Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07031986

Bronchial Blockers vs Double-Lumen Tubes in Obese Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

Location status: Recruiting

Location contact

Paulo Andrés Cano, MD

CONTACT

[email protected]

34 663693744

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Hypoxia

    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.

Secondary outcomes

  1. Lung collapse

    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.

  2. Surgical visualization

    Time frame: Intraoperative

    Assessed by the thoracic surgeon as excellent, good or poor.

  3. Insertion time of the ventilation device

    Time frame: Intraoperative

    Time in minutes from the beginning of ventilation device insertion until correct placement is confirmed.

  4. Repositioning of the ventilation device

    Time frame: Intraoperative

    Number of repositioning attempts of the ventilation device.

  5. Ventilation device change

    Time frame: Intraoperative

    When ventilation cannot be achieved with the device randomly allocated to the patient, conversion to the alternative device must be documented.

  6. Techniques employed in case of hypoxia

    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.

  7. SpO₂

    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.

  8. Ventilation mode

    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).

  9. Tidal volume (Vt)

    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).

  10. Respiratory Rate (Fr)

    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.

  11. Peak Airway pressure

    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).

  12. Plateau Pressure

    Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)

    Pressure measured during an inspiratory pause (cmH₂O).

  13. Driving Pressure

    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).

  14. Fraction of Inspired Oxygen (FiO₂)

    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.

  15. Partial Pressure of Arterial Oxygen (PaO₂)

    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).

  16. Partial Pressure of Arterial Carbon Dioxide (PaCO₂)

    Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)

    Measurement of arterial carbon dioxide tension (mmHg).

  17. PaO₂/FiO₂

    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.

  18. Hemoglobin

    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).

  19. Hematocrit

    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 (%).

  20. Intraoperative complications

    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.

  21. Postoperative recovery 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.

Other outcomes

  1. Sex

    Time frame: Preoperative

    Male or female.

  2. Age

    Time frame: Preoperative

    Age at the time of the procedure (years).

  3. Obesity

    Time frame: Preoperative

    Categorized as: Grade I (BMI: 30-34.9); Grade II (BMI: 35-35.9); Grade III (BMI≥ 40).

  4. Charlson Comorbidity Index

    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.

  5. Smoker

    Time frame: Preoperative

    Yes or no.

  6. ASA Scale

    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.

  7. Revised Cardiac Risk Index (RCRI)

    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.

  8. Airway Assesment

    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.

  9. Alveolar recruitment maneuvers

    Time frame: Intraoperative

    Yes or no.

  10. Anesthetics

    Time frame: Intraoperative

    Halogenated or intravenous.

  11. Intubation assistance device

    Time frame: Intraoperative

    Laryngoscope or videolaryngoscope.

  12. Laryngoscopy visualization

    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).

  13. Laterality of the blockage

    Time frame: Intraoperative

    Bronchus in which the device is inserted.

  14. Mask ventilation

    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.

  15. Surgery time

    Time frame: Intraoperative

    Total surgical time in minutes, measured from the first incision to the completion of wound closure.

  16. Lung resection

    Time frame: Intraoperative

    Lobectomy, segmentectomy or wedge resection.

  17. Etiology

    Time frame: Intraoperative

    Malignant or benign lung neoplasia.

  18. VATS procedure

    Time frame: Intraoperative

    Yes or no.

  19. Thoracotomy

    Time frame: Intraoperative

    Yes or no.

  20. Patient positioning

    Time frame: Intraoperative

    Lateral, supine or prone position.

  21. DLCO

    Time frame: Preoperative

    Preoperative diffusion capacity of the lung for carbon monoxide (DLCO), expressed as a percentage of the predicted value.

  22. FEV1

    Time frame: Preoperative

    Preoperative forced expiratory volume in one second (FEV1), reported as a percentage of the predicted value.

Study contacts

Contact information is provided by the study sponsor or research team.

Paulo Andrés Cano, MD

CONTACT

[email protected]

34 663693744

Sponsors and collaborators

Lead sponsor

Paulo Andrés Cano Jiménez

Other

Registry information

Official study title

One-lung Ventilation With Double-Lumen Tubes and Bronchial Blockers in Obese Patients Undergoing Lung Resection

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2025
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.