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

NCT03804398 | Completed

• 1 other identifier: FujianUnionAnethesiaOne
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• arterial oxygenation

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

  24 hours

Study Arms (2)

optimal PEEP group

EXPERIMENTAL

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

PEEP level of 5 cmH2O group

ACTIVE COMPARATOR

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

compliance guided an optimal Positive End-Expiratory Pressure DEVICE

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.

optimal PEEP group

PEEP level of 5 cmH2O DEVICE

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

PEEP level of 5 cmH2O group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

FujianUnionHospital

Fuzhou, Fujian, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wenhua chen

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 15, 2019
• Study Start: June 14, 2018
• Primary Completion: October 11, 2018
• Study Completion: November 1, 2018
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

CN (1)