Bronchial Blockers vs Double-Lumen Tubes in Obese Patients

NCT07031986 | Recruiting

• 1 other identifier: IB 5484/24 PI
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

One-lung Ventilation

Keywords

one-lung ventilation; lung resection; bronchial blocker; double-lumen tube

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (21)

• Lung collapse

  Intraoperative

• Surgical visualization

  Intraoperative

• Insertion time of the ventilation device

  Intraoperative

• Repositioning of the ventilation device

  Intraoperative

• Ventilation device change

  Intraoperative

Other Outcomes (22)

• Sex

  Preoperative

• Age

  Preoperative

• Obesity

  Preoperative

Study Arms (2)

Bronchial Blocker

EXPERIMENTAL

Patients undergoing lung resection who receive one-lung ventilation using a bronchial blocker.

Device: One-Lung Ventilation with Bronchial Blocker

Double-Lumen Tube

EXPERIMENTAL

Patients undergoing lung resection who receive one-lung ventilation using a double-lumen tube.

Device: One-Lung ventilation with Double-Lumen Tube

Interventions

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.

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.

Bronchial Blocker

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with evident anatomic alterations, in which double-lumen tubes may be contraindicated.
• Emergency surgeries.

Sponsors & Collaborators

• Paulo Andrés Cano Jiménez: lead

Study Sites (1)

Hospital Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

RECRUITING

MeSH Terms

Interventions

One-Lung Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics

Study Officials

• Paulo Andrés Cano, MD

  Hospital Son Espases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulo Andrés Cano, MD

CONTACT

34 663693744; pauloandresc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients do not know which device will be used during their surgery, as is typical in routine clinical practice.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 22, 2025
• Study Start: August 15, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

ES (1)