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

ConditionsLung Resection SurgeryAnesthesia General
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFrancisco Andres de la Gala

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Medicinal gas - oxygen (Nippon Gases 200 bar)

    Drug

    Medicinal gas, compressed. Oxygen 99.5% v/v

  • CPAP

    Device

    Continuous positive pressure

  • Oxygen therapy according to standard clinical practice

    Procedure/Surgery

    Ambient air connection

Treatment groups

177 Participants
are divided into 3 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: CPAP GroupExperimental treatment 1 intervention
Group C: APNEIC OXYGENATION groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Up to 30 days after intervention

Secondary outcomes

1

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

Time frame
Intraoperative period and 24 hours
2

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.

Time frame
Surgery duration; assessed at end of surgery
3

Incidence of postoperative pulmonary complications

To compare de incidence of postoperative pulmonary complications among the three study groups

Time frame
Up to 30 days after intervention
4

Special Care Units stay

To compare the length of stay in Special Care Units among the three study groups

Time frame
Up to 30 days after intervention

Other outcomes

Sponsors and contacts

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Francisco Andres de la Gala

Lead sponsor

Hospital General Universitario Gregorio Marañon

Sponsor institution

Instituto de Salud Carlos III

Collaborator

Source ClinicalTrials.gov
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