One-Lung VentilationNCT03296449
Comparison Between CPAP and HFJV During One-lung Ventilation in VATS
A study testing CPAP and HFJV in people with One-Lung Ventilation and Thoracic Surgery, Video-Assisted, run by Hospital General Universitario de Alicante at 1 site in Spain.
Trial summary
This study compares two ventilatory techniques (continuous positive airway pressure vs high frequency jet ventilation) during one-lung ventilation (OLV) in video-assisted thoracic surgery (VATS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- One-Lung Ventilation, Thoracic Surgery, Video-Assisted
- What is being tested?
- CPAP and HFJV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 22 Nov 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject requiring one-lung ventilation
- Subject under video-assisted thoracic surgery
Who cannot join
- Pregnant
- Emergent surgery
- Hemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Continuous Positive Airway Pressure and High-frequency Jet Ventilation in Nondependent Lung During One-lung Ventilation in Video-assisted Thoracoscopic Surgery
This study compares two ventilatory techniques (continuous positive airway pressure vs high frequency jet ventilation) during one-lung ventilation (OLV) in video-assisted thoracic surgery (VATS). All patients were ventilated with both ventilatory techniques and parameters of gas exchange were determined through arterial blood gas test.
Read the detailed description
One-lung ventilation is mandatory during most thoracic surgery procedures. During OLV, collapsed lung develops an intrapulmonary shunt leading to arterial hypoxemia. Since arterial hypoxemia is a critical intraoperative problem, many times , anesthesiologists have to use rescue ventilation strategies on non-dependent lung to improve arterial oxygen levels. The use of continuous positive airway pressure on non-dependent lung has become the most common technique to achieve that aim.
High-frequency jet ventilation on non-dependent lung may be considered as an alternative way of ventilation of the non-dependent lung during one-lung ventilation because it provides a suitable gaseous exchange while facilitating minimizing surgical field motion. However, this ventilation maneuver is rarely use by thoracic anesthesiologists.
Over the last years, video assisted thoracic surgery (VATS) has become widely utilized. This surgical technique becomes even more dependent on immobilization of the operation field than open-chest thoracic procedures. There is a lack of evidence in the current literature regarding the use of HFJV in VATS.
The purpose of this study is to evaluate the effects of HFJV as an alternative for the treatment of hypoxemia in VATS.
One-lung ventilation is mandatory during most thoracic surgery procedures. During OLV, collapsed lung develops an intrapulmonary shunt leading to arterial hypoxemia. Since arterial hypoxemia is a critical intraoperative problem, many times , anesthesiologists have to use rescue ventilation strategies on non-dependent lung to improve arterial oxygen levels. The use of continuous positive airway pressure on non-dependent lung has become the most common technique to achieve that aim.
High-frequency jet ventilation on non-dependent lung may be considered as an alternative way of ventilation of the non-dependent lung during one-lung ventilation because provide suitable gaseous exchange while facilitate minimizing surgical field motion. However , this ventilation maneuver is rarely use by thoracic anesthesiologists.
Over the last years, video assisted thoracic surgery (VATS) has become widely utilized. This surgical technique becomes even more dependent on immobilization of the operation field than open-chest thoracic procedures. There is a lack of evidence in the current literature about the use of HFJV in VATS.
The purpose of this study is to evaluate the effects of HFJV as an alternative for the treatment of hypoxemia in VATS.
- Being tested
- CPAP, HFJV
- Keywords
- Hypoxia, High-Frequency Jet Ventilation, Continuous Positive Airway Pressure
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPProcedure or surgery
A recruitment maneuver will be applied to the ventilated lung. Immediately continuous positive airway pressure, at a pressure of 2-3cmH2O will applied to the non-ventilated lung for 20 minutes by the Mallinckrodt Bronchocath Disposable CPAP system (a recognised anesthetic breathing system design for CPAP).
HFJVProcedure or surgery
A recruitment maneuver will be applied to the ventilated lung. Immediately, high-frequency jet ventilation, with a driving pressure of 0.5 atm and a respiratory rate of 100 cycles per minute will applied to the non-ventilated lung for 20 minutes using the Monsoone III Jet Ventilator (Acutronic, Hirzel, Switzerland). Monsoone III is a recognised ventilator design for HFJV.
| Study group | Role | What they receive |
|---|---|---|
| One-Lung Ventilation | No intervention | During one-lung ventilation, when the chest is open, the non-dependent lung is collapsed and manipulated by the surgeon. It is the routine procedure during video-assisted thoracic surgery. |
| CPAP to non-dependent lung | Active comparator | The patient will be randomly assigned to the study arm "Continuous Positive Airway Pressure (CPAP)". CPAP will be applied for 20 minutes to the non-dependent lung at a pressure of 2-3cmH20 using the disposable Mallinckrodt Bronchocath CPAP system. Receives: Procedure: CPAP |
| HFJV to non-dependent lung | Experimental | The patient is randomly assigned to the study arm "High-frequency jet ventilation (HFJV)". HFJV will be applied for 20 minutes to the non-dependent lung with a driving pressure of a 0.6 atm, respiratory rate 100 cycles per minute using the Monsoone III Jet Ventilator (Acutronic, Hirzel, Switzerland). Receives: Procedure: HFJV |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2
Ratio of the arterial oxygen partial pressure (PaO2) to the inspired oxygen fraction (FiO2) determination.
Time 0 (the patient is anesthetized and being ventilated on two lungs). Time 20 minutes (patient has been ventilated on one lung for 20 minutes). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or HFJV]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or HFJV])
Measured: 1 day
Secondary outcomes (2)
PaCO2
Arterial carbon dioxide partial pressure determination. Time 0 (the patient is anesthetized and being ventilated on two lungs). Time 20 minutes (patient has been ventilated on one lung for 20 minutes). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or HFJV]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or HFJV])
Measured: 1 day
Operative field conditions
Surgeon's subjective opinion about operating conditions during the interventions: impossible surgical access, acceptable operative filed or excellent operative field).
Time 20 minutes (patient has been ventilated on one lung for 20 minutes). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or HFJV]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or HFJV])
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start22 Nov 2017
- Primary completion29 Apr 2018
- Study completion30 Jun 2018
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario de Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Galiana Ivars, Hospital General Universitario de Alicante
- Investigators
- Maria Galiana, Principal investigator, Hospital General Universitario de Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296449
- Sponsor's protocol ID
- FREQUENCY
- Status last verified
- Feb 2019
- First submitted
- 13 Sep 2017
- Last updated
- 26 Feb 2019
- 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 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Continuous Positive Airway Pressure and High-frequency Jet Ventilation in Nondependent Lung During One-lung Ventilation in Video-assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT03296449
- Acronym / sponsor ID
- FREQUENCY
- Keywords
- Hypoxia, High-Frequency Jet Ventilation, Continuous Positive Airway Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital General Universitario de AlicanteUniversity, hospital or other
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 29 Apr 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 28 Sep 2017 (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.
This study compares two ventilatory techniques (continuous positive airway pressure vs high frequency jet ventilation) during one-lung ventilation (OLV) in video-assisted thoracic surgery (VATS). All patients were ventilated with both ventilatory techniques and parameters of gas exchange were determined through arterial blood gas test.
Detailed description
One-lung ventilation is mandatory during most thoracic surgery procedures. During OLV, collapsed lung develops an intrapulmonary shunt leading to arterial hypoxemia. Since arterial hypoxemia is a critical intraoperative problem, many times , anesthesiologists have to use rescue ventilation strategies on non-dependent lung to improve arterial oxygen levels. The use of continuous positive airway pressure on non-dependent lung has become the most common technique to achieve that aim.
High-frequency jet ventilation on non-dependent lung may be considered as an alternative way of ventilation of the non-dependent lung during one-lung ventilation because it provides a suitable gaseous exchange while facilitating minimizing surgical field motion. However, this ventilation maneuver is rarely use by thoracic anesthesiologists.
Over the last years, video assisted thoracic surgery (VATS) has become widely utilized. This surgical technique becomes even more dependent on immobilization of the operation field than open-chest thoracic procedures. There is a lack of evidence in the current literature regarding the use of HFJV in VATS.
The purpose of this study is to evaluate the effects of HFJV as an alternative for the treatment of hypoxemia in VATS.
One-lung ventilation is mandatory during most thoracic surgery procedures. During OLV, collapsed lung develops an intrapulmonary shunt leading to arterial hypoxemia. Since arterial hypoxemia is a critical intraoperative problem, many times , anesthesiologists have to use rescue ventilation strategies on non-dependent lung to improve arterial oxygen levels. The use of continuous positive airway pressure on non-dependent lung has become the most common technique to achieve that aim.
High-frequency jet ventilation on non-dependent lung may be considered as an alternative way of ventilation of the non-dependent lung during one-lung ventilation because provide suitable gaseous exchange while facilitate minimizing surgical field motion. However , this ventilation maneuver is rarely use by thoracic anesthesiologists.
Over the last years, video assisted thoracic surgery (VATS) has become widely utilized. This surgical technique becomes even more dependent on immobilization of the operation field than open-chest thoracic procedures. There is a lack of evidence in the current literature about the use of HFJV in VATS.
The purpose of this study is to evaluate the effects of HFJV as an alternative for the treatment of hypoxemia in VATS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| One-Lung Ventilation | No intervention | –During one-lung ventilation, when the chest is open, the non-dependent lung is collapsed and manipulated by the surgeon. It is the routine procedure during video-assisted thoracic surgery. |
| CPAP to non-dependent lung | Active comparator | Procedure: CPAPThe patient will be randomly assigned to the study arm "Continuous Positive Airway Pressure (CPAP)". CPAP will be applied for 20 minutes to the non-dependent lung at a pressure of 2-3cmH20 using the disposable Mallinckrodt Bronchocath CPAP system. |
| HFJV to non-dependent lung | Experimental | Procedure: HFJVThe patient is randomly assigned to the study arm "High-frequency jet ventilation (HFJV)". HFJV will be applied for 20 minutes to the non-dependent lung with a driving pressure of a 0.6 atm, respiratory rate 100 cycles per minute using the Monsoone III Jet Ventilator (Acutronic, Hirzel, Switzerland). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject requiring one-lung ventilation
- Subject under video-assisted thoracic surgery
Key exclusion criteria (3 listed)
- Pregnant
- Emergent surgery
- Hemodynamic instability
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 |
|---|---|---|
| CPAPA recruitment maneuver will be applied to the ventilated lung. Immediately continuous positive airway pressure, at a pressure of 2-3cmH2O will applied to the non-ventilated lung for 20 minutes by the Mallinckrodt Bronchocath Disposable CPAP system (a recognised anesthetic breathing system design for CPAP). | Procedure or surgery | CPAP to non-dependent lung |
| HFJVA recruitment maneuver will be applied to the ventilated lung. Immediately, high-frequency jet ventilation, with a driving pressure of 0.5 atm and a respiratory rate of 100 cycles per minute will applied to the non-ventilated lung for 20 minutes using the Monsoone III Jet Ventilator (Acutronic, Hirzel, Switzerland). Monsoone III is a recognised ventilator design for HFJV. | Procedure or surgery | HFJV to non-dependent lung |
Primary outcome
PaO2/FiO2
Time frame: 1 day
Ratio of the arterial oxygen partial pressure (PaO2) to the inspired oxygen fraction (FiO2) determination. Time 0 (the patient is anesthetized and being ventilated on two lungs). Time 20 minutes (patient has been ventilated on one lung for 20 minutes). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or HFJV]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or HFJV])
2 secondary outcomes
PaCO2
Time frame: 1 day
Operative field conditions
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: Undecided
Related trials for One-Lung Ventilation
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Flow-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Thoracic Surgery
Mechanical Ventilation, Postoperative Pulmonary Complications (PPCs)
Recruiting
BMI-Adjusted PEEP During One-Lung Ventilation in Thoracic Surgery
Pulmonary Resection Surgery, One Lung Ventillation (OLV)
Not yet recruitingObservational study
Comparison of Different Ventilation Modes in Video-Assisted Thoracoscopic Lung Resection
One-lung Ventilation (OLV), Video-assisted Thoracis Surgery (VATS)
Not yet recruiting
Brief Bronchial Suction for Lung Collapse During Uniportal VATS
Lung Collapse, One-lung Ventilation
Not yet recruiting
Video-guided Versus Conventional Right-sided Double-lumen Tube Placement for Thoracoscopic Surgery
Right-sided Double-lumen Tube Positioning, Lung Isolation During Thoracoscopic Surgery
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. This study is not recruiting at the moment.
Maria Galiana principal investigator
Hospital General Universitario de Alicante
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP and HFJV in people with One-Lung Ventilation and Thoracic Surgery, Video-Assisted, run by Hospital General Universitario de Alicante 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 26 Feb 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2/FiO2 (time frame: 1 day). 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 26 Feb 2019.