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Anemia on Sublingual Microcirculation in GDFT

Effects of Anemia on Sublingual Microcirculation in Patients Undergoing Goal-Directed Fluid Therapy: A Prospective Observational Study

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07583927
Enrollment
54
Registered
2026-05-13
Start date
2026-05-01
Completion date
2026-08-01
Last updated
2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

OTHERNo intervention

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.

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Total Vessel Density (TVD)before anesthesia induction (T0), after anesthesia induction (T1), after specimen removal (T2), and after anastomosis completion (T3).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.
Perfused Vessel Density (PVD)before anesthesia induction (T0), after anesthesia induction (T1), after specimen removal (T2), and after anastomosis completion (T3).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.
Proportion of Perfused Vessels (PPV)before anesthesia induction (T0), after anesthesia induction (T1), after specimen removal (T2), and after anastomosis completion (T3).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.
Microvascular Flow Index (MFI)before anesthesia induction (T0), after anesthesia induction (T1), after specimen removal (T2), and after anastomosis completion (T3).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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026