NDLI: Gas embolism under standard versus low pneumoperitoneum pressure during laparoscopic liver resection (GASES): study protocol for a randomized controlled trial

Content Provider	Springer Nature : BioMed Central
Author	Jin, Danfeng Liu, Mingyue Huang, Jian Xu, Yongfeng Liu, Luping Miao, Changhong Zhong, Jing
Abstract	Background Gas embolism induced by CO2 pneumoperitoneum is commonly identified as a risk factor for morbidity, especially cardiopulmonary morbidity, after laparoscopic liver resection (LLR) in adults. Increasing pneumoperitoneum pressure (PP) contributes to gas accumulation following laparoscopy. However, few studies have examined the effects of PP in the context of LLR. In LLR, the PP-central venous pressure (CVP) gradient is increased due to hepatic vein rupture, hepatic sinusoid exposure, and low CVP management, which together increase the risk of CO2 embolization. The aim of this study is to primarily determine the role of low PP (10 mmHg) on the incidence of severe gas embolism. Methods Adult participants (n = 140) undergoing elective LLR will be allocated to either a standard (15 mmHg) or low (10 mmHg) PP group. Anesthesia management, postoperative care, and other processes will be performed similarly in both groups. The occurrence of severe gas embolism, which is defined as gas embolism ≥ grade 3 according to the Schmandra microbubble method, will be detected by transesophageal echocardiography (TEE) and recorded as the primary outcome. The subjects will be followed up until discharge and followed up by telephone 1 and 3 months after surgery. Postoperative outcomes, such as the Post-Operative Quality of Recovery Scale, pain severity, and adverse events, will be assessed. Serum cardiac markers and inflammatory factors will also be assessed during the study period. The correlation between intraoperative inferior vena cava-collapsibility index (IVC-CI) under TEE and central venous pressure (CVP) will also be explored. Discussion This study is the first prospective randomized clinical trial to determine the effect of low versus standard PP on gas embolism using TEE during elective LLR. These findings will provide scientific and clinical evidence of the role of PP. Trial status Protocol version: version 1 of 21-08-2020 Trial registration ChiCTR2000036396 ( http://www.chictr.org.cn ). Registered on 22 August 2020.
Related Links	https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-021-05678-8.pdf
Ending Page	12
Page Count	12
Starting Page	1
File Format	HTM / HTML
ISSN	17456215
DOI	10.1186/s13063-021-05678-8
Journal	Trials
Issue Number	1
Volume Number	22
Language	English
Publisher	BioMed Central
Publisher Date	2021-11-15
Access Restriction	Open
Subject Keyword	Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Gas embolism Laparoscopic liver resection (LLR) Pneumoperitoneum pressure (PP) Inferior vena cava-collapsibility index (IVC-CI) Randomized controlled trial Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Medicine Pharmacology (medical)
Journal Impact Factor	2/2023
5-Year Journal Impact Factor	2.1/2023

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