One-lung Ventilation
Conditions
Keywords
one-lung ventilation, lung resection, bronchial blocker, double-lumen tube
Brief summary
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.
Interventions
DEVICEOne-Lung ventilation with Double-Lumen Tube
To achieve the required one-lung ventilation during lung resection, patients will be managed with a double-lumen tube.
DEVICEOne-Lung Ventilation with Bronchial Blocker
To achieve the required one-lung ventilation during lung resection, patients will be managed with a bronchial blocker.
Sponsors
Paulo Andrés Cano Jiménez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Patients do not know which device will be used during their surgery, as is typical in routine clinical practice.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* BMI ≥ 30 kg/m2 * Diagnostic or clinical suspicion of lung cancer * Lung resection surgery (lobectomy, segmentectomy or wedge resection) by VATS or thoracotomy, requiring one-lung ventilation. * Use of bronchial blocker or double-lumen tube for one-lung ventilation.
Exclusion criteria
* Patients with evident anatomic alterations, in which double-lumen tubes may be contraindicated. * Emergency surgeries.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoxia | Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation) | While its definition is somewhat arbitrary, the investigators consider hypoxia as SpO₂ \< 90%, while maintaining FiO₂ = 1.0, in accordance to our hospital guidelines. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PaO₂/FiO₂ | Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation) | Ratio of arterial oxygen partial pressure to the fraction of inspired oxygen. |
| Lung collapse | Intraoperative | 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. |
| Surgical visualization | Intraoperative | Assessed by the thoracic surgeon as excellent, good or poor. |
| Insertion time of the ventilation device | Intraoperative | Time in minutes from the beginning of ventilation device insertion until correct placement is confirmed. |
| Repositioning of the ventilation device | Intraoperative | Number of repositioning attempts of the ventilation device. |
| Ventilation device change | Intraoperative | When ventilation cannot be achieved with the device randomly allocated to the patient, conversion to the alternative device must be documented. |
| Techniques employed in case of hypoxia | Intraoperative | 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. |
| SpO₂ | Preoperative and intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation) | Peripheral oxygen saturation, measured as a percentage. |
| Ventilation mode | Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation) | 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). |
| Tidal volume (Vt) | Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation) | Volume of air delivered to the lungs with each ventilator breath during mechanical ventilation (mL). |
| Respiratory Rate (Fr) | Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation) | Number of ventilator-delivered breaths per minute (bpm) during intraoperative mechanical ventilation. |
| Peak Airway pressure | Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation) | Maximum pressure reached during inspiration in mechanical ventilation, reflecting resistance in the airways (cmH₂O). |
| Plateau Pressure | Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation) | Pressure measured during an inspiratory pause (cmH₂O). |
| Driving Pressure | Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation) | Difference between plateau pressure and positive end-expiratory pressure (cmH₂O). |
| Fraction of Inspired Oxygen (FiO₂) | Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation) | Percentage of oxygen in the gas mixture delivered by the ventilator during mechanical ventilation. |
| Partial Pressure of Arterial Oxygen (PaO₂) | Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation) | Measurement of arterial oxygen tension during mechanical ventilation (mmHg). |
| Partial Pressure of Arterial Carbon Dioxide (PaCO₂) | Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation) | Measurement of arterial carbon dioxide tension (mmHg). |
| Hemoglobin | Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation) | Arterial blood concentration of hemoglobin, collected intraoperatively as part of blood gas analysis (g/dL). |
| Hematocrit | Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation) | Percentage of red blood cells in whole blood, measured intraoperatively as part of arterial blood gas analysis (%). |
| Intraoperative complications | Intraoperative | 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. |
| Postoperative recovery complications | First 24 hours after surgery | Incidence of complications during the immediate postoperative period, including sore throat, aphonia, and other symptoms related to airway instrumentation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sex | Preoperative | Male or female. |
| Age | Preoperative | Age at the time of the procedure (years). |
| Obesity | Preoperative | Categorized as: Grade I (BMI: 30-34.9); Grade II (BMI: 35-35.9); Grade III (BMI≥ 40). |
| Charlson Comorbidity Index | Preoperative | 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. |
| Smoker | Preoperative | Yes or no. |
| ASA Scale | Preoperative | 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. |
| Revised Cardiac Risk Index (RCRI) | Preoperative | 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. |
| Airway Assesment | Preoperative | 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. |
| Alveolar recruitment maneuvers | Intraoperative | Yes or no. |
| Anesthetics | Intraoperative | Halogenated or intravenous. |
| Intubation assistance device | Intraoperative | Laryngoscope or videolaryngoscope. |
| Laryngoscopy visualization | Intraoperative | 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). |
| Laterality of the blockage | Intraoperative | Bronchus in which the device is inserted. |
| Mask ventilation | Intraoperative | 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. |
| Surgery time | Intraoperative | Total surgical time in minutes, measured from the first incision to the completion of wound closure. |
| Lung resection | Intraoperative | Lobectomy, segmentectomy or wedge resection. |
| Etiology | Intraoperative | Malignant or benign lung neoplasia. |
| VATS procedure | Intraoperative | Yes or no. |
| Thoracotomy | Intraoperative | Yes or no. |
| Patient positioning | Intraoperative | Lateral, supine or prone position. |
| DLCO | Preoperative | Preoperative diffusion capacity of the lung for carbon monoxide (DLCO), expressed as a percentage of the predicted value. |
| FEV1 | Preoperative | Preoperative forced expiratory volume in one second (FEV1), reported as a percentage of the predicted value. |
Countries
Spain
Contacts
Primary ContactPaulo Andrés Cano, MD
Outcome results
None listed