ThoracicNCT07099963
Frequency and Severity of Respiratory Acidosis During One-lung Ventilation, a Retrospective Pilot Study to Compare Clinician Settings and Those Proposed by the VentilO Application
An observational study of Thoracic and Surgery, run by Laval University at 1 site in Canada.
Trial summary
One-lung ventilation is a mechanical ventilation method frequently used during several thoracic surgeries. One-lung ventilation requires the use of protective ventilation to limit ventilator-induced injury and reduce postoperative respiratory complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic, Surgery, Mechanical Ventilation
- What is being tested?
- one lung ventilation
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2025to Jun 2026
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patient undergoing thoracic surgery requiring intraoperative one-lung ventilation
Who may be able to join
- Adults (≥ 18 years old)
- Patients intubated and undergoing one-lung ventilation during thoracic surgery
- Volume-controlled ventilation mode used intraoperatively
Who cannot join
- Arterial blood gas data unavailable during one-lung ventilation
- Missing demographic data (sex, height, actual weight)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, G1V4G5
Francois Lellouche, 418-656-8711, francois.lellouche@criucpq.ulaval.ca
About this study
One-lung ventilation is a mechanical ventilation method frequently used during several thoracic surgeries. One-lung ventilation requires the use of protective ventilation to limit ventilator-induced injury and reduce postoperative respiratory complications. Protective ventilation during one-lung ventilation is specific since tidal volumes are applied by definition to one lung, and it is recommended to use lower tidal volumes, down to 4 ml/kg of ideal body weight. This approach requires individualized ventilation parameters, which differs from the conventional or two-lung ventilation, and there are no clear recommendations regarding respiratory rate adjustment to ensure adequate gas exchange.
Read the detailed description
The aim of the study is to:
- Evaluate whether the initial ventilation settings (tidal volume and respiratory rate) during one-lung ventilation are appropriate to prevent respiratory acidosis.
- Compare the ventilation settings (tidal volume and respiratory rate) made by clinicians with those proposed by an smartphone application ''VentilO''.
- Conditions
- Thoracic, Surgery, Mechanical Ventilation, Hypercapnia, Acidosis, One Lung Ventillation (OLV)
- Being tested
- one lung ventilation
- Medical subject headings
- Hypercapnia, Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one lung ventilationOther
Arterial blood gases during one lung ventilation
| Study group | Role | What they receive |
|---|---|---|
| Thoracic surgery | Patient managed with one lung ventilation Receives: Other: one lung ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory acidosis
The frequency of respiratory acidosis on arterial blood gases after 20 minutes of mechanical ventilation (pH < 7.35 and PaCO2 > 45mmHg) measured by arterial blood gases
Measured: 20 minutes after initiation of one lung ventilation after lung isolation
Secondary outcomes (6)
Respiratory rate
Respiratory rate set by the doctor, this respiratory rate will be compared to the suggestion of the algorithm
Measured: At the beginning of one lung ventilation during the surgery
Acid-base disorder
Presence of Respiratory alkalosis define by pH>7.45 and PaCO2 < 35 mmHg
Measured: At the beginning of one lung ventilation during the surgery
Number of participants with hemodynamic shock - hypotension
Requiring >1L of volume repletion and/or use of amines at >0.05 mcg/kg/min or norepinephrine equivalent
Measured: Day 1
Hospital length of stay
Recovery room admission through hospital discharge
Measured: Up to 90 days
Mechanical Ventilation duration
Time spent with invasive mechanical ventilation during surgery and hospital stay
Measured: Up to 90 days
Hospital mortality
Occurence of death during hospital stay
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Aug 2025
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThoracicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, François Lellouche, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099963
- Sponsor's protocol ID
- 2026-4405
- Status last verified
- Aug 2025
- First submitted
- 2 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Severity of Respiratory Acidosis During One-lung Ventilation, a Retrospective Pilot Study to Compare Clinician Settings and Those Proposed by the VentilO Application
- ClinicalTrials.gov ID
- NCT07099963
- Acronym / sponsor ID
- 2026-4405
- Conditions
- Thoracic, Surgery, Mechanical Ventilation, Hypercapnia, Acidosis, One Lung Ventillation (OLV)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 1 Aug 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.
One-lung ventilation is a mechanical ventilation method frequently used during several thoracic surgeries. One-lung ventilation requires the use of protective ventilation to limit ventilator-induced injury and reduce postoperative respiratory complications. Protective ventilation during one-lung ventilation is specific since tidal volumes are applied by definition to one lung, and it is recommended to use lower tidal volumes, down to 4 ml/kg of ideal body weight. This approach requires individualized ventilation parameters, which differs from the conventional or two-lung ventilation, and there are no clear recommendations regarding respiratory rate adjustment to ensure adequate gas exchange.
Detailed description
The aim of the study is to:
- Evaluate whether the initial ventilation settings (tidal volume and respiratory rate) during one-lung ventilation are appropriate to prevent respiratory acidosis.
- Compare the ventilation settings (tidal volume and respiratory rate) made by clinicians with those proposed by an smartphone application ''VentilO''.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracic surgery | – | Other: one lung ventilationPatient managed with one lung ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient undergoing thoracic surgery requiring intraoperative one-lung ventilation
Key inclusion criteria (3 listed)
- Adults (≥ 18 years old)
- Patients intubated and undergoing one-lung ventilation during thoracic surgery
- Volume-controlled ventilation mode used intraoperatively
Key exclusion criteria (2 listed)
- Arterial blood gas data unavailable during one-lung ventilation
- Missing demographic data (sex, height, actual weight)
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 ventilationArterial blood gases during one lung ventilation | Other | Thoracic surgery |
Primary outcome
Respiratory acidosis
Time frame: 20 minutes after initiation of one lung ventilation after lung isolation
The frequency of respiratory acidosis on arterial blood gases after 20 minutes of mechanical ventilation (pH < 7.35 and PaCO2 > 45mmHg) measured by arterial blood gases
6 secondary outcomes
Respiratory rate
Time frame: At the beginning of one lung ventilation during the surgery
Acid-base disorder
Time frame: At the beginning of one lung ventilation during the surgery
Number of participants with hemodynamic shock - hypotension
Time frame: Day 1
Hospital length of stay
Time frame: Up to 90 days
Mechanical Ventilation duration
Time frame: Up to 90 days
Hospital mortality
Time frame: Up to 90 days
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 6 Aug 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic and Surgery, run by Laval University at 1 site in Canada.
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 3 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 6 Aug 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 Canada. 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 Francois Lellouche (1-418-656-8711, francois.lellouche@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory acidosis (time frame: 20 minutes after initiation of one lung ventilation after lung isolation). 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 6 Aug 2025.