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Completed

NCT Number: NCT03816514

Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range

The primary aim of this study is to evaluate whether pulse oximetry based noninvasive hemoglobin (SpHb) monitoring can reduce the incidence of hemoglobin (Hb) level out of the target range in adult patients undergoing major surgery with the potential risk of bleeding.

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Key information

Conditions

Hemoglobins Blood Transfusion Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul national university hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients with ASA physical status class I, II, III, who scheduled to undergo elective non-cardiac major surgery with more than moderate risk of bleeding under general anesthesia or spinal anesthesia.
  • Eligible Surgery include: Spine surgery, bone tumor surgery, Total Hip Replacement, ovarian cancer surgery, cervical cancer surgery, radical cystectomy, open retroperitoneal mass excision, Radical Retropubic Prostatectomy, explorative laparotomy for abdominal mass excision, abdominal aortic aneurysm repair
  • Patients who are requiring an arterial catheter as a part of their standard care.

Exclusion criteria

  • Patients with preexisting deformity or skin condition that would impede sensor placement
  • Patients with allergies to the adhesive sensor material
  • Patients with uncorrected preoperative anemia (preoperative hemoglobin < 7 g/dL)
  • Patients who were not suitable for participation in the opinion of the study investigator.

Treatment and study plan

SpHb monitoring

Procedure

Noninvasive, continuous pulse oximetry-based hemoglobin (SpHb) monitoring

Conventional management

Procedure

Conventional management without SpHb monitoring

Primary outcomes

  1. The incidence of deviation from the target hemoglobin range

    Time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia

    (The number of laboratory samples with the result hemoglobin concentrations were out of the target range)/(Total number of laboratory samples that performed during intra-operative periods)

Secondary outcomes

  1. The percentage extent of deviation from the target hemoglobin range

    Time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia

    The percentage extent of deviation of laboratory hemoglobin out of the prespecified target range

  2. Number of Point-of-care (POC) sampling during surgery

    Time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia

    Number of Point-of-care (POC) sampling for measurement of hemoglobin concentration. In SpHb group, POC sampling will be done according to SpHb level. In control group, POC sampling will be done at discretion of anesthesiologist.

  3. Accuracy of the SpHb value

    Time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia

    Standard Laboratory hemoglobin measurement will be used as reference. Laboratory measurements will be done every 30 minute during surgery

  4. Number of patients who receive intra-operative transfusion

    Time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia

    Number of patients who were transfused with pRBCs intraoperatively

  5. Total volume of intravenous fluids given

    Time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia

    Total volume of intravenous fluids given intra-operatively

  6. Total volume of pRBCs transfused

    Time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia

    Total volume of pRBCs transfused intra-operatively

  7. Time for transfusion delay

    Time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia

    Time from the determination of transfusion to actual transfusion, in minutes

  8. Incidence of intraoperative hypotension

    Time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia

    hypotension is defined as SBP < 80% of baseline SBP

  9. laboratory total hemoglobin value, at postoperative day 1

    Time frame: at postoperative day 1

    total hemoglobin value measured by standard laboratory method

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Use of Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range During Major Surgery: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 25, 2019
Registry last updated
Dec 22, 2020

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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