Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595537
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-01-12
Brief Title:
Gastric Ultrasound Feeding Tube Placement Confirmation Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Gastric Ultrasound Feeding Tube Placement Confirmation Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GUT
Brief Summary:
Objective
This study aims to assess the accuracy and reliability of ultrasound in determining the correct placement of gastric feeding tubes GFTs in intensive care patients
Study Design
A diagnostic study will be conducted to evaluate the efficacy of ultrasound in determining GFT placement in all ICU patients who require GFT placement Patients will undergo ultrasound by an ultrasonographer USG after receiving a new or replaced GFT The USG will assess the presence or absence of a mosaic sign after insufflation of 20 mL of air through the GFT The mosaic sign indicates proper GFT placement in the stomach
Methods
All ultrasonographic measurements will be recorded and saved in a central picture archiving and communication system PACS The images will be labeled with the deepness of the GFT 20 cm 50 cm or tracheobronchial and anonymized before being presented to an intensivist expert in USG for interpretation
Hypothesis
A 20 mL air insufflation via a GFT at the esophageal level or via a suction catheter in the tracheobronchial system will not produce a mosaic sign on ultrasound This sign will only be present if the GFT is properly positioned in the stomach
This study aims to assess the accuracy and reliability of ultrasound in determining the correct placement of gastric feeding tubes GFTs in intensive care patients
Study Design
A diagnostic study will be conducted to evaluate the efficacy of ultrasound in determining GFT placement in all ICU patients who require GFT placement Patients will undergo ultrasound by an ultrasonographer USG after receiving a new or replaced GFT The USG will assess the presence or absence of a mosaic sign after insufflation of 20 mL of air through the GFT The mosaic sign indicates proper GFT placement in the stomach
Methods
All ultrasonographic measurements will be recorded and saved in a central picture archiving and communication system PACS The images will be labeled with the deepness of the GFT 20 cm 50 cm or tracheobronchial and anonymized before being presented to an intensivist expert in USG for interpretation
Hypothesis
A 20 mL air insufflation via a GFT at the esophageal level or via a suction catheter in the tracheobronchial system will not produce a mosaic sign on ultrasound This sign will only be present if the GFT is properly positioned in the stomach
Detailed Description:
Objective To evaluate the effectiveness of ultrasound Doppler in determining the correct placement of gastric feeding tubes GFTs in intensive care patients compared to the standard of care chest X-ray CXR
Study Design A diagnostic study involving ICU patients who require GFT placement or replacement
Background Misplacement of GFTs is a common complication in ICU settings with significant potential consequences for patient safety Ultrasound Doppler has emerged as a potential alternative to CXR for confirming GFT placement due to its portability ease of use and real-time assessment
Methods
Subject Selection Subjects will be recruited from the ICU at the Leiden University Medical Center LUMC who meet the inclusion criteria tracheally intubated require GFT placement or replacement and provide informed consent
Ultrasound Procedure At the esophageal and gastric levels ultrasound will be performed using a Philips Lumify S4-1 broad band sector array transducer An antrum Doppler window will be set to visualize the mosaic sign a characteristic Doppler signal indicative of correct GFT placement
Image Acquisition and Coding During ultrasound 20 ml of air will be injected through the GFT and images will be captured These images will be anonymized and labeled with the depth at which the insufflation occurred 20 cm or 50 cm or the location of the insufflation tracheal suction catheter
Ultrasound Interpretation An intensivist expert in ultrasound will blind to the original localization of the GFT analyze the anonymized images The intensivist will classify each image as having a mosaic sign present or mosaic sign absent
Correlation with CXR The ultrasound interpretation will be compared to the gold standard of CXR to determine the sensitivity and specificity of ultrasound Doppler
Secondary Objectives
Investigate the correlation between false positive and false negative results and patient characteristics such as gender BMI positive end-expiratory pressure PEEP tidal volume and presence of abdominal gas in CXR
Assess the safety of ultrasound Doppler in terms of adverse events AEs and serious adverse events SAEs
Sample Size A sample size of 58 patients is expected to provide sufficient power to detect statistically significant differences in sensitivity and specificity between ultrasound Doppler and CXR
Ethical Considerations
Ethical Approval The study protocol has been approved by the Leiden University Medical Center Ethical Review Board LUMC-ERB
Informed Consent All participants will provide informed consent prior to undergoing ultrasound Doppler and CXR
Safety Monitoring Adverse events will be monitored and reported as per the regulations of the LUMC and the Medical Research Involving Human Subjects Act WMO
Administrative Aspects
Data Collection and Storage Patient and clinical data including anonymized ultrasound images and CXRs will be collected and stored using the Castor cloud-based clinical data management system
Monitoring The study will be monitored by internal monitors of the Leiden University Medical Center LUMC
Reporting Annual progress reports will be submitted to the accredited METC and the final study report will be submitted upon completion of the study
Expected Findings
Ultrasound Doppler is expected to demonstrate high sensitivity and specificity in determining the correct placement of GFTs in ICU patients compared to CXR
Potential correlation between false positive and false negative results with certain patient characteristics such as gender BMI and presence of abdominal gas in CXR may be identified
The safety profile of ultrasound Doppler is expected to be favorable with minimal AEs and no SAEs
Conclusion This study aims to evaluate the efficacy of ultrasound Doppler in determining the correct placement of GFTs in ICU patients The findings of this study will contribute to the development of non-invasive methods for confirming GFT placement potentially improving patient safety and reducing the need for CXRs
Study Design A diagnostic study involving ICU patients who require GFT placement or replacement
Background Misplacement of GFTs is a common complication in ICU settings with significant potential consequences for patient safety Ultrasound Doppler has emerged as a potential alternative to CXR for confirming GFT placement due to its portability ease of use and real-time assessment
Methods
Subject Selection Subjects will be recruited from the ICU at the Leiden University Medical Center LUMC who meet the inclusion criteria tracheally intubated require GFT placement or replacement and provide informed consent
Ultrasound Procedure At the esophageal and gastric levels ultrasound will be performed using a Philips Lumify S4-1 broad band sector array transducer An antrum Doppler window will be set to visualize the mosaic sign a characteristic Doppler signal indicative of correct GFT placement
Image Acquisition and Coding During ultrasound 20 ml of air will be injected through the GFT and images will be captured These images will be anonymized and labeled with the depth at which the insufflation occurred 20 cm or 50 cm or the location of the insufflation tracheal suction catheter
Ultrasound Interpretation An intensivist expert in ultrasound will blind to the original localization of the GFT analyze the anonymized images The intensivist will classify each image as having a mosaic sign present or mosaic sign absent
Correlation with CXR The ultrasound interpretation will be compared to the gold standard of CXR to determine the sensitivity and specificity of ultrasound Doppler
Secondary Objectives
Investigate the correlation between false positive and false negative results and patient characteristics such as gender BMI positive end-expiratory pressure PEEP tidal volume and presence of abdominal gas in CXR
Assess the safety of ultrasound Doppler in terms of adverse events AEs and serious adverse events SAEs
Sample Size A sample size of 58 patients is expected to provide sufficient power to detect statistically significant differences in sensitivity and specificity between ultrasound Doppler and CXR
Ethical Considerations
Ethical Approval The study protocol has been approved by the Leiden University Medical Center Ethical Review Board LUMC-ERB
Informed Consent All participants will provide informed consent prior to undergoing ultrasound Doppler and CXR
Safety Monitoring Adverse events will be monitored and reported as per the regulations of the LUMC and the Medical Research Involving Human Subjects Act WMO
Administrative Aspects
Data Collection and Storage Patient and clinical data including anonymized ultrasound images and CXRs will be collected and stored using the Castor cloud-based clinical data management system
Monitoring The study will be monitored by internal monitors of the Leiden University Medical Center LUMC
Reporting Annual progress reports will be submitted to the accredited METC and the final study report will be submitted upon completion of the study
Expected Findings
Ultrasound Doppler is expected to demonstrate high sensitivity and specificity in determining the correct placement of GFTs in ICU patients compared to CXR
Potential correlation between false positive and false negative results with certain patient characteristics such as gender BMI and presence of abdominal gas in CXR may be identified
The safety profile of ultrasound Doppler is expected to be favorable with minimal AEs and no SAEs
Conclusion This study aims to evaluate the efficacy of ultrasound Doppler in determining the correct placement of GFTs in ICU patients The findings of this study will contribute to the development of non-invasive methods for confirming GFT placement potentially improving patient safety and reducing the need for CXRs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None