HepatectomyPhase 4NCT02198625
Influence of Moderate Inspired Oxygen Fraction (FiO2) and Protective Ventilation on Postoperative Pulmonary Complication
A Phase 4 study testing Moderate FiO2 and Protective Lung Ventilation Using in people with Hepatectomy, run by Fenmei Shi at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Hepatectomy
- What is being tested?
- Moderate FiO2 and Protective Lung Ventilation Using
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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);
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Fenmei Shi, M.M. contact
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong
Ying Xiao, MD,PhD, xying2603@163.com
Ying Xiao, MD,PhD
About this study
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.
- Conditions
- Hepatectomy
- Being tested
- Moderate FiO2 and Protective Lung Ventilation Using
- Keywords
- Moderate FiO2, Protective lung ventilation, Postoperative pulmonary complications, Positive end-expiratory pressure, recruitment maneuvers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate FiO2 and Protective Lung Ventilation UsingOther
| Study group | Role | What they receive |
|---|---|---|
| FiO2 80%,Nonprotective Lung Ventilation | No intervention | Not described |
| FiO2 30%,Nonprotective Lung Ventilation | Experimental | FiO2 30%,Nonprotective Lung Ventilation Receives: Other: Moderate FiO2 and Protective Lung Ventilation Using |
| FiO2 80%,protective Lung Ventilation | Experimental | FiO2 80% and protective Lung Ventilation Receives: Other: Moderate FiO2 and Protective Lung Ventilation Using |
| FiO2 30%,protective Lung Ventilation | Experimental | FiO2 30% and protective Lung Ventilation Receives: Other: Moderate FiO2 and Protective Lung Ventilation Using |
What is being measured
The primary outcome is the main question the study is designed to answer.
a composite of pulmonary and extrapulmonary complications occurring by day 7 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.
Measured: during the first seven days after surgery
Secondary outcomes (2)
incidence of pulmonary complications
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;
Measured: within the 30-day follow-up period
Oxidative stress markers
Oxidative stress markers variation in blood before anesthesia,during and after surgery , and compare with controls.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenmei Shi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fenmei Shi, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198625
- Sponsor's protocol ID
- 18826410080
- Status last verified
- Jul 2014
- First submitted
- 13 Jul 2014
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Moderate Inspired Oxygen Fraction (FiO2) and Protective Ventilation on Postoperative Pulmonary Complication
- ClinicalTrials.gov ID
- NCT02198625
- Acronym / sponsor ID
- 18826410080
- Conditions
- Hepatectomy
- Keywords
- Moderate FiO2, Protective lung ventilation, Postoperative pulmonary complications, Positive end-expiratory pressure, recruitment maneuvers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Fenmei ShiUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 23 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FiO2 80%,Nonprotective Lung Ventilation | No intervention | – |
| FiO2 30%,Nonprotective Lung Ventilation | Experimental | Other: Moderate FiO2 and Protective Lung Ventilation UsingFiO2 30%,Nonprotective Lung Ventilation |
| FiO2 80%,protective Lung Ventilation | Experimental | Other: Moderate FiO2 and Protective Lung Ventilation UsingFiO2 80% and protective Lung Ventilation |
| FiO2 30%,protective Lung Ventilation | Experimental | Other: Moderate FiO2 and Protective Lung Ventilation UsingFiO2 30% and protective Lung Ventilation |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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);
Key exclusion criteria (6 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate FiO2 and Protective Lung Ventilation Using | Other | FiO2 30%,Nonprotective Lung Ventilation, FiO2 30%,protective Lung Ventilation, FiO2 80%,protective Lung Ventilation |
Primary outcome
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.
2 secondary outcomes
incidence of pulmonary complications
Time frame: within the 30-day follow-up period
Oxidative stress markers
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fenmei Shi, M.M. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Moderate FiO2 and Protective Lung Ventilation Using in people with Hepatectomy, run by Fenmei Shi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fenmei Shi, M.M. (shifenmei2006@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a composite of pulmonary and extrapulmonary complications occurring by day 7 after surgery. (time frame: during the first seven days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2014.