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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02198625

Enrollment

280

Registered

2014-07-23

Start date

2014-03-31

Completion date

2015-06-30

Last updated

2014-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatectomy

Keywords

Moderate FiO2, Protective lung ventilation, Postoperative pulmonary complications, Positive end-expiratory pressure, recruitment maneuvers

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.

Interventions

OTHERModerate FiO2 and Protective Lung Ventilation Using

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame	Description
a composite of pulmonary and extrapulmonary complications occurring by day 7 after surgery.	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

Measure	Time frame	Description
incidence of pulmonary complications	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;
Oxidative stress markers	2 days	Oxidative stress markers variation in blood before anesthesia,during and after surgery , and compare with controls.

Countries

China

Contacts

Primary ContactFenmei Shi, M.M.

shifenmei2006@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026