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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Device: compliance guided an optimal Positive End-Expiratory Pressure; Device: PEEP level of 5 cmH2O

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • FujianUnionHospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; In the control group at PEEP level of 5 cmH2O was established and maintained during the study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
arterial oxygenation	To observe the effect of compliance guided an optimal Positive End-Expiratory Pressure（PEEP）on arterial oxygenation	24 hours

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital
• Investigators: Principal Investigator: Wenhua chen, Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 14, 2018
• Primary Completion (ACTUAL): October 11, 2018
• Study Completion (ACTUAL): November 1, 2018

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: January 13, 2019
• First Posted (ACTUAL): January 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 13, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: FujianUnionAnethesiaOne

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No