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NCT Number: NCT07583927

Anemia on Sublingual Microcirculation in GDFT

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.

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Key information

Conditions

Anemia in Patients Undergoing Gastric Cancer Surgery Under Goal-directed Fluid Therapy Anemia Hematologic Diseases Hemic and Lymphatic Diseases Macro-microcirculation Uncoupling

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Cancer Center, Fudan University

Shanghai, Shanghai Municipality, 200030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Total Vessel Density (TVD)

    Time frame: 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.

  2. Perfused Vessel Density (PVD)

    Time frame: 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.

  3. Proportion of Perfused Vessels (PPV)

    Time frame: 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.

  4. Microvascular Flow Index (MFI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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