Bronchial Blockers vs Double-Lumen Tubes in Obese Patients

Not Applicable

Recruiting

• Conditions: One-lung Ventilation

• Registration Number: NCT07031986
• Lead Sponsor: Paulo Andrés Cano Jiménez

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-15
• Status Verified: 2025-06
• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-19
• Last Update Submitted: 2025-06-19
• Study First Posted: 2025-06-22
• Last Update Posted: 2025-06-22
• Primary Completion: 2026-04
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
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.

Trial Locations

Locations (1)

Hospital Son Espases; 🇪🇸 Palma de Mallorca, Islas Baleares, Spain