Bronchial Blockers vs Double-Lumen Tubes in Obese Patients

ConditionOne-lung Ventilation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-90

SponsorPaulo Andrés Cano Jiménez

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Emergency surgeries.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

46 Participants

are divided into 2 treatment groups

Group A: Bronchial BlockerExperimental treatment 1 intervention

Group B: Double-Lumen TubeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

Lung collapse

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

Surgical visualization

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

Time frame

Intraoperative

Insertion time of the ventilation device

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

Time frame

Intraoperative

Repositioning of the ventilation device

Number of repositioning attempts of the ventilation device.

Time frame

Intraoperative

Other outcomes

Sex

Male or female.

Time frame

Preoperative

Age

Age at the time of the procedure (years).

Time frame

Preoperative

Obesity

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

Time frame

Preoperative

Charlson Comorbidity Index

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Paulo Andrés Cano Jiménez

Lead sponsor

Hospital Son Espases

Sponsor institution

Source ClinicalTrials.gov

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