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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bronchial Blocker | Experimental | Patients undergoing lung resection who receive one-lung ventilation using a bronchial blocker. |
|
| Double-Lumen Tube | Experimental | Patients undergoing lung resection who receive one-lung ventilation using a double-lumen tube. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One-Lung ventilation with Double-Lumen Tube | Device | To achieve the required one-lung ventilation during lung resection, patients will be managed with a double-lumen tube. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypoxia | While its definition is somewhat arbitrary, the investigators consider hypoxia as SpO₂ < 90%, while maintaining FiO₂ = 1.0, in accordance to our hospital guidelines. | Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intraoperative |
| Surgical visualization |
| Measure | Description | Time Frame |
|---|---|---|
| Sex | Male or female. | Preoperative |
| Age | Age at the time of the procedure (years). | Preoperative |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paulo Andrés Cano, MD | Contact | 34 663693744 | pauloandresc@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Paulo Andrés Cano, MD | Hospital Son Espases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Son Espases | Recruiting | Palma de Mallorca | Balearic Islands | 07120 | Spain |
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| ID | Term |
|---|---|
| D061810 | One-Lung Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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Patients will be randomly allocated to one of two one-lung ventilation groups. The study focuses on intraoperative ventilation during lung resection; therefore, no follow-up is planned. The study concludes for each patient at the end of the surgery.
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Patients do not know which device will be used during their surgery, as is typical in routine clinical practice.
| One-Lung Ventilation with Bronchial Blocker | Device | To achieve the required one-lung ventilation during lung resection, patients will be managed with a bronchial blocker. |
|
Assessed by the thoracic surgeon as excellent, good or poor. |
| Intraoperative |
| Insertion time of the ventilation device | Time in minutes from the beginning of ventilation device insertion until correct placement is confirmed. | Intraoperative |
| Repositioning of the ventilation device | Number of repositioning attempts of the ventilation device. | 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. | 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. | Intraoperative |
| SpO₂ | Peripheral oxygen saturation, measured as a percentage. | 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). | 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). | 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. | 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). | Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation) |
| Plateau Pressure | Pressure measured during an inspiratory pause (cmH₂O). | 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). | 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. | 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). | 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). | 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. | 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). | 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 (%). | 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. | Intraoperative |
| Postoperative recovery complications | Incidence of complications during the immediate postoperative period, including sore throat, aphonia, and other symptoms related to airway instrumentation. | First 24 hours after surgery |
| Obesity | Categorized as: Grade I (BMI: 30-34.9); Grade II (BMI: 35-35.9); Grade III (BMI≥ 40). | Preoperative |
| Charlson Comorbidity Index | The Charlson Comorbidity Index (CCI) is a validated scoring system used to predict 10-year mortality by assigning weighted scores to 19 comorbid conditions, based on their severity. The total score reflects both the number and seriousness of comorbid diseases, with higher scores indicating a greater comorbidity burden. Values range from 0 to 33. | Preoperative |
| Smoker | Yes or no. | Preoperative |
| ASA Scale | The American Society of Anesthesiologists (ASA) Physical Status Classification assesses the preoperative health status of patients undergoing surgery: ASA I: Normal health; ASA II: Mild systemic disease; ASA III: Severe systemic disease; ASA IV: Severe systemic disease that is constant threat to life; ASA V: Moribund, not expected to survive without operation; ASA VI: Declared brain-dead. | Preoperative |
| Revised Cardiac Risk Index (RCRI) | The Revised Cardiac Risk Index (RCRI) estimates a patient's risk of perioperative cardiac complications. It is calculated based patient's comorbidities and the type of surgery. A score from 0 to 6 is assigned based on the number of risk factors present. | Preoperative |
| Airway Assesment | Assessed by El-Ganzouri Risk Index, which categorizes the risk of a difficult airway (low or high) by taking into account mouth opening, tyromental distance, Mallampati classification, cervical mobility, pronation, weight and difficult intubation history. | Preoperative |
| Alveolar recruitment maneuvers | Yes or no. | Intraoperative |
| Anesthetics | Halogenated or intravenous. | Intraoperative |
| Intubation assistance device | Laryngoscope or videolaryngoscope. | Intraoperative |
| Laryngoscopy visualization | Cormack-Lehane scale: Grade I (complete visualization of vocal chords); Grade II (partial visualization of vocal chords); Grade III (epiglottis visualization, no visualization of vocal chords); Grade IV (no visualization of epiglottis). | Intraoperative |
| Laterality of the blockage | Bronchus in which the device is inserted. | Intraoperative |
| Mask ventilation | Han Scale: Grade 0: no mask ventilation; Grade 1: Easy mask ventilation; Grade 2: Needs oral airway or adjuvant with or without neuromuscular blocking agents; Grade 3: Difficult - inadequate or unstable or requiring two care providers, with or without neuromuscular blocking agents; Grade 4: Impossible - unable to mask ventilate with or without neuromuscular blocking agents. | Intraoperative |
| Surgery time | Total surgical time in minutes, measured from the first incision to the completion of wound closure. | Intraoperative |
| Lung resection | Lobectomy, segmentectomy or wedge resection. | Intraoperative |
| Etiology | Malignant or benign lung neoplasia. | Intraoperative |
| VATS procedure | Yes or no. | Intraoperative |
| Thoracotomy | Yes or no. | Intraoperative |
| Patient positioning | Lateral, supine or prone position. | Intraoperative |
| DLCO | Preoperative diffusion capacity of the lung for carbon monoxide (DLCO), expressed as a percentage of the predicted value. | Preoperative |
| FEV1 | Preoperative forced expiratory volume in one second (FEV1), reported as a percentage of the predicted value. | Preoperative |