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

NCT ID: NCT05490147

Last Updated: 2022-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-08

Study Completion Date

2023-08-08

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ventilator Lung Liver Cirrhosis Hepatocellular Carcinoma Blood Loss, Surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a surgeon blinded randomized controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group

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

Group Type EXPERIMENTAL

conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group

Intervention Type PROCEDURE

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) volume

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

Interventions

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conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group

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

Intervention Type PROCEDURE

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

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* ASA class \>4
* patients with chronic obstructive pulmonary disease
* patients with Child-Pugh score C
* patients with arrythmia
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seong Mi Yang

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Seong Mi Yang

Role: CONTACT

+82-10-7300-6282

Hye-Yeon Cho

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 34918631 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25522176 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9717995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26595124 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33060490 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19300227 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24150192 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26206652 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26902132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23902482 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26643098 (View on PubMed)

Other Identifiers

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2206-069-1332

Identifier Type: -

Identifier Source: org_study_id

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