- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03061617
Comparison of Different Ventilation Mode During One-lung Ventilation
Comparison of Pressure-controlled Ventilation With Volume-controlled Ventilation During One-lung Ventilation
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a single center, single blinded prospective study on two different ventilation mode during one lung ventilation for patients under video assistant thoracoscopy(VATS) lobectomy. After institutional approval and written informed consent were obtained, 60 patients with primary lung cancer under VATS lobectomy in Zhongshan Hospital Fudan University were enrolled and randomized into two groups:VCV group(group V) or PCV group(group P).
Inclusion criteria were age between 18-75 years , ASA I-II, lateral decubitus position with at least 1h OLV and preoperative FEV1>50% predicted. Preoperative exclusion criteria were previous lobectomy , COPD , asthma, uncompensated cardiac disease or contraindications for epidural catheter. Intraoperative exclusion criteria were SpO2 under 90% after intratracheal suction, reconfirmation the position of double lumen tracheal tube(DLT) and recruitment maneuver of dependant lungs.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China, 200032
- Zhongshan hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA I-II, lateral decubitus position with at least 1h OLV and preoperative FEV1>50% predicted
Exclusion Criteria:
- Preoperative exclusion criteria were previous lobectomy , COPD , asthma, uncompensated cardiac disease or contraindications for epidural catheter. Intraoperative exclusion criteria were SpO2 under 90% after intratracheal suction, reconfirmation the position of double lumen tracheal tube(DLT) and recruitment maneuver of dependant lungs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: volume controlled ventilation (VCV)
VCV mode, tide volume 6ml/kg, f 12-14, set fixed tide volume for each breath
|
set fixed 6ml/kg tide volume
|
Experimental: pressure controlled ventilation (PCV)
PCV mode, pressure is adjusted to achieve tide volume 6ml/kg, f 12-14
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adjust pressure to achieve tide volume of 6ml/kg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Airway pressure Ppeak
Time Frame: during procedure
|
Airway pressure Ppeak in cmH2O.
|
during procedure
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Airway pressure Pplat
Time Frame: during procedure
|
Airway pressure Pplat in cmH2O.
|
during procedure
|
oxygenation index
Time Frame: during procedure
|
Oxygenation index is calculated by PaO2/FiO2.
PaO2 is measured by blood-gas analysis in mmHg.
FiO2 is measured by gas monitor.
|
during procedure
|
oxygenation index
Time Frame: surgery
|
Oxygenation index is calculated by PaO2/FiO2.
PaO2 is measured by blood-gas analysis in mmHg.
FiO2 is calculated by [21+4×oxygen flow(L/min)]×100%.
|
surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative complications
Time Frame: within 30 days after surgery
|
including air leak, pneumonia, bronchopleural fistula, respiratory failure, ARDS, reintubation, tracheostomy, pulmonary embolism, arrhythmia requiring treatment, myocardial infarction, renal dysfunction, central neurologic event, sepsis, unexpected return to operating room, unexpected ICU admission and mortality within 30 days
|
within 30 days after surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Song SY, Jung JY, Cho MS, Kim JH, Ryu TH, Kim BI. Volume-controlled versus pressure-controlled ventilation-volume guaranteed mode during one-lung ventilation. Korean J Anesthesiol. 2014 Oct;67(4):258-63. doi: 10.4097/kjae.2014.67.4.258. Epub 2014 Oct 27.
- Lin F, Pan L, Qian W, Ge W, Dai H, Liang Y. Comparison of three ventilatory modes during one-lung ventilation in elderly patients. Int J Clin Exp Med. 2015 Jun 15;8(6):9955-60. eCollection 2015.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2012-064
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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