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Comparison of Different Ventilation Mode During One-lung Ventilation

Comparison of Pressure-controlled Ventilation With Volume-controlled Ventilation During One-lung Ventilation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03061617
Enrollment
64
Registered
2017-02-23
Start date
2016-07-31
Completion date
2016-12-31
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

One Lung Ventilation, Thoracic Surgery, Ventilator-Induced Lung Injury

Brief summary

It is controversial as to which ventilation mode is better in one-lung ventilation(OLV), volume controlled ventilation(VCV) or pressure controlled ventilation(PCV). This study was designed to figure out if there was any difference between these two modes on oxygenation and postoperative complications under the condition of protective ventilation(PV).

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.

Interventions

OTHERVCV mode

set fixed 6ml/kg tide volume

OTHERPCV mode

adjust pressure to achieve tide volume of 6ml/kg

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* ASA I-II, lateral decubitus position with at least 1h OLV and preoperative FEV1\>50% predicted

Exclusion criteria

* Preoperative

Design outcomes

Primary

MeasureTime frameDescription
Airway pressure Ppeakduring procedureAirway pressure Ppeak in cmH2O.
Airway pressure Pplatduring procedureAirway pressure Pplat in cmH2O.
oxygenation indexduring procedureOxygenation index is calculated by PaO2/FiO2. PaO2 is measured by blood-gas analysis in mmHg. FiO2 is measured by gas monitor.

Secondary

MeasureTime frameDescription
postoperative complicationswithin 30 days after surgeryincluding 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026