One-Lung VentilationNCT01744886
Comparison of Oxygen Saturation During Different Intraoperative Positions
A study testing maintain oxygenation during one lung ventilation in people with One-Lung Ventilation, run by Onze Lieve Vrouw Hospital at 1 site in Belgium.
Trial summary
One-lung ventilation (OLV) during thoracic surgery and its effect on oxygen saturation has been discussed in multiple studies. Literature shows different ventilation strategies and possible hypoxemia has been attributed to several issues. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- One-Lung Ventilation
- What is being tested?
- maintain oxygenation during one lung ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2012to Sep 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing lateral decubitus lung surgery or port-access.
- American Society of Anesthesiologists Physical Status (ASA) II or III.
- Age between 18-80 years.
- Patients willing to sign consent.
Who cannot join
- Pre-existing interstitial lung disease.
- Pre-existing obstructive airway disease.
- Inability or unwillingness of study participant to give written informed consent.
- Patients expected to have a difficult intubation for anatomical reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Oxygen Saturation Between Lateral Decubitus Lung Surgery and Port Access Procedures in Dorsal Decubitus
One-lung ventilation (OLV) during thoracic surgery and its effect on oxygen saturation has been discussed in multiple studies. Literature shows different ventilation strategies and possible hypoxemia has been attributed to several issues.
Port-access cardiac surgical procedures ("key hole surgery" including mitral valve repair or prosthesis, tricuspid valve repair or prosthesis, atrial septal defect closure or a combination of these) require the use of OLV as well. Its effect on oxygen saturation has not been studied previously.
The aim of this study is to investigate the effect of extracorporeal circulation (ECC) and patient positioning on oxygen saturation and on the progress of hypoxemia throughout OLV during port-access in comparison to oxygen saturation throughout OLV during lateral decubitus thoracotomies.
Read the detailed description
OLV is a technique that allows isolation of the individual lung under anesthesia. It is required for a number of thoracic surgical procedures as well as port-access procedures.
The use of a double lumen tube allows easy switching from two-lung to single lung ventilation.
For many thoracic operations the patient will be in the lateral decubitus position. The primary physiologic change that takes place on initiation of OLV is the presence of trans-pulmonary shunting, causing impaired oxygenation and occasionally hypoxemia. The degree of shunt is reduced due to the effect of gravity which increases pulmonary blood flow to the dependent lung and it will be further decreased due to a phenomenon termed hypoxic pulmonary vasoconstriction (HPV).
Hypoxemia may occur during OLV in lateral decubitus position due to the restriction of the dependent lung expansion caused by mediastinal weight therefore leading to atelectasis. Increased ventilation pressure and lung volume of the dependent lung impedes perfusion and contributes to hypoxemia.
Presentation of hypoxemia during OLV is multifactorial. It depends on the operation side (OLV better in left thoracotomies), on preoperative lung function [best indicator = Partial Pressure of Oxygen in Arterial Blood (PaO2) divided by Fraction of Inspired Oxygen (FIO2)] and on the distribution of perfusion. The PaO2/FIO2 is the best parameter to describe the full spectrum of ventilation-perfusion abnormalities, independent of the inspired oxygen concentration level.
The patients are divided into 2 groups according to the surgical procedure as follows:
Port-access group (n=25), and lateral decubitus lung surgery group (n=25). Standard monitoring will be applied intraoperatively [electrocardiography (ECG), pulse-oxymetry (SpO2), invasive and non-invasive blood pressure]. After induction of anesthesia, an appropriately sized double lumen tube will be inserted and its position will be checked using fibroscopy. All patients will be placed on a volume controlled mode of ventilation with the following settings: tidal volume between 5 and 10 ml/kg and FIO2 at 50% and 4 cm H2O of positive end-expiratory pressure (PEEP). Respiratory frequency and tidal volume will be adjusted to maintain end-tidal carbon dioxide (ETCO2) between 30 and 40 mmHg. ETCO2 levels and SpO2 will be monitored continuously.
If SpO2 declines below 90% the ventilator settings will be adapted according to the following protocol: First the FIO2 is increased to 80%. If this is insufficient FIO2 is increased to 100%. If this remains insufficient, continuous positive airway pressure (CPAP) [5 cm water (H2O) pressure] is applied to the non-ventilated lung. If this is still insufficient the surgeon will be asked to allow for temporary recruitment of the non-ventilated lung.
- Conditions
- One-Lung Ventilation
- Being tested
- maintain oxygenation during one lung ventilation
- Keywords
- One-Lung Ventilation, Thoracic Surgical Procedures, Cardiac Surgical Procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maintain oxygenation during one lung ventilationProcedure or surgery
All study patients will be placed on a volume controlled mode of ventilation with the following settings: tidal volume between 5 and 10 ml/kg and FIO2 at 50% and 4 cm H2O PEEP. Respiratory frequency and tidal volume will be adjusted to maintain ETCO2 between 30 and 40 mmHg. ETCO2 levels and SpO2 will be monitored continuously.
If SpO2 declines below 90% the ventilator settings will be adapted according to the following protocol: First the FIO2 is increased to 80%. If this is insufficient FIO2 is increased to 100%. If this remains insufficient 5 cm H2O of CPAP is applied to the non-ventilated lung. If this is still insufficient the surgeon will be asked to allow for temporary recruitment of the non-ventilated lung.
| Study group | Role | What they receive |
|---|---|---|
| lung surgery | Active comparator | An initial baseline arterial blood gas (ABG) will be taken before anesthesia induction while breathing room air.
A second ABG will be taken on FIO2=0.5 during double lung ventilation. Then 3 ABG's will be consecutively determined each 15 min once OLV is initiated. PaO2/FIO2 is calculated on every ABG's measurement. If necessary, measures are taken to maintain oxygenation during one lung ventilation. Receives: Procedure: maintain oxygenation during one lung ventilation |
| port-access cardiac surgery | Active comparator | An initial baseline arterial blood gas (ABG) will be taken before anesthesia induction while breathing room air.
A second ABG will be taken on FIO2=0.5 during double lung ventilation. Then 3 ABG's will be consecutively determined each 15 min once OLV is initiated. PaO2/FIO2 is calculated on every ABG's measurement. In the port-access group, FIO2 is maintained on 1 after the stopping of the ECC, so PaO2 will become our only indicator for oxygenation. If necessary, measures are taken to maintain oxygenation during one lung ventilation. Receives: Procedure: maintain oxygenation during one lung ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen saturation
To compare oxygen saturation during one-lung ventilation in patients undergoing lateral decubitus for non-cardiac thoracic surgery, requiring more than 20 minutes of one-lung ventilation using double lumen intubation, versus patients undergoing port-access cardiac surgical procedures.
Measured: 20 minutes after initiation of one-lung ventilation
Secondary outcomes (1)
oxygen saturation
To assess if oxygen saturation during one-lung ventilation depends on patient positioning.
Measured: 15 minutes of one-lung ventilation after patient positioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: Inacceptable oxygen saturation values in one study group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy CAMMU, Onze Lieve Vrouw Hospital
- Investigators
- José Coddens, MD, Study chair, OLV Hospital Aalst, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744886
- Sponsor's protocol ID
- B126201215656
- Status last verified
- Oct 2014
- First submitted
- 6 Dec 2012
- Last updated
- 17 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Watanabe S, Noguchi E, Yamada S, Hamada N, Kano T. Sequential changes of arterial oxygen tension in the supine position during one-lung ventilation. Anesth Analg. 2000 Jan;90(1):28-34. doi: 10.1097/00000539-200001000-00007.
PubMed 10624971Karzai W, Schwarzkopf K. Hypoxemia during one-lung ventilation: prediction, prevention, and treatment. Anesthesiology. 2009 Jun;110(6):1402-11. doi: 10.1097/ALN.0b013e31819fb15d.
PubMed 19417615
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Oxygen Saturation Between Lateral Decubitus Lung Surgery and Port Access Procedures in Dorsal Decubitus
- ClinicalTrials.gov ID
- NCT01744886
- Acronym / sponsor ID
- B126201215656
- Conditions
- One-Lung Ventilation
- Keywords
- One-Lung Ventilation, Thoracic Surgical Procedures, Cardiac Surgical Procedures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inacceptable oxygen saturation values in one study group
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Onze Lieve Vrouw HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 7 Dec 2012 (estimated)
- 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 (OLV) during thoracic surgery and its effect on oxygen saturation has been discussed in multiple studies. Literature shows different ventilation strategies and possible hypoxemia has been attributed to several issues.
Port-access cardiac surgical procedures ("key hole surgery" including mitral valve repair or prosthesis, tricuspid valve repair or prosthesis, atrial septal defect closure or a combination of these) require the use of OLV as well. Its effect on oxygen saturation has not been studied previously.
The aim of this study is to investigate the effect of extracorporeal circulation (ECC) and patient positioning on oxygen saturation and on the progress of hypoxemia throughout OLV during port-access in comparison to oxygen saturation throughout OLV during lateral decubitus thoracotomies.
Detailed description
OLV is a technique that allows isolation of the individual lung under anesthesia. It is required for a number of thoracic surgical procedures as well as port-access procedures.
The use of a double lumen tube allows easy switching from two-lung to single lung ventilation.
For many thoracic operations the patient will be in the lateral decubitus position. The primary physiologic change that takes place on initiation of OLV is the presence of trans-pulmonary shunting, causing impaired oxygenation and occasionally hypoxemia. The degree of shunt is reduced due to the effect of gravity which increases pulmonary blood flow to the dependent lung and it will be further decreased due to a phenomenon termed hypoxic pulmonary vasoconstriction (HPV).
Hypoxemia may occur during OLV in lateral decubitus position due to the restriction of the dependent lung expansion caused by mediastinal weight therefore leading to atelectasis. Increased ventilation pressure and lung volume of the dependent lung impedes perfusion and contributes to hypoxemia.
Presentation of hypoxemia during OLV is multifactorial. It depends on the operation side (OLV better in left thoracotomies), on preoperative lung function [best indicator = Partial Pressure of Oxygen in Arterial Blood (PaO2) divided by Fraction of Inspired Oxygen (FIO2)] and on the distribution of perfusion. The PaO2/FIO2 is the best parameter to describe the full spectrum of ventilation-perfusion abnormalities, independent of the inspired oxygen concentration level.
The patients are divided into 2 groups according to the surgical procedure as follows:
Port-access group (n=25), and lateral decubitus lung surgery group (n=25). Standard monitoring will be applied intraoperatively [electrocardiography (ECG), pulse-oxymetry (SpO2), invasive and non-invasive blood pressure]. After induction of anesthesia, an appropriately sized double lumen tube will be inserted and its position will be checked using fibroscopy. All patients will be placed on a volume controlled mode of ventilation with the following settings: tidal volume between 5 and 10 ml/kg and FIO2 at 50% and 4 cm H2O of positive end-expiratory pressure (PEEP). Respiratory frequency and tidal volume will be adjusted to maintain end-tidal carbon dioxide (ETCO2) between 30 and 40 mmHg. ETCO2 levels and SpO2 will be monitored continuously.
If SpO2 declines below 90% the ventilator settings will be adapted according to the following protocol: First the FIO2 is increased to 80%. If this is insufficient FIO2 is increased to 100%. If this remains insufficient, continuous positive airway pressure (CPAP) [5 cm water (H2O) pressure] is applied to the non-ventilated lung. If this is still insufficient the surgeon will be asked to allow for temporary recruitment of the non-ventilated lung.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lung surgery | Active comparator | Procedure: maintain oxygenation during one lung ventilationAn initial baseline arterial blood gas (ABG) will be taken before anesthesia induction while breathing room air. A second ABG will be taken on FIO2=0.5 during double lung ventilation. Then 3 ABG's will be consecutively determined each 15 min once OLV is initiated. PaO2/FIO2 is calculated on every ABG's measurement. If necessary, measures are taken to maintain oxygenation during one lung ventilation. |
| port-access cardiac surgery | Active comparator | Procedure: maintain oxygenation during one lung ventilationAn initial baseline arterial blood gas (ABG) will be taken before anesthesia induction while breathing room air. A second ABG will be taken on FIO2=0.5 during double lung ventilation. Then 3 ABG's will be consecutively determined each 15 min once OLV is initiated. PaO2/FIO2 is calculated on every ABG's measurement. In the port-access group, FIO2 is maintained on 1 after the stopping of the ECC, so PaO2 will become our only indicator for oxygenation. If necessary, measures are taken to maintain oxygenation during one lung ventilation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing lateral decubitus lung surgery or port-access.
- American Society of Anesthesiologists Physical Status (ASA) II or III.
- Age between 18-80 years.
- Patients willing to sign consent.
Key exclusion criteria (4 listed)
- Pre-existing interstitial lung disease.
- Pre-existing obstructive airway disease.
- Inability or unwillingness of study participant to give written informed consent.
- Patients expected to have a difficult intubation for anatomical reasons.
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 |
|---|---|---|
| maintain oxygenation during one lung ventilationAll study patients will be placed on a volume controlled mode of ventilation with the following settings: tidal volume between 5 and 10 ml/kg and FIO2 at 50% and 4 cm H2O PEEP. Respiratory frequency and tidal volume will be adjusted to maintain ETCO2 between 30 and 40 mmHg. ETCO2 levels and SpO2 will be monitored continuously. If SpO2 declines below 90% the ventilator settings will be adapted according to the following protocol: First the FIO2 is increased to 80%. If this is insufficient FIO2 is increased to 100%. If this remains insufficient 5 cm H2O of CPAP is applied to the non-ventilated lung. If this is still insufficient the surgeon will be asked to allow for temporary recruitment of the non-ventilated lung. | Procedure or surgery | lung surgery, port-access cardiac surgery |
Primary outcome
oxygen saturation
Time frame: 20 minutes after initiation of one-lung ventilation
To compare oxygen saturation during one-lung ventilation in patients undergoing lateral decubitus for non-cardiac thoracic surgery, requiring more than 20 minutes of one-lung ventilation using double lumen intubation, versus patients undergoing port-access cardiac surgical procedures.
1 secondary outcome
oxygen saturation
Time frame: 15 minutes of one-lung ventilation after patient positioning
Results and safety
The study was stopped early (reason given: Inacceptable oxygen saturation values in one study group). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2014.
- Background: PubMed 10624971Watanabe S, Noguchi E, Yamada S, Hamada N, Kano T. Sequential changes of arterial oxygen tension in the supine position during one-lung ventilation. Anesth Analg. 2000 Jan;90(1):28-34. doi: 10.1097/00000539-200001000-00007.
- Background: PubMed 19417615Karzai W, Schwarzkopf K. Hypoxemia during one-lung ventilation: prediction, prevention, and treatment. Anesthesiology. 2009 Jun;110(6):1402-11. doi: 10.1097/ALN.0b013e31819fb15d.
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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. This study is not recruiting at the moment.
José Coddens, MD study chair
OLV Hospital Aalst, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maintain oxygenation during one lung ventilation in people with One-Lung Ventilation, run by Onze Lieve Vrouw Hospital at 1 site in Belgium.
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 4 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: stopped early, as of the sponsor's last update on 17 Oct 2014. 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 Belgium. 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 was stopped early (reason given: Inacceptable oxygen saturation values in one study group). Results are not available in the source record.
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?
oxygen saturation (time frame: 20 minutes after initiation of one-lung ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01744886, which also lists 2 linked publications.
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 17 Oct 2014.