Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04889235
Status:
UNKNOWN
Last Update Posted:
2021-05-17
First Post:
2020-10-21
Brief Title:
Diaphragm Kinetics Following Hepatic Resection
Sponsor:
RWTH Aachen University
Organization:
RWTH Aachen University
Study Overview
Official Title:
Diaphragm Kinetics Following Hepatic Resection Comparison Between a Sarcopenic and Non-sarcopenic Cohort
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sarcopenia is associated with reduced pulmonary function in healthy adults as well as with increased risk of pneumonia following abdominal surgery Consequentially postoperative pneumonia prolongs hospital admission and increases in-hospital mortality following a range of surgical interventions Little is known about the function of the diaphragm in the context of sarcopenia and wasting disorders or how its function is influenced by abdominal surgery Liver surgery induces reactive pleural effusion in most patients compromising post-operative pulmonary function
Hypotheses
Both major hepatic resection and sarcopenia have a measurable impact on diaphragm function
Sarcopenia is associated with reduced preoperative diaphragm function and that patients with reduced preoperative diaphragm function show a greater decline and reduced recovery of diaphragm function following major hepatic resection
Goals
The primary goal of this study is to evaluate whether sarcopenic patients have a reduced diaphragm function prior to major liver resection compared to non-sarcopenic patients and to evaluate whether sarcopenic patients show a greater reduction in respiratory muscle function following major liver resection when compared to non-sarcopenic patients
Methods and analysis
Trans-costal B-mode M-mode ultrasound and speckle tracking imaging will be used to assess diaphragm function perioperatively in patients undergoing major hepatic resection starting one day prior to surgery and up to thirty days after surgery In addition rectus abdominis and quadriceps femoris muscles thickness will be measured using ultrasound to measure sarcopenia and pulmonary function will be measured using a hand-held bedside spirometer Muscle mass will be determined preoperatively using CT-muscle volumetry of abdominal muscle and adipose tissue at the third lumbar vertebra level L3 Muscle function will be assessed using handgrip strength and physical condition will be measured with a short physical performance battery SPPB A rectus abdominis muscle biopsy will be taken intraoperatively to measure proteolytic and mitochondrial activity as well as inflammation and redox status Systemic inflammation and sarcopenia biomarkers will be assessed in serum acquired perioperatively
Hypotheses
Both major hepatic resection and sarcopenia have a measurable impact on diaphragm function
Sarcopenia is associated with reduced preoperative diaphragm function and that patients with reduced preoperative diaphragm function show a greater decline and reduced recovery of diaphragm function following major hepatic resection
Goals
The primary goal of this study is to evaluate whether sarcopenic patients have a reduced diaphragm function prior to major liver resection compared to non-sarcopenic patients and to evaluate whether sarcopenic patients show a greater reduction in respiratory muscle function following major liver resection when compared to non-sarcopenic patients
Methods and analysis
Trans-costal B-mode M-mode ultrasound and speckle tracking imaging will be used to assess diaphragm function perioperatively in patients undergoing major hepatic resection starting one day prior to surgery and up to thirty days after surgery In addition rectus abdominis and quadriceps femoris muscles thickness will be measured using ultrasound to measure sarcopenia and pulmonary function will be measured using a hand-held bedside spirometer Muscle mass will be determined preoperatively using CT-muscle volumetry of abdominal muscle and adipose tissue at the third lumbar vertebra level L3 Muscle function will be assessed using handgrip strength and physical condition will be measured with a short physical performance battery SPPB A rectus abdominis muscle biopsy will be taken intraoperatively to measure proteolytic and mitochondrial activity as well as inflammation and redox status Systemic inflammation and sarcopenia biomarkers will be assessed in serum acquired perioperatively
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None