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Influence of Moderate Inspired Oxygen Fraction (FiO2) and Protective Ventilation on Postoperative Pulmonary Complication

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ClinicalTrials.gov Identifier: NCT02198625
Recruitment Status : Unknown
Verified July 2014 by Fenmei Shi, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : July 23, 2014
Last Update Posted : July 23, 2014
Sponsor:
Information provided by (Responsible Party):
Fenmei Shi, First Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
The purpose of this study is to determine the influence of moderate FiO2 and the lung protective ventilation on postoperative pulmonary complications following hepatic resection surgery.

Condition or disease Intervention/treatment Phase
Hepatectomy Other: Moderate FiO2 and Protective Lung Ventilation Using Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Arm Intervention/treatment
No Intervention: FiO2 80%,Nonprotective Lung Ventilation
Experimental: FiO2 30%,Nonprotective Lung Ventilation
FiO2 30%,Nonprotective Lung Ventilation
Other: Moderate FiO2 and Protective Lung Ventilation Using
Experimental: FiO2 80%,protective Lung Ventilation
FiO2 80% and protective Lung Ventilation
Other: Moderate FiO2 and Protective Lung Ventilation Using
Experimental: FiO2 30%,protective Lung Ventilation
FiO2 30% and protective Lung Ventilation
Other: Moderate FiO2 and Protective Lung Ventilation Using



Primary Outcome Measures :
  1. a composite of pulmonary and extrapulmonary complications occurring by day 7 after surgery. [ Time Frame: during the first seven days after surgery ]
    The primary outcome was a composite of major pulmonary complications (defined as pneumonia or need for invasive or noninvasive ventilation for acute respiratory failure) and extrapulmonary complications (defined as sepsis, septic shock, or death) within the first 7 days after surgery.


Secondary Outcome Measures :
  1. incidence of pulmonary complications [ Time Frame: within the 30-day follow-up period ]
    the incidence of pulmonary complications due to any cause, graded on a scale from 0 (no pulmonary complications) to 4 (the most severe complications);extrapulmonary complications; durations of ICU and hospital stays;

  2. Oxidative stress markers [ Time Frame: 2 days ]
    Oxidative stress markers variation in blood before anesthesia,during and after surgery , and compare with controls.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA 1~2,Planned intrabdominal hepatic resection surgery;
  • Expected duration 2 hours to 6 hours;
  • Age 40 yr to 70 yr);
  • BMI 18-26.9kg/m2
  • Risk of postoperative pulmonary complications (Arozullah score ≥2);

Exclusion Criteria:

  • Noninvasive ventilation in the last 30 days;
  • Recent history of pneumonia, ALI/ARDS (in the last 30 days);
  • History of pulmonary resection;
  • History of neuromuscular disease;
  • Child-Pugh>A grade;
  • Patient refusal;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198625


Contacts
Contact: Fenmei Shi, M.M. shifenmei2006@163.com

Locations
China, Guangdong
First Affiliated Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China
Contact: Ying Xiao, MD,PhD       xying2603@163.com   
Principal Investigator: Ying Xiao, MD,PhD         
Sponsors and Collaborators
Fenmei Shi

Responsible Party: Fenmei Shi, resident, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02198625     History of Changes
Other Study ID Numbers: 18826410080
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: July 2014

Keywords provided by Fenmei Shi, First Affiliated Hospital, Sun Yat-Sen University:
Moderate FiO2
Protective lung ventilation
Postoperative pulmonary complications
Positive end-expiratory pressure
recruitment maneuvers