PPG vs. ICG in Gastrointestinal Resections

Perfusion Clinical Trial

Official title:

Comparison Between Fluorescenceimaging With Photoplethysmography （PPG） and Indocyaningreen (ICG) for Tissue Perfusion in Gastrointestinal Resections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06222645
• Other study ID #: spbuippg001
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: January 2024
• Source: Saint Petersburg State University, Russia
• Contact: Xuan Qiu, MD
• Phone: 79643411524
• Email: st122986[@]student.spbu.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, gastrointestinal anastomoses are examined with imaging Photoplethysmography and after this the investigators use the Standard Routine ICG-Imaging. At the end, both methods will be compared.

Description:

All gastrointestinal anastomoses were examined in all patients with written informed consent. As Standard in our clinical Routine the tissue perfusion is measured with fluorescence Imaging and Indocyaningreen (ICG). In this study the investigators use the Imaging photoplethysmography (iPPG) as new method.IPPG is an optical technique in which a conventional video camera is used to detect tiny modulations associated with blood pulsation in vessels.This technique is contactless, extremely simple, and does not affect hemodynamic processes in living organs. It is an emerging technique that allows to sense cardiovascular signals in the outer skin layers.Various research groups recently applied iPPG to monitor the vascular changes (dilatation or vasoconstriction) caused by functional tests.These experiments suggest that the normalized amplitude of the photoplethysmography (PPG) waveform can be considered as a perfusion index. More recently, our group has demonstrated the feasibility of using iPPG to assess changes in cortical blood flow in open brain neurosurgery and tissue perfusion during abdominal surgery. As Standard method ICG-Fluorescence Imaging is used. After the procedure the Perfusion data of both Systems is compared.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 28, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all gastrointestinal anastomoses

Exclusion Criteria:

• inability to consent
• allergy against indocyaningreen dye

Related Conditions & MeSH terms

• Anastomosis
• Perfusion

Intervention

Device:
• ICG fluorescence imaging technology
Indocyanine green fluorescence imaging uses fluorescence intensity to assess blood perfusion of gastrointestinal anastomoses during gastrointestinal surgery
• Imaging photoplethysmography
Imaging photoplethysmography to assess blood perfusion at gastrointestinal anastomoses during gastrointestinal surgery

Locations

Country	Name	City	State
China	Shandong Linglong Yingcheng Hospital	Yantai	Shandong
Russian Federation	Department of Faculty Surgery, Saint Petersburg State University	Saint Petersburg	Leningrad Oblast

Sponsors (2)

Lead Sponsor	Collaborator
Saint Petersburg State University, Russia	Shandong Linglong Yingcheng Hospital

Countries where clinical trial is conducted

China,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Processing of iPPG data	In preparation for recording video data, the camera was positioned in such a way that the maximum area of the frame was occupied by the tissue area under study. Thereafter, the operator adjusted the camera-lens aperture and frame exposure-time so that the average pixel value in the captured image of the tissue under study was at least 150 (out of 255), and the aperture was as closed as possible to provide greater depth of field. The duration of the video recording usually ranged from 40 to 120 s, depending on the peristaltic activity of the intestine. The recorded frames with a resolution of 752 × 480 pixels were continuously stored in a personal computer. After the recording, these frames were processed offline by using custom software implemented on the MATLAB platform (MathWorks Inc., Natick, Massachusetts). The total time required to process the recorded data on a conventional laptop was no more than 5 minutes.	After the intraoperative video is taken, within 5 minutes
Primary	Anastomotic perfusion in digestive system	Data processing of the ICG fluorescent angiography was performed by the native software implemented in the SPY system. For quantitative analysis, a frame was first determined in which the mean pixel response over the whole frame reached the maximum for the entire recording. The moment corresponding to this frame was designated as the moment of maximum tissue fluorescence. Next, a small segment of the ICG recording was selected for analysis in the interval of two seconds before the moment of maximum fluorescence and two seconds after. In one of the frames of this segment, 7 to 9 regions were selected to quantify perfusion. After determining which area has the maximum average pixel value among these selected regions, the distribution of relative perfusion (in percent) was calculated and displayed on the image of the organ under study. Spatial distribution of the perfusion measured by ICG-FA is shown in panels as brightness variations in the images.	After the intraoperative video is taken, within 5 minutes