Lung CancerNCT03804398
Effect of Optimal Positive End-Expiratory Pressure on Oxygenation and Intrapulmonary Shunt During One-lung Ventilation
A study testing compliance guided an optimal Positive End-Expiratory Pressure and PEEP level of 5 cmH2O in people with Lung Cancer, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
To observe the effect of compliance guided an optimal Positive End-Expiratory Pressure（PEEP）on arterial oxygenation and intrapulmonary shunt during one-lung ventilation(OLV)，and discuss the lung protective effect of optimal PEEP during one-lung ventilation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- compliance guided an optimal Positive End-Expiratory Pressure and PEEP level of 5 cmH2O
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2018to 1 Nov 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 yr to 65 yr
- Body mass index(BMI)18-28kg/m2
- American Society of Anesthesiologists Physical Status Classifications I to II
- Normal cardiac and pulmonary function
- Diagnosed with uncomplicated lung cancer and was to receive video-assist thoracoscopic lobectomy under general anesthesia.
Who cannot join
- Forced expiratory volume at one second/forced vital capacity <70%
- Asthma
- Chronic obstructive pulmonary disease
- Acute lung infection
- Past history of thoracic surgery
- Cardiac,hepatic,renal and endocrine diseases
Show all 12Show fewer
- Preoperative glucocorticoid medication
- Preoperative chemotherapy
- Peripheral oxygen saturation（SpO2） kept below 90% for more than 10 minutes during operation
- Blood transfusion during operation
- Duration of one-lung ventilation less than an hour
- Occurrence of severe complications like allergic shock
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Compliance Guided an Optimal Positive End-Expiratory Pressure on Arterial Oxygenation and Intrapulmonary Shunt During One-lung Ventilation
To observe the effect of compliance guided an optimal Positive End-Expiratory Pressure（PEEP）on arterial oxygenation and intrapulmonary shunt during one-lung ventilation(OLV)，and discuss the lung protective effect of optimal PEEP during one-lung ventilation.
Read the detailed description
Sixty patients undergoing thoracic surgery were randomly allocated to the study or control group.Patients were monitored for electrocardiogram, pulse oximetry, and non-invasive blood pressure,20 gauge cannula needle for radial artery catheterization under local anesthesia, monitoring ABP.,the right subclavian vein was selected for catheterization under local anesthesia,monitoring CVP.Anesthesia was induced with sufentanil 0.4 μg/kg, propofol 2 mg/kg, and cisatracurium 0.3 mg/kg.The trachea was intubated with a double-lumen tube (DLT)，37F for male and 35F for female patients.Tube position was confirmed by bronchoscopy in the supine and lateral positions.Anesthesia was maintained with sevoflurane 1.0-1.5 vol%，propofol 2-4 mg/(kg·h) and remifentanil 0.1-0.2 μg/(kg·min) and intermittent cisatracurium 0.06-0.1 mg/kg.The lungs were initially ventilated using a volume-controlled ventilation mode,two-lung ventilation(TLV):tidal volume (VT) 8 ml/kg,respiratory rate 12-14 bpm, inspiratory:expiratory (I:E) ratio 1:2, in 60% oxygen without PEEP. During OLV, VT was reduced to 6 ml/kg,OLV was initiated at the moment of skin incision.Both groups received an alveolar recruitment maneuver(increase inspiratory pressure to 30cmH2O for 10s) at the 10min after one-lung ventilation. After the alveolar recruitment maneuver,the study group titrate PEEP from 4cmH2O,increased in 2cmH2O steps and hold at each step for 1min,and the static pulmonary compliance(Cst) would be record.Optimal PEEP was determined until the maximal static pulmonary compliance was obtained.In the control group at PEEP level of 5 cmH2O was established and maintained during the study period.Blood gas analyses, respiratory variables, and hemodynamic variables were recorded at 6 different time points:10 min after TLV(T0), 10min after OLV(T1), 30min after PEEP(T2), 60min after PEEP(T3), 10min after the end OLV(T4) and 20min after extubation(T5).
- Conditions
- Lung Cancer
- Being tested
- compliance guided an optimal Positive End-Expiratory Pressure, PEEP level of 5 cmH2O
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compliance guided an optimal Positive End-Expiratory PressureDevice
The study groups received an alveolar recruitment maneuver(increase inspiratory pressure to 30cmH2O for 10s) at the 10min after one-lung ventilation. After the alveolar recruitment maneuver,the study group titrate PEEP from 4cmH2O,increased in 2cmH2O steps and hold at each step for 1min,and the static pulmonary compliance(Cst) would be record.Optimal PEEP was determined until the maximal static pulmonary compliance was obtained.
PEEP level of 5 cmH2ODevice
In the control group at PEEP level of 5 cmH2O was established and maintained during the study period
| Study group | Role | What they receive |
|---|---|---|
| optimal PEEP group | Experimental | The study group titrate PEEP from 4cmH2O,increased in 2cmH2O steps and hold at each step for 1min,and the static pulmonary compliance(Cst) would be record.Optimal PEEP was determined until the maximal static pulmonary compliance was obtained Receives: Device: compliance guided an optimal Positive End-Expiratory Pressure |
| PEEP level of 5 cmH2O group | Active comparator | In the control group at PEEP level of 5 cmH2O was established and maintained during the study period Receives: Device: PEEP level of 5 cmH2O |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial oxygenation
To observe the effect of compliance guided an optimal Positive End-Expiratory Pressure（PEEP）on arterial oxygenation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start14 Jun 2018
- Primary completion11 Oct 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenhua chen, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804398
- Sponsor's protocol ID
- FujianUnionAnethesiaOne
- Status last verified
- Jan 2019
- First submitted
- 10 Jan 2019
- Last updated
- 15 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Compliance Guided an Optimal Positive End-Expiratory Pressure on Arterial Oxygenation and Intrapulmonary Shunt During One-lung Ventilation
- ClinicalTrials.gov ID
- NCT03804398
- Acronym / sponsor ID
- FujianUnionAnethesiaOne
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 11 Oct 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 15 Jan 2019 (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.
To observe the effect of compliance guided an optimal Positive End-Expiratory Pressure（PEEP）on arterial oxygenation and intrapulmonary shunt during one-lung ventilation(OLV)，and discuss the lung protective effect of optimal PEEP during one-lung ventilation.
Detailed description
Sixty patients undergoing thoracic surgery were randomly allocated to the study or control group.Patients were monitored for electrocardiogram, pulse oximetry, and non-invasive blood pressure,20 gauge cannula needle for radial artery catheterization under local anesthesia, monitoring ABP.,the right subclavian vein was selected for catheterization under local anesthesia,monitoring CVP.Anesthesia was induced with sufentanil 0.4 μg/kg, propofol 2 mg/kg, and cisatracurium 0.3 mg/kg.The trachea was intubated with a double-lumen tube (DLT)，37F for male and 35F for female patients.Tube position was confirmed by bronchoscopy in the supine and lateral positions.Anesthesia was maintained with sevoflurane 1.0-1.5 vol%，propofol 2-4 mg/(kg·h) and remifentanil 0.1-0.2 μg/(kg·min) and intermittent cisatracurium 0.06-0.1 mg/kg.The lungs were initially ventilated using a volume-controlled ventilation mode,two-lung ventilation(TLV):tidal volume (VT) 8 ml/kg,respiratory rate 12-14 bpm, inspiratory:expiratory (I:E) ratio 1:2, in 60% oxygen without PEEP. During OLV, VT was reduced to 6 ml/kg,OLV was initiated at the moment of skin incision.Both groups received an alveolar recruitment maneuver(increase inspiratory pressure to 30cmH2O for 10s) at the 10min after one-lung ventilation. After the alveolar recruitment maneuver,the study group titrate PEEP from 4cmH2O,increased in 2cmH2O steps and hold at each step for 1min,and the static pulmonary compliance(Cst) would be record.Optimal PEEP was determined until the maximal static pulmonary compliance was obtained.In the control group at PEEP level of 5 cmH2O was established and maintained during the study period.Blood gas analyses, respiratory variables, and hemodynamic variables were recorded at 6 different time points:10 min after TLV(T0), 10min after OLV(T1), 30min after PEEP(T2), 60min after PEEP(T3), 10min after the end OLV(T4) and 20min after extubation(T5).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| optimal PEEP group | Experimental | Device: compliance guided an optimal Positive End-Expiratory PressureThe study group titrate PEEP from 4cmH2O,increased in 2cmH2O steps and hold at each step for 1min,and the static pulmonary compliance(Cst) would be record.Optimal PEEP was determined until the maximal static pulmonary compliance was obtained |
| PEEP level of 5 cmH2O group | Active comparator | Device: PEEP level of 5 cmH2OIn the control group at PEEP level of 5 cmH2O was established and maintained during the study period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 yr to 65 yr
- Body mass index(BMI)18-28kg/m2
- American Society of Anesthesiologists Physical Status Classifications I to II
- Normal cardiac and pulmonary function
- Diagnosed with uncomplicated lung cancer and was to receive video-assist thoracoscopic lobectomy under general anesthesia.
Key exclusion criteria (12 listed)
- Forced expiratory volume at one second/forced vital capacity <70%
- Asthma
- Chronic obstructive pulmonary disease
- Acute lung infection
- Past history of thoracic surgery
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 |
|---|---|---|
| compliance guided an optimal Positive End-Expiratory PressureThe study groups received an alveolar recruitment maneuver(increase inspiratory pressure to 30cmH2O for 10s) at the 10min after one-lung ventilation. After the alveolar recruitment maneuver,the study group titrate PEEP from 4cmH2O,increased in 2cmH2O steps and hold at each step for 1min,and the static pulmonary compliance(Cst) would be record.Optimal PEEP was determined until the maximal static pulmonary compliance was obtained. | Device | optimal PEEP group |
| PEEP level of 5 cmH2OIn the control group at PEEP level of 5 cmH2O was established and maintained during the study period | Device | PEEP level of 5 cmH2O group |
Primary outcome
arterial oxygenation
Time frame: 24 hours
To observe the effect of compliance guided an optimal Positive End-Expiratory Pressure（PEEP）on arterial oxygenation
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 15 Jan 2019.
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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.
Wenhua chen principal investigator
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing compliance guided an optimal Positive End-Expiratory Pressure and PEEP level of 5 cmH2O in people with Lung Cancer, run by Fujian Medical University Union Hospital at 1 site in China.
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 5 inclusion and 12 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 15 Jan 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 China. 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?
arterial oxygenation (time frame: 24 hours). 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 15 Jan 2019.