The goal of this clinical trial is to evaluate the efficacy of bronchial blockers and double-lumen tubes in achieving one-lung ventilation in obese patients undergoing lung resections. The primary question it aims to answer is: • Is intraoperative hypoxia significantly different depending on the device used? Researchers will compare the use of bronchial blockers and double-lumen tubes to assess differences in efficacy and safety. Participants will not be required to perform any tasks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
46
To achieve the required one-lung ventilation during lung resection, patients will be managed with a double-lumen tube.
To achieve the required one-lung ventilation during lung resection, patients will be managed with a bronchial blocker.
Hospital Son Espases
Palma de Mallorca, Balearic Islands, Spain
RECRUITINGHypoxia
While its definition is somewhat arbitrary, the investigators consider hypoxia as SpO₂ \< 90%, while maintaining FiO₂ = 1.0, in accordance to our hospital guidelines.
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Lung collapse
Assessed by the anaesthesiologist as: Excellent: complete lung collapse, perfect surgical visualization; Good: complete collapse, residual air; Poor: non-achieved collapse or partial collapse that interfered with surgical visualization.
Time frame: Intraoperative
Surgical visualization
Assessed by the thoracic surgeon as excellent, good or poor.
Time frame: Intraoperative
Insertion time of the ventilation device
Time in minutes from the beginning of ventilation device insertion until correct placement is confirmed.
Time frame: Intraoperative
Repositioning of the ventilation device
Number of repositioning attempts of the ventilation device.
Time frame: Intraoperative
Ventilation device change
When ventilation cannot be achieved with the device randomly allocated to the patient, conversion to the alternative device must be documented.
Time frame: Intraoperative
Techniques employed in case of hypoxia
Record of intraoperative interventions performed in response to hypoxia (defined as SpO₂ \< 90% despite FiO₂ = 1.0), including: increase in FiO₂, VENTRAIN ventilation/oxygenation, continuous positive airway pressure (CPAP) to the non-dependent lung, or temporary return to bilateral lung ventilation.
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Time frame: Intraoperative
SpO₂
Peripheral oxygen saturation, measured as a percentage.
Time frame: Preoperative and intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Ventilation mode
Type of mechanical ventilation mode applied intraoperatively, categorized as volume-controlled ventilation (VCV), pressure-controlled ventilation (PCV), or pressure-controlled ventilation with volume guarantee (PCV-VG).
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Tidal volume (Vt)
Volume of air delivered to the lungs with each ventilator breath during mechanical ventilation (mL).
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Respiratory Rate (Fr)
Number of ventilator-delivered breaths per minute (bpm) during intraoperative mechanical ventilation.
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Peak Airway pressure
Maximum pressure reached during inspiration in mechanical ventilation, reflecting resistance in the airways (cmH₂O).
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Plateau Pressure
Pressure measured during an inspiratory pause (cmH₂O).
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Driving Pressure
Difference between plateau pressure and positive end-expiratory pressure (cmH₂O).
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Fraction of Inspired Oxygen (FiO₂)
Percentage of oxygen in the gas mixture delivered by the ventilator during mechanical ventilation.
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Partial Pressure of Arterial Oxygen (PaO₂)
Measurement of arterial oxygen tension during mechanical ventilation (mmHg).
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Partial Pressure of Arterial Carbon Dioxide (PaCO₂)
Measurement of arterial carbon dioxide tension (mmHg).
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
PaO₂/FiO₂
Ratio of arterial oxygen partial pressure to the fraction of inspired oxygen.
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Hemoglobin
Arterial blood concentration of hemoglobin, collected intraoperatively as part of blood gas analysis (g/dL).
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Hematocrit
Percentage of red blood cells in whole blood, measured intraoperatively as part of arterial blood gas analysis (%).
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Intraoperative complications
Type of intraoperative complications related to the airway device, including: displacement of the bronchial blocker, tracheobronchial tree rupture, misplacement, trauma to the tracheobronchial tree, need for conversion to thoracotomy, and other complications.
Time frame: Intraoperative
Postoperative recovery complications
Incidence of complications during the immediate postoperative period, including sore throat, aphonia, and other symptoms related to airway instrumentation.
Time frame: First 24 hours after surgery