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

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 laparo...

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Autores principales:	Danfeng Jin, Mingyue Liu, Jian Huang, Yongfeng Xu, Luping Liu, Changhong Miao, Jing Zhong
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Gas embolism Laparoscopic liver resection (LLR) Pneumoperitoneum pressure (PP) Inferior vena cava-collapsibility index (IVC-CI) Randomized controlled trial Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/3269864dfc22496c8de2edacd01b121e
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spelling	oai:doaj.org-article:3269864dfc22496c8de2edacd01b121e2021-11-21T12:31:12ZGas embolism under standard versus low pneumoperitoneum pressure during laparoscopic liver resection (GASES): study protocol for a randomized controlled trial10.1186/s13063-021-05678-81745-6215https://doaj.org/article/3269864dfc22496c8de2edacd01b121e2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05678-8https://doaj.org/toc/1745-6215Abstract 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.Danfeng JinMingyue LiuJian HuangYongfeng XuLuping LiuChanghong MiaoJing ZhongBMCarticleGas embolismLaparoscopic liver resection (LLR)Pneumoperitoneum pressure (PP)Inferior vena cava-collapsibility index (IVC-CI)Randomized controlled trialMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Gas embolism Laparoscopic liver resection (LLR) Pneumoperitoneum pressure (PP) Inferior vena cava-collapsibility index (IVC-CI) Randomized controlled trial Medicine (General) R5-920
spellingShingle	Gas embolism Laparoscopic liver resection (LLR) Pneumoperitoneum pressure (PP) Inferior vena cava-collapsibility index (IVC-CI) Randomized controlled trial Medicine (General) R5-920 Danfeng Jin Mingyue Liu Jian Huang Yongfeng Xu Luping Liu Changhong Miao Jing Zhong Gas embolism under standard versus low pneumoperitoneum pressure during laparoscopic liver resection (GASES): study protocol for a randomized controlled trial
description	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.
format	article
author	Danfeng Jin Mingyue Liu Jian Huang Yongfeng Xu Luping Liu Changhong Miao Jing Zhong
author_facet	Danfeng Jin Mingyue Liu Jian Huang Yongfeng Xu Luping Liu Changhong Miao Jing Zhong
author_sort	Danfeng Jin
title	Gas embolism under standard versus low pneumoperitoneum pressure during laparoscopic liver resection (GASES): study protocol for a randomized controlled trial
title_short	Gas embolism under standard versus low pneumoperitoneum pressure during laparoscopic liver resection (GASES): study protocol for a randomized controlled trial
title_full	Gas embolism under standard versus low pneumoperitoneum pressure during laparoscopic liver resection (GASES): study protocol for a randomized controlled trial
title_fullStr	Gas embolism under standard versus low pneumoperitoneum pressure during laparoscopic liver resection (GASES): study protocol for a randomized controlled trial
title_full_unstemmed	Gas embolism under standard versus low pneumoperitoneum pressure during laparoscopic liver resection (GASES): study protocol for a randomized controlled trial
title_sort	gas embolism under standard versus low pneumoperitoneum pressure during laparoscopic liver resection (gases): study protocol for a randomized controlled trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/3269864dfc22496c8de2edacd01b121e
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Gas embolism under standard versus low pneumoperitoneum pressure during laparoscopic liver resection (GASES): study protocol for a randomized controlled trial

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