical practice |
| CPAP Group | Experimental | Continuous positive airway pressure with 3-5 L/min oxygen and 2 cmH2O pressure delivered via a Mapleson system Receives: Device: CPAP |
| APNEIC OXYGENATION group | Experimental | A probe will be introduced through the lumen of the DLT to deliver a continuous flow of oxygen without any mechanism that generates airway pressure Receives: Drug: Medicinal gas - oxygen (Nippon Gases 200 bar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
To compare the proportion of patients in each grade of the revised Clavien-Dindo classification for thoracic surgery across the three study groups
Measured: Up to 30 days after intervention
Secondary outcomes (9)
Gas exchange and acid-base balance
To compare gas exchange and acid-base balance during the intraoperative period and during the first 24 hours postoperatively
Measured: Intraoperative period and 24 hours
Degree of interference with surgical exposure (Surgeon Satisfaction Scale on Oxygen Therapy Interference, 1-5)
Assessed by the surgeon at the end of the procedure using the Surgeon Satisfaction Scale on Oxygen Therapy Interference, an ordinal 5-point scale: 1 = Surgery impossible (change O2 administration method required); 2 = Very difficult technique (no change in O2 administration required); 3 = Considerably more difficult than usual; 4 = Somewhat more difficult than usual; 5 = Similar to usual.
Measured: Surgery duration; assessed at end of surgery
Incidence of postoperative pulmonary complications
To compare de incidence of postoperative pulmonary complications among the three study groups
Measured: Up to 30 days after intervention
Special Care Units stay
To compare the length of stay in Special Care Units among the three study groups
Measured: Up to 30 days after intervention
Readmisions to Special Care Units
To compare the number of readmissions to Special Care Units among the three study groups
Measured: Up to 30 days after intervention
Hospital Stay
To compare the average hospital stay (measure in days) among the three study groups
Measured: Up to 30 days after intervention
Hospital readmission
To compare hospital readmissions among the three study groups
Measured: Up to 30 days after intervention
Inflammatory biomarkers in blood and bronchoalveolar lavages
To evaluate the inflammatory response measured in blood and bronchoalveolar lavages during the first 24 hours postoperatively in the three patient groups. Blood samples and bronchoalveolar lavages will be taken at the beginning of surgery, at the end of one-lung ventilation, and at 24 hours postoperatively
Measured: Up to 24 hours after intervention
New molecules involved in oxidative stress
Identification of new molecules involved in oxidative stress: Plasma concentrations of oxidative stress markers (SOD, MDA, MPO, CP, ROS index, plasma thiols). All biochemical determinations will be performed by spectrophotometry using validated specific kits. Samples collected pre-intervention and at 2, 6 and 24 hours post-intervention.
Measured: Up to 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start27 Jan 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Resection SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into three groups based on the anesthetic technique used: Control Group (oxygen therapy according to standard clinical practice), Intervention Group 1 (apneic oxygenation), and Intervention Group 2 (CPAP). Randomization will be performed using EPIDAT 3.1 program. Randomization codes will be obtained prior to the recruitment of the first patient and will be placed in sealed, sequentially numbered envelopes. The operating-room anesthesiologist will open the envelope for each patient and will prepare the assigned intervention and collect the study data.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francisco Andres de la Gala
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor-investigator, Francisco Andres de la Gala, Hospital General Universitario Gregorio Marañon
- Investigators
- Francisco de la Gala, MD, PhD, Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461779
- Sponsor's protocol ID
- ECAOI-22
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Continuous Oxygen Flow With or Without Airway Pressure in the Non-dependent Lung During One-lung Ventilation on Postoperative Complications in Lung Resection Surgery: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07461779
- Acronym / sponsor ID
- ECAOI-22
- Conditions
- Lung Resection Surgery, Anesthesia General
- Keywords
- Postoperative complications, Thoracic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Francisco Andres de la GalaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to analyze the effectiveness of apneic oxygenation and CPAP applied to the non-dependent lung during pulmonary resection surgery in reducing inflammatory response, ischemia-reperfusion injury, and postoperative complications. We will conduct a randomized, controlled, and blinded study in 177 patients with three arms:
- Control Group: Oxygen therapy according to standard clinical practice
- Apneic oxygenation group: A probe will be introduced through the lumen of the double-lumen tube (DLT) to administer a continuous source of oxygen without any mechanism that generates airway pressure.
- CPAP Group: Continuous positive airway pressure with 3-5 L/min oxygen flow and 2 cm H2O pressure delivered via a Mapleson system.
Inflammatory mediators in blood and in both lungs will be measured intraoperatively and 24 hours after surgery. Patients will be followed from hospital admission until discharge and again 30 days after surgery to evaluate the postoperative course, particularly the occurrence of complications according to the revised Clavien-Dindo classification for thoracic surgery, as well as other relevant clinical outcomes.
Detailed description
Surgical interventions, particularly lung resection, provoke a significant inflammatory response at both local and systemic levels, characterized by hyperemia and increased vascular permeability. Thoracic surgery requiring one-lung ventilation (OLV) leads to complications such as intraoperative hypoxemia and an exaggerated pulmonary inflammatory response, threatening patient stability. Hypoxemia-commonly defined as SpO2 < 85-90% or PaO2 < 60 mmHg-is frequent and increases the risk of complications such as arrhythmias, cognitive dysfunction, pulmonary hypertension, and renal failure, particularly in patients with comorbidities. The difficulty in defining a precise threshold for complications reflects that oxygen deprivation-related tissue hypoxia depends on the balance between oxygen supply and consumption, which is influenced by individual variables such as cardiovascular function and pre-existing conditions.
To mitigate hypoxemia during OLV, several strategies have been implemented. The most common are increasing FiO2 and applying continuous positive airway pressure (CPAP), which significantly improves arterial oxygenation. However, higher pressures may hinder surgical manipulation due to anatomical distortion. Currently, low-pressure CPAP (around 2 cmH2O) is recommended because it provides oxygenation benefits without interfering with the surgery, although clinical evidence remains limited. Apneic oxygenation has also been proposed: oxygen is administered without positive pressure, taking advantage of the fact that during apnea oxygen can diffuse into the alveoli down pressure gradients, sustaining arterial oxygenation even with collapsed lung regions. This technique can prolong safe apnea time, reduce hyperoxia risk, and maintain oxygenation while minimizing interference with surgical exposure.
Conversely, OLV triggers a strong inflammatory response caused by tissue injury, atelectrauma, volutrauma, and barotrauma in the dependent lung, along with oxidative stress damage in the non-ventilated lung. Prolonged exposure to high FiO2 contributes to lung injury through oxidative mechanisms similar to those in adult acute respiratory distress syndrome. Re-expansion of the collapsed lung after OLV also releases free radicals, exacerbating ischemia-reperfusion injury, especially in lung cancer patients who may have reduced antioxidant capacity. Activation of the NLRP3 inflammasome, stimulated by reactive oxygen species, promotes proinflammatory cytokine production, contributing to tissue damage, increased capillary permeability, and pulmonary edema, thereby raising the risk of postoperative respiratory failure.
Although advances have been made, evidence is limited regarding the impact of apneic oxygenation on reducing inflammation, oxidative stress, and postoperative complications in lung surgery. However, studies in other surgeries suggest this technique could decrease inflammatory markers and improve oxygenation without impairing surgical exposure. Therefore, this study aims to evaluate and compare the efficacy of apneic oxygenation and CPAP applied to the nondependent lung during lung resection surgery, focusing on reducing inflammatory response, ischemia-reperfusion injury, and postoperative complications, and thus providing evidence to improve perioperative strategies for these patients.
Hypothesis: Maintaining a continuous oxygen flow to the nondependent lung, with minimal pressure (CPAP) or none at all (apneic oxygenation), during OLV will reduce alveolar hypoxia in that lung, thereby attenuating ischemia-reperfusion-related lung injury and improving the postoperative course. Additionally, it will reduce the incidence of intraoperative hypoxemia and permit use of lower oxygen concentrations to the dependent lung, which may further improve prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be randomized into three groups based on the anesthetic technique used: Control Group (oxygen therapy according to standard clinical practice), Intervention Group 1 (apneic oxygenation), and Intervention Group 2 (CPAP). Randomization will be performed using EPIDAT 3.1 program. Randomization codes will be obtained prior to the recruitment of the first patient and will be placed in sealed, sequentially numbered envelopes. The operating-room anesthesiologist will open the envelope for each patient and will prepare the assigned intervention and collect the study data.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Oxygen therapy according to standard clinical practiceOxygen therapy according to standard clinical practice. The nondependent lung (surgical) will be connected to ambient air by opening the lumen of the double-lumen tube (DLT) directed towards that lung |
| CPAP Group | Experimental | Device: CPAPContinuous positive airway pressure with 3-5 L/min oxygen and 2 cmH2O pressure delivered via a Mapleson system |
| APNEIC OXYGENATION group | Experimental | Drug: Medicinal gas - oxygen (Nippon Gases 200 bar)A probe will be introduced through the lumen of the DLT to deliver a continuous flow of oxygen without any mechanism that generates airway pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of both genders undergoing lung resection surgery in the Thoracic Surgery Department at Hospital General Universitario Gregorio Marañón
- Lung isolation using a double-lumen tube (DLT)
- Scheduled surgery
- Patients able and willing to give written informed consent
- Patients over 18 years old and legally competent
Key exclusion criteria (9 listed)
- Patients with evidence of pulmonary bullae
- Pregnancy or breastfeeding
- Blood transfusion within 10 days prior to surgery
- Treatment with immunosuppressants or corticosteroids within 3 months prior to surgery
- Patient refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medicinal gas - oxygen (Nippon Gases 200 bar)Medicinal gas, compressed. Oxygen 99.5% v/v | Drug | APNEIC OXYGENATION group |
| CPAPContinuous positive pressure | Device | CPAP Group |
| Oxygen therapy according to standard clinical practiceAmbient air connection | Procedure or surgery | Control group |
Primary outcome
Postoperative complications
Time frame: Up to 30 days after intervention
To compare the proportion of patients in each grade of the revised Clavien-Dindo classification for thoracic surgery across the three study groups
9 secondary outcomes
Gas exchange and acid-base balance
Time frame: Intraoperative period and 24 hours
Degree of interference with surgical exposure (Surgeon Satisfaction Scale on Oxygen Therapy Interference, 1-5)
Time frame: Surgery duration; assessed at end of surgery
Incidence of postoperative pulmonary complications
Time frame: Up to 30 days after intervention
Special Care Units stay
Time frame: Up to 30 days after intervention
Readmisions to Special Care Units
Time frame: Up to 30 days after intervention
Hospital Stay
Time frame: Up to 30 days after intervention
Hospital readmission
Time frame: Up to 30 days after intervention
Inflammatory biomarkers in blood and bronchoalveolar lavages
Time frame: Up to 24 hours after intervention
New molecules involved in oxidative stress
Time frame: Up to 24 hours after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francisco de la Gala, MD, PhD principal investigator
Hospital General Universitario Gregorio Marañon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Medicinal gas - oxygen (Nippon Gases 200 bar), CPAP and Oxygen therapy according to standard clinical practice in people with Lung Resection Surgery and Anesthesia General, run by Francisco Andres de la Gala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisco de la Gala, MD, PhD (+34915868367, francisco.gala@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: Up to 30 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.