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Effect of Oxygen Administration in the Non-dependent Lung on Postoperative Complications After Lung Surgery

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07461779
Enrollment
177
Registered
2026-03-10
Start date
2025-01-27
Completion date
2027-03-30
Last updated
2026-03-10

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

Conditions

Anesthesia General, Lung Resection Surgery

Keywords

Postoperative complications, Thoracic surgery

Brief 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. 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.

Interventions

DRUGMedicinal gas - oxygen (Nippon Gases 200 bar)

Medicinal gas, compressed. Oxygen 99.5% v/v

DEVICECPAP

Continuous positive pressure

PROCEDUREOxygen therapy according to standard clinical practice

Ambient air connection

Sponsors

Francisco Andres de la Gala
Lead SponsorOTHER
Instituto de Salud Carlos III
CollaboratorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

All clinical staff (thoracic surgeons, pulmonologists, ICU physicians, and any other physicians involved in assessing postoperative complications) and laboratory personnel involved in the study will be blinded to the patient's group assignment, except for the anesthesiologist responsible for the case. The sealed randomization envelope will be handed to the anesthesiologist by the operating-room nurse before the start of OLV. Likewise, those responsible for entering data into the database will be blinded to group assignment; the group will be recorded in the database only immediately prior to statistical analysis.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 * Robotic surgery * Pneumonectomy * Enrollment in another clinical trial

Design outcomes

Primary

MeasureTime frameDescription
Postoperative complicationsUp to 30 days after interventionTo compare the proportion of patients in each grade of the revised Clavien-Dindo classification for thoracic surgery across the three study groups

Secondary

MeasureTime frameDescription
Gas exchange and acid-base balanceIntraoperative period and 24 hoursTo compare gas exchange and acid-base balance during the intraoperative period and during the first 24 hours postoperatively
Degree of interference with surgical exposure (Surgeon Satisfaction Scale on Oxygen Therapy Interference, 1-5)Surgery duration; assessed at end of surgeryAssessed 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.
Incidence of postoperative pulmonary complicationsUp to 30 days after interventionTo compare de incidence of postoperative pulmonary complications among the three study groups
Special Care Units stayUp to 30 days after interventionTo compare the length of stay in Special Care Units among the three study groups
Readmisions to Special Care UnitsUp to 30 days after interventionTo compare the number of readmissions to Special Care Units among the three study groups
Hospital StayUp to 30 days after interventionTo compare the average hospital stay (measure in days) among the three study groups
Hospital readmissionUp to 30 days after interventionTo compare hospital readmissions among the three study groups
Inflammatory biomarkers in blood and bronchoalveolar lavagesUp to 24 hours after interventionTo 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
New molecules involved in oxidative stressUp to 24 hours after interventionIdentification 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.

Countries

Spain

Contacts

CONTACTFrancisco de la Gala, MD, PhD
francisco.gala@salud.madrid.org+34915868367
CONTACTIgnacio Garutti, MD
ignacio.garutti@salud.madrid.org+34915868367
PRINCIPAL_INVESTIGATORFrancisco de la Gala, MD, PhD

Hospital General Universitario Gregorio Marañón

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026