One-lung VentilationNCT07031986
Bronchial Blockers vs Double-Lumen Tubes in Obese Patients
A study testing One-Lung ventilation with Double-Lumen Tube and One-Lung Ventilation with Bronchial Blocker in people with One-lung Ventilation, run by Paulo Andrés Cano Jiménez at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- One-lung Ventilation
- What is being tested?
- One-Lung ventilation with Double-Lumen Tube and One-Lung Ventilation with Bronchial Blocker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 15 Aug 2024to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with evident anatomic alterations, in which double-lumen tubes may be contraindicated.
- Emergency surgeries.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Son Espases
Palma de Mallorca, Balearic Islands, 07120
Paulo Andrés Cano, MD, 34 663693744, pauloandresc@gmail.com
About this study
Official title: One-lung Ventilation With Double-Lumen Tubes and Bronchial Blockers in Obese Patients Undergoing Lung Resection
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
- Being tested
- One-Lung ventilation with Double-Lumen Tube, One-Lung Ventilation with Bronchial Blocker
- Keywords
- one-lung ventilation, lung resection, bronchial blocker, double-lumen tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-Lung ventilation with Double-Lumen TubeDevice
To achieve the required one-lung ventilation during lung resection, patients will be managed with a double-lumen tube.
One-Lung Ventilation with Bronchial BlockerDevice
To achieve the required one-lung ventilation during lung resection, patients will be managed with a bronchial blocker.
| Study group | Role | What they receive |
|---|---|---|
| Bronchial Blocker | Experimental | Patients undergoing lung resection who receive one-lung ventilation using a bronchial blocker. Receives: 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. Receives: Device: One-Lung ventilation with Double-Lumen Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Secondary outcomes (21)
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.
Measured: Intraoperative
Surgical visualization
Assessed by the thoracic surgeon as excellent, good or poor.
Measured: Intraoperative
Insertion time of the ventilation device
Time in minutes from the beginning of ventilation device insertion until correct placement is confirmed.
Measured: Intraoperative
Repositioning of the ventilation device
Number of repositioning attempts of the ventilation device.
Measured: Intraoperative
Ventilation device change
When ventilation cannot be achieved with the device randomly allocated to the patient, conversion to the alternative device must be documented.
Measured: Intraoperative
Techniques employed in case of hypoxia
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.
Measured: Intraoperative
SpO₂
Peripheral oxygen saturation, measured as a percentage.
Measured: Preoperative and intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Ventilation mode
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).
Measured: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Tidal volume (Vt)
Volume of air delivered to the lungs with each ventilator breath during mechanical ventilation (mL).
Measured: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Respiratory Rate (Fr)
Number of ventilator-delivered breaths per minute (bpm) during intraoperative mechanical ventilation.
Measured: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Peak Airway pressure
Maximum pressure reached during inspiration in mechanical ventilation, reflecting resistance in the airways (cmH₂O).
Measured: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Plateau Pressure
Pressure measured during an inspiratory pause (cmH₂O).
Measured: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Driving Pressure
Difference between plateau pressure and positive end-expiratory pressure (cmH₂O).
Measured: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Fraction of Inspired Oxygen (FiO₂)
Percentage of oxygen in the gas mixture delivered by the ventilator during mechanical ventilation.
Measured: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Partial Pressure of Arterial Oxygen (PaO₂)
Measurement of arterial oxygen tension during mechanical ventilation (mmHg).
Measured: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Partial Pressure of Arterial Carbon Dioxide (PaCO₂)
Measurement of arterial carbon dioxide tension (mmHg).
Measured: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
PaO₂/FiO₂
Ratio of arterial oxygen partial pressure to the fraction of inspired oxygen.
Measured: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Hemoglobin
Arterial blood concentration of hemoglobin, collected intraoperatively as part of blood gas analysis (g/dL).
Measured: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Hematocrit
Percentage of red blood cells in whole blood, measured intraoperatively as part of arterial blood gas analysis (%).
Measured: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Intraoperative complications
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.
Measured: Intraoperative
Postoperative recovery complications
Incidence of complications during the immediate postoperative period, including sore throat, aphonia, and other symptoms related to airway instrumentation.
Measured: First 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start15 Aug 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for One-lung VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paulo Andrés Cano Jiménez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paulo Andrés Cano Jiménez, Hospital Son Espases
- Investigators
- Paulo Andrés Cano, MD, Principal investigator, Hospital Son Espases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031986
- Sponsor's protocol ID
- IB 5484/24 PI
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-lung Ventilation With Double-Lumen Tubes and Bronchial Blockers in Obese Patients Undergoing Lung Resection
- ClinicalTrials.gov ID
- NCT07031986
- Acronym / sponsor ID
- IB 5484/24 PI
- Conditions
- One-lung Ventilation
- Keywords
- one-lung ventilation, lung resection, bronchial blocker, double-lumen tube
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Paulo Andrés Cano JiménezUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bronchial Blocker | Experimental | Device: One-Lung Ventilation with Bronchial BlockerPatients undergoing lung resection who receive one-lung ventilation using a bronchial blocker. |
| Double-Lumen Tube | Experimental | Device: One-Lung ventilation with Double-Lumen TubePatients undergoing lung resection who receive one-lung ventilation using a double-lumen tube. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with evident anatomic alterations, in which double-lumen tubes may be contraindicated.
- Emergency surgeries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One-Lung ventilation with Double-Lumen TubeTo achieve the required one-lung ventilation during lung resection, patients will be managed with a double-lumen tube. | Device | Double-Lumen Tube |
| One-Lung Ventilation with Bronchial BlockerTo achieve the required one-lung ventilation during lung resection, patients will be managed with a bronchial blocker. | Device | Bronchial Blocker |
Primary outcome
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.
21 secondary outcomes
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)
Driving Pressure
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Fraction of Inspired Oxygen (FiO₂)
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Partial Pressure of Arterial Oxygen (PaO₂)
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Partial Pressure of Arterial Carbon Dioxide (PaCO₂)
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
PaO₂/FiO₂
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Hemoglobin
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Hematocrit
Time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
Intraoperative complications
Time frame: Intraoperative
Postoperative recovery complications
Time frame: First 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paulo Andrés Cano, MD principal investigator
Hospital Son Espases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-Lung ventilation with Double-Lumen Tube and One-Lung Ventilation with Bronchial Blocker in people with One-lung Ventilation, run by Paulo Andrés Cano Jiménez at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paulo Andrés Cano, MD (34 663693744, pauloandresc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxia (time frame: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.