Comparison of Different Ventilation Mode During One-lung Ventilation

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03061617
Collaborator
(none)
64
1
2
5
12.7

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: VCV mode
  • Other: PCV mode
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Comparison of Pressure-controlled Ventilation With Volume-controlled Ventilation During One-lung Ventilation
Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: volume controlled ventilation (VCV)

VCV mode, tide volume 6ml/kg, f 12-14, set fixed tide volume for each breath

Other: VCV mode
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

Other: PCV mode
adjust pressure to achieve tide volume of 6ml/kg

Outcome Measures

Primary Outcome Measures

  1. Airway pressure Ppeak [during procedure]

    Airway pressure Ppeak in cmH2O.

  2. Airway pressure Pplat [during procedure]

    Airway pressure Pplat in cmH2O.

  3. oxygenation index [during procedure]

    Oxygenation index is calculated by PaO2/FiO2. PaO2 is measured by blood-gas analysis in mmHg. FiO2 is measured by gas monitor.

  4. oxygenation index [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%.

Secondary Outcome Measures

  1. postoperative complications [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongshan Hospital Shanghai Shanghai China 200032

Sponsors and Collaborators

  • Shanghai Zhongshan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
JingCang, Professor, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT03061617
Other Study ID Numbers:
  • B2012-064
First Posted:
Feb 23, 2017
Last Update Posted:
Feb 23, 2017
Last Verified:
Feb 1, 2017
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2017