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CompletedNCT03804398Updated Jan 15, 2019

Effect of Optimal Positive End-Expiratory Pressure on Oxygenation and Intrapulmonary Shunt During One-lung Ventilation

An interventional study of compliance guided an optimal Positive End-Expiratory Pressure and PEEP level of 5 cmH2O in Lung Cancer, sponsored by Fujian Medical University Union Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-01-15.

Sponsored by Fujian Medical University Union Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jun 2018, registered Jan 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Lung Cancer
03

In context

Lead sponsor

Fujian Medical University Union Hospital is the lead sponsor of 100 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    optimal PEEP group

    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: compliance guided an optimal Positive End-Expiratory Pressure

  • Active comparator
    PEEP level of 5 cmH2O group

    In the control group at PEEP level of 5 cmH2O was established and maintained during the study period

    Device: PEEP level of 5 cmH2O

Interventions

  • Devicecompliance guided an optimal Positive End-Expiratory Pressure

    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.

  • DevicePEEP level of 5 cmH2O

    In the control group at PEEP level of 5 cmH2O was established and maintained during the study period

06

What researchers measure

Primary outcomes

  1. arterial oxygenation

    To observe the effect of compliance guided an optimal Positive End-Expiratory Pressure(PEEP)on arterial oxygenation

    Time frame: 24 hours

07

Study locations

1 site
  • FujianUnionHospital
    Fuzhou, Fujian, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03804398
Lead sponsor
Fujian Medical University Union Hospital
Responsible party
Sponsor
First posted
Jan 15, 2019
Start date
Jun 14, 2018
Primary completion
Oct 11, 2018
Completion
Nov 1, 2018
Last update
Jan 15, 2019

Study contacts

Wenhua chen
principal investigator · Fujian Medical University Union Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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