Hospital Son Espases
Palma de Mallorca, Balearic Islands, 07120, Spain
Location status: Recruiting
NCT Number: NCT07031986
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Not applicable
Palma de Mallorca, Balearic Islands, 07120, Spain
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: Intraoperative
Assessed by the thoracic surgeon as excellent, good or poor.
Time frame: Intraoperative
Time in minutes from the beginning of ventilation device insertion until correct placement is confirmed.
Time frame: Intraoperative
Number of repositioning attempts of the ventilation device.
Time frame: Intraoperative
When ventilation cannot be achieved with the device randomly allocated to the patient, conversion to the alternative device must be documented.
Time frame: 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.
Time frame: Preoperative and intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Peripheral oxygen saturation, measured as a percentage.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Pressure measured during an inspiratory pause (cmH₂O).
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
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)
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)
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)
Measurement of arterial carbon dioxide tension (mmHg).
Time frame: 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.
Time frame: 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).
Time frame: 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 (%).
Time frame: 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.
Time frame: First 24 hours after surgery
Incidence of complications during the immediate postoperative period, including sore throat, aphonia, and other symptoms related to airway instrumentation.
Time frame: Preoperative
Male or female.
Time frame: Preoperative
Age at the time of the procedure (years).
Time frame: Preoperative
Categorized as: Grade I (BMI: 30-34.9); Grade II (BMI: 35-35.9); Grade III (BMI≥ 40).
Time frame: 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.
Time frame: Preoperative
Yes or no.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Intraoperative
Yes or no.
Time frame: Intraoperative
Halogenated or intravenous.
Time frame: Intraoperative
Laryngoscope or videolaryngoscope.
Time frame: 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).
Time frame: Intraoperative
Bronchus in which the device is inserted.
Time frame: 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.
Time frame: Intraoperative
Total surgical time in minutes, measured from the first incision to the completion of wound closure.
Time frame: Intraoperative
Lobectomy, segmentectomy or wedge resection.
Time frame: Intraoperative
Malignant or benign lung neoplasia.
Time frame: Intraoperative
Yes or no.
Time frame: Intraoperative
Yes or no.
Time frame: Intraoperative
Lateral, supine or prone position.
Time frame: Preoperative
Preoperative diffusion capacity of the lung for carbon monoxide (DLCO), expressed as a percentage of the predicted value.
Time frame: Preoperative
Preoperative forced expiratory volume in one second (FEV1), reported as a percentage of the predicted value.
Contact information is provided by the study sponsor or research team.
Paulo Andrés Cano Jiménez
Other
One-lung Ventilation With Double-Lumen Tubes and Bronchial Blockers in Obese Patients Undergoing Lung Resection
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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