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Ventilator LungNCT05490147

Effect of Low Tidal Ventilation on Intraoperative Bleeding in Laparoscopic Major Hepatectomy

A study testing conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group and low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume in people with Ventilator Lung and Liver Cirrhosis, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This randomized controlled study's objective is to find a safer mechanical ventilation strategy to reduce intraoperative bleeding in liver cancer patients undergoing laparoscopic major liver resection. The hypothesis is that low tidal volume ventilation in laparoscopic major hepatectomy results in less bleeding. Read more about this study

Who is it for?
Ages 19 to 80 years
What is being tested?
conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group and low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteSouth Korea
Study dates
8 Aug 2022to 8 Aug 2023
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 19 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with hepatocellular carcinoma scheduled for laparoscopic major hepatectomy, defined as resection of more than 30% of non-anatomical resection or more than 3 segments

Who cannot join

  • ASA class >4
  • patients with chronic obstructive pulmonary disease
  • patients with Child-Pugh score C
  • patients with arrythmia

Trial locations and contacts

1 site in 1 country.

Seong Mi Yang contact

+82-10-7300-6282

seongmi.yang@gmail.com

Hye-Yeon Cho contact

bdbd7799@gmail.com

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: Effect of Low Tidal Volume Ventilation Strategy Combined Goal -Directed Fluid Therapy on Intraoperative Bleeding Undergoing Laparoscopic Major Hepatectomy in Liver Cancer Patients: a Surgeon Blinded Randomized Controlled Study

This randomized controlled study's objective is to find a safer mechanical ventilation strategy to reduce intraoperative bleeding in liver cancer patients undergoing laparoscopic major liver resection. The hypothesis is that low tidal volume ventilation in laparoscopic major hepatectomy results in less bleeding.

Read the detailed description

Patients are randomized into the conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group and low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume group and ventilated accordingly throughout the surgery. All patients undergo general anesthesia with propofol, remifentanil, and rocuronium and are intubated with an endotracheal tube (ID 7.0 for females, ID 7.5 for males). Anesthesia is maintained with sevoflurane, end tidal CO2 is targeted between 30-35mmHg. The radial artery is cannulated and connected to the Flotrac sensor and goal directed fluid therapy is done. The estimated blood loss is checked as the primary outcome. In addition postoperative complications, transfusion amounts, operation time, satisfaction of the surgeon and participants are also recorded.

Being tested
conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group, low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume
Medical subject headings
Liver Cirrhosis, Carcinoma, Hepatocellular, Blood Loss, Surgical

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) groupProcedure or surgery

    In the conventional tidal volume group, patients are ventilated with a tidal volume [ml]= ideal body weight [kg]* 10~12.

  • low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volumeProcedure or surgery

    In the low tidal volume group, patients are ventilated with a tidal volume [ml]= ideal body weight [kg]* 6~8.

Study groups in NCT05490147
Study groupRoleWhat they receive
conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) groupExperimentalIn the conventional tidal volume group, patients are ventilated with a tidal volume [ml]= ideal body weight [kg]* 10~12 throughout the surgery.
Receives: Procedure: conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group
low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volumeExperimentalIn the low tidal volume group, patients are ventilated with a tidal volume [ml]= ideal body weight [kg]* 6~8 throughout the surgery.
Receives: Procedure: low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intraoperative blood loss

    amount drained from peritoneal cavity - irrigation fluid

    Measured: during surgery

Secondary outcomes (11)

  1. postoperative lung complications

    atelectasis, pneumonia

    Measured: op end ~ postoperative 2 weeks

  2. transfusion amount

    RBC, FFP, platelet

    Measured: op. end ~ postoperative day 3

  3. postoperative hemoglobin level

    postoperative hemoglobin

    Measured: op. end ~ postoperative day 3

  4. postoperative total bilirubin level

    postoperative total bilirubin level

    Measured: op. end ~ postoperative day 3

  5. postoperative PT INR level

    postoperative PT INR level

    Measured: op. end ~ postoperative day 3

  6. postoperative aspartate aminotransferase level

    postoperative aspartate aminotransferase level

    Measured: op. end ~ postoperative day 3

  7. postoperative alanine aminotransferase level

    postoperative alanine aminotransferase level

    Measured: op. end ~ postoperative day 3

  8. postoperative serum creatinine level

    postoperative serum creatinine level

    Measured: op. end ~ postoperative day 3

  9. operation time

    operation time

    Measured: during surgery

  10. amount of crystalloids infused

    amount of crystalloids infused

    Measured: during surgery

  11. Satisfaction scale of the operator and participants

    easy 0 - 10 difficult

    Measured: during surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2022
  2. Study start8 Aug 2022 (estimated)
  3. Primary completion8 Aug 2023 (estimated)
  4. Study completion8 Aug 2023 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
a surgeon blinded randomized controlled study
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05490147
Sponsor's protocol ID
2206-069-1332
Status last verified
Jul 2022
First submitted
31 Jul 2022
Last updated
5 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hendi M, Lv J, Cai XJ. Current status of laparoscopic hepatectomy for the treatment of hepatocellular carcinoma: A systematic literature review. Medicine (Baltimore). 2021 Dec 17;100(50):e27826. doi: 10.1097/MD.0000000000027826.

    PubMed 34918631

  • Nomi T, Fuks D, Govindasamy M, Mal F, Nakajima Y, Gayet B. Risk factors for complications after laparoscopic major hepatectomy. Br J Surg. 2015 Feb;102(3):254-60. doi: 10.1002/bjs.9726. Epub 2014 Dec 17.

    PubMed 25522176

  • Jones RM, Moulton CE, Hardy KJ. Central venous pressure and its effect on blood loss during liver resection. Br J Surg. 1998 Aug;85(8):1058-60. doi: 10.1046/j.1365-2168.1998.00795.x.

    PubMed 9717995

  • Kobayashi S, Honda G, Kurata M, Tadano S, Sakamoto K, Okuda Y, Abe K. An Experimental Study on the Relationship Among Airway Pressure, Pneumoperitoneum Pressure, and Central Venous Pressure in Pure Laparoscopic Hepatectomy. Ann Surg. 2016 Jun;263(6):1159-63. doi: 10.1097/SLA.0000000000001482.

    PubMed 26595124

  • Gao X, Xiong Y, Huang J, Zhang N, Li J, Zheng S, Lu K, Ma D, Yang B, Ning J. The Effect of Mechanical Ventilation With Low Tidal Volume on Blood Loss During Laparoscopic Liver Resection: A Randomized Controlled Trial. Anesth Analg. 2021 Apr 1;132(4):1033-1041. doi: 10.1213/ANE.0000000000005242.

    PubMed 33060490

  • Katz SC, Shia J, Liau KH, Gonen M, Ruo L, Jarnagin WR, Fong Y, D'Angelica MI, Blumgart LH, Dematteo RP. Operative blood loss independently predicts recurrence and survival after resection of hepatocellular carcinoma. Ann Surg. 2009 Apr;249(4):617-23. doi: 10.1097/SLA.0b013e31819ed22f.

    PubMed 19300227

  • Dunki-Jacobs EM, Philips P, Scoggins CR, McMasters KM, Martin RC 2nd. Stroke volume variation in hepatic resection: a replacement for standard central venous pressure monitoring. Ann Surg Oncol. 2014 Feb;21(2):473-8. doi: 10.1245/s10434-013-3323-9. Epub 2013 Oct 23.

    PubMed 24150192

  • Correa-Gallego C, Tan KS, Arslan-Carlon V, Gonen M, Denis SC, Langdon-Embry L, Grant F, Kingham TP, DeMatteo RP, Allen PJ, D'Angelica MI, Jarnagin WR, Fischer M. Goal-Directed Fluid Therapy Using Stroke Volume Variation for Resuscitation after Low Central Venous Pressure-Assisted Liver Resection: A Randomized Clinical Trial. J Am Coll Surg. 2015 Aug;221(2):591-601. doi: 10.1016/j.jamcollsurg.2015.03.050. Epub 2015 Apr 7.

    PubMed 26206652

  • Ratti F, Cipriani F, Reineke R, Catena M, Paganelli M, Comotti L, Beretta L, Aldrighetti L. Intraoperative monitoring of stroke volume variation versus central venous pressure in laparoscopic liver surgery: a randomized prospective comparative trial. HPB (Oxford). 2016 Feb;18(2):136-144. doi: 10.1016/j.hpb.2015.09.005. Epub 2015 Nov 17.

    PubMed 26902132

  • Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.

    PubMed 23902482

  • Serpa Neto A, Schultz MJ, Gama de Abreu M. Intraoperative ventilation strategies to prevent postoperative pulmonary complications: Systematic review, meta-analysis, and trial sequential analysis. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):331-40. doi: 10.1016/j.bpa.2015.09.002. Epub 2015 Sep 18.

    PubMed 26643098

Questions about this trial

What is this clinical trial studying?

A study testing conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group and low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume in people with Ventilator Lung and Liver Cirrhosis, run by Seoul National University Hospital at 1 site in South Korea.

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 1 inclusion and 4 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 5 Aug 2022. 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 South Korea. 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 Seong Mi Yang (+82-10-7300-6282, seongmi.yang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraoperative blood loss (time frame: during surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05490147, which also lists 11 linked publications.

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 5 Aug 2022.

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