Anemia on Sublingual Microcirculation in GDFT

NCT07583927 | Enrolling By Invitation

• 1 other identifier: 2604-Exp428
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the effects of anemia on sublingual microcirculation in patients undergoing goal-directed fluid therapy (GDFT) during surgery. The main question it aims to answer is: Does anemia, under the condition of goal-directed fluid therapy, lead to significant changes in sublingual microcirculatory parameters (such as microvascular density and perfusion)? Participants will include 54 patients scheduled for elective open radical gastrectomy (27 anemic vs. 27 non-anemic). Sublingual microcirculation will be assessed using a side-stream dark field imaging device at four time points: before anesthesia induction (T0), after induction (T1), after specimen removal (T2), and after anastomosis completion (T3). All patients will receive intraoperative GDFT guided by pulse pressure variation (PPV) and cardiac output (CO) via the Vigileo-FloTrac system.

Conditions

Macro-microcirculation Uncoupling; Anemia in Patients Undergoing Gastric Cancer Surgery Under Goal-directed Fluid Therapy

Keywords

Anemia; Sublingual Microcirculation; Goal-Directed Fluid Therapy (GDFT); Macro-microcirculation Uncoupling; Radical Gastrectomy

Outcome Measures

Primary Outcomes (4)

• Total Vessel Density (TVD)

  Total vessel density is defined as total vessel length (mm) per unit area (mm²), calculated as: TVD = total vessel length / area of the field of view. Sublingual microcirculation videos are acquired using a side-stream dark field imaging device (MicroScan, MicroVision Medical). Vessels with diameter \<20 μm are analyzed using MicroSee image management software. Three videos are recorded at each measurement time point, and the average value is reported.

  before anesthesia induction (T0), after anesthesia induction (T1), after specimen removal (T2), and after anastomosis completion (T3).

• Perfused Vessel Density (PVD)

  Perfused vessel density is defined as perfused vessel length (mm) per unit area (mm²), calculated as: PVD = perfused vessel length / area of the field of view. Perfusion is defined as continuous or sluggish flow (score ≥2 on the microvascular flow scale). Sublingual microcirculation videos are acquired using a side-stream dark field imaging device. Vessels with diameter \<20 μm are analyzed using MicroSee software. Three videos are recorded at this time point, and the average PVD value is reported.

  before anesthesia induction (T0), after anesthesia induction (T1), after specimen removal (T2), and after anastomosis completion (T3).

• Proportion of Perfused Vessels (PPV)

  Proportion of perfused vessels is defined as the percentage of total vessel length that is perfused, calculated as: PPV (%) = (perfused vessel length / total vessel length) × 100%. Perfusion is defined as continuous or sluggish flow (score ≥2 on the microvascular flow scale). Sublingual microcirculation videos are acquired using a side-stream dark field imaging device. Vessels with diameter \<20 μm are analyzed using MicroSee software. Three videos are recorded at this time point, and the average PPV is reported.

  before anesthesia induction (T0), after anesthesia induction (T1), after specimen removal (T2), and after anastomosis completion (T3).

• Microvascular Flow Index (MFI)

  Microvascular flow index is a semi-quantitative measure of microvascular flow velocity. The field of view is divided into four quadrants. Flow in each quadrant is scored as: 0 = no flow, 1 = intermittent flow, 2 = sluggish flow, 3 = continuous flow. MFI is calculated as the average score across the four quadrants (range 0-3, with higher scores indicating better microvascular flow). Sublingual microcirculation videos are acquired using a side-stream dark field imaging device. Vessels with diameter \<20 μm are analyzed. Three videos are recorded at this time point, and the average MFI is reported.

  before anesthesia induction (T0), after anesthesia induction (T1), after specimen removal (T2), and after anastomosis completion (T3).

Study Arms (2)

Anemic Group

Patients with preoperative hemoglobin (Hb) ≤ 10 g/dL scheduled for elective open radical gastrectomy. All patients receive standardized goal-directed fluid therapy (GDFT) and undergo sublingual microcirculation assessment at four time points: before anesthesia induction (T0), after induction (T1), after specimen removal (T2), and after anastomosis completion (T3).

Other: No intervention

Non-anemic Group

Patients with preoperative hemoglobin (Hb) \> 10 g/dL scheduled for elective open radical gastrectomy. All patients receive standardized goal-directed fluid therapy (GDFT) and undergo sublingual microcirculation assessment at four time points: before anesthesia induction (T0), after induction (T1), after specimen removal (T2), and after anastomosis completion (T3).

Other: No intervention

Interventions

No intervention OTHER

This is an observational study. Participants are assigned to groups based on their preoperative anemia status (hemoglobin ≤10 g/dL vs. \>10 g/dL). No experimental intervention is administered. All patients receive standardized clinical care including goal-directed fluid therapy and open radical gastrectomy as per routine practice.

Anemic Group; Non-anemic Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients (age ≥18 years) scheduled for elective open radical gastrectomy for gastric cancer at Fudan University Shanghai Cancer Center. Patients are assigned to two groups based on their preoperative hemoglobin level: anemic group (Hb ≤10 g/dL) and non-anemic group (Hb \>10 g/dL). All patients undergo standardized goal-directed fluid therapy during surgery and receive general anesthesia with endotracheal intubation.

You may qualify if:

• Scheduled for elective open radical gastrectomy
• Age ≥ 18 years
• ASA physical status I-III
• Undergoing general anesthesia with endotracheal intubation

You may not qualify if:

• Untreated ischemic heart disease or severe cardiovascular disease
• Acute or chronic respiratory failure, severe asthma, pulmonary bullae, pneumothorax, emphysema, bronchopleural fistula
• Oral or tongue disorders
• Scheduled for laparoscopic surgery
• Inability to position or observe the patient's head during surgery
• Refusal to participate after entering the operating room
• Intraoperative life-threatening events
• Hemodynamic instability during surgery

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Shanghai Cancer Center, Fudan University

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician of Anesthesiology

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)