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Recruiting NCT07031986

Bronchial Blockers vs Double-Lumen Tubes in Obese Patients

No phase Interventional One-lung Ventilation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: One-Lung ventilation with Double-Lumen Tube, One-Lung Ventilation with Bronchial Blocker.
Who it may be relevant to
Registry conditions: One-lung Ventilation. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device One-Lung ventilation with Double-Lumen Tube
    To achieve the required one-lung ventilation during lung resection, patients will be managed with a double-lumen tube.
  • Device One-Lung Ventilation with Bronchial Blocker
    To achieve the required one-lung ventilation during lung resection, patients will be managed with a bronchial blocker.

Primary outcome measures

  • Hypoxia [Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)]
Secondary outcome measures (12)
  • Lung collapse [Time frame: Intraoperative]
  • Surgical visualization [Time frame: Intraoperative]
  • Insertion time of the ventilation device [Time frame: Intraoperative]
  • Repositioning of the ventilation device [Time frame: Intraoperative]
  • Ventilation device change [Time frame: Intraoperative]
  • Techniques employed in case of hypoxia [Time frame: Intraoperative]
  • SpO₂ [Time frame: Preoperative and intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)]
  • Ventilation mode [Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)]
  • Tidal volume (Vt) [Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)]
  • Respiratory Rate (Fr) [Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)]
  • Peak Airway pressure [Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)]
  • Plateau Pressure [Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Spain · 1 center
  • Hospital Son Espases — Palma de Mallorca

Identifiers

NCT: NCT07031986 · IB 5484/24 PI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗