Blood LossNCT03399123
Effect of Low Tidal Volume on Blood Loss During Laparoscopic Hepatectomy
A study testing Tidal volume in people with Blood Loss, run by Southwest Hospital, China at 1 site in China.
Trial summary
To explore the effect of low tidal volume on blood loss and gas exchange during laparoscopic hepatectomy Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Blood Loss
- What is being tested?
- Tidal volume
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 30 Oct 2018
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 18 to 70 years old;
- American association of anesthesiologists(ASA) score I to III;
- Ability to adhere to the study schedule;
- Ability to provide informed consent and complete all study assessments;
- Patients undergoing selective surgery of laparoscopic hepatectomy.
Who cannot join
- The New York Heart Association classification(NYHA) III to IV;
- Chronic obstructive pulmonary disease,respiratory failure, patients after thoracic surgery.
- BMI>32Kg/m2;
- Abnormal in blood coagulation function;
- Patients with mental disease;
- Patients with neuromuscular disease;
- Concurrent enrollment in another Randomized controlled trial(RCT);
- Absence of written informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Ning Jiaolin, 0086-15808014085, Njiaolin1976@126.com
About this study
To explore the effect of low tidal volume on blood loss and gas exchange during laparoscopic hepatectomy
Read the detailed description
Background \& Aims:Liver cancer is an disease that threatening human health .Laparoscopic hepatectomy is more and more widely used.It is very important to reduce the bleeding during laparoscopic hepatectomy.The investigators found that low tidal volume can effectively reduce intraoperative bleeding.The aim of this study was to explore the effect of low tidal volume on blood loss and gas exchange during laparoscopic hepatectomy
- Conditions
- Blood Loss
- Being tested
- Tidal volume
- Keywords
- Laparoscopic hepatectomy, Low tidal volume, Blood loss
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tidal volumeOther
After General anesthesia, patients that during volume control mode of mechanical ventilation in experimental group, we take low tidal volume.
| Study group | Role | What they receive |
|---|---|---|
| Low tidal volume group | Experimental | Use a low tidal volume(6'8ml/kg) ventilation mode during liver segmentation。 Receives: Other: Tidal volume |
| Standard tidal volume group | Active comparator | Use a standard tidal volume(10'12ml/kg) ventilation mode during operation. Receives: Other: Tidal volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
Blood loss during operation.
Measured: through study completion, an average of 48hours
Secondary outcomes (3)
central venous pressure
The central venous pressure(CVP)during operation
Measured: During operation
mean arterial pressure
The mean arterial pressure(MAP)during operation
Measured: During operation
oxygenation index
The oxygenation index during operation.
Measured: During operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start1 Apr 2017
- Primary completion30 Oct 2018 (estimated)
- Study completion30 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood LossStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two different tidal volume are conducted on the participant base on the randomized choices
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuguo Zheng, MD, Southwest Hospital, China
- Investigators
- Zheng ShuGuo, Principal investigator, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399123
- Sponsor's protocol ID
- MZK001
- Status last verified
- Jan 2018
- First submitted
- 4 Jan 2018
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Tidal Volume on Blood Loss During Laparoscopic Hepatectomy
- ClinicalTrials.gov ID
- NCT03399123
- Acronym / sponsor ID
- MZK001
- Conditions
- Blood Loss
- Keywords
- Laparoscopic hepatectomy, Low tidal volume, Blood loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Oct 2018 (estimated)
- Study completion
- 30 Oct 2018 (estimated)
- First posted
- 16 Jan 2018 (actual)
- 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.
To explore the effect of low tidal volume on blood loss and gas exchange during laparoscopic hepatectomy
Detailed description
Background \& Aims:Liver cancer is an disease that threatening human health .Laparoscopic hepatectomy is more and more widely used.It is very important to reduce the bleeding during laparoscopic hepatectomy.The investigators found that low tidal volume can effectively reduce intraoperative bleeding.The aim of this study was to explore the effect of low tidal volume on blood loss and gas exchange during laparoscopic hepatectomy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Two different tidal volume are conducted on the participant base on the randomized choices
| Arm | Type | Receives |
|---|---|---|
| Low tidal volume group | Experimental | Other: Tidal volumeUse a low tidal volume(6'8ml/kg) ventilation mode during liver segmentation。 |
| Standard tidal volume group | Active comparator | Other: Tidal volumeUse a standard tidal volume(10'12ml/kg) ventilation mode during operation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged from 18 to 70 years old;
- American association of anesthesiologists(ASA) score I to III;
- Ability to adhere to the study schedule;
- Ability to provide informed consent and complete all study assessments;
- Patients undergoing selective surgery of laparoscopic hepatectomy.
Key exclusion criteria (8 listed)
- The New York Heart Association classification(NYHA) III to IV;
- Chronic obstructive pulmonary disease,respiratory failure, patients after thoracic surgery.
- BMI>32Kg/m2;
- Abnormal in blood coagulation function;
- Patients with mental disease;
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 |
|---|---|---|
| Tidal volumeAfter General anesthesia, patients that during volume control mode of mechanical ventilation in experimental group, we take low tidal volume. | Other | Low tidal volume group, Standard tidal volume group |
Primary outcome
Blood loss
Time frame: through study completion, an average of 48hours
Blood loss during operation.
3 secondary outcomes
central venous pressure
Time frame: During operation
mean arterial pressure
Time frame: During operation
oxygenation index
Time frame: During operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
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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.
Zheng ShuGuo principal investigator
MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tidal volume in people with Blood Loss, run by Southwest Hospital, China 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 8 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 16 Jan 2018. 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.
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 Ning Jiaolin (0086-15808014085, Njiaolin1976@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss (time frame: through study completion, an average of 48hours). 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 16 Jan 2018.