Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03816514
• Other study ID #: H-1811-039-986
• Status: Completed
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: November 6, 2020

Study information

• Verified date: December 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: November 6, 2020
• Est. primary completion date: November 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Transfusion
• Hemoglobins
• Hemorrhage

Intervention

Procedure:
• SpHb monitoring
Noninvasive, continuous pulse oximetry-based hemoglobin (SpHb) monitoring
• Conventional management
Conventional management without SpHb monitoring

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Berkow L, Rotolo S, Mirski E. Continuous noninvasive hemoglobin monitoring during complex spine surgery. Anesth Analg. 2011 Dec;113(6):1396-402. doi: 10.1213/ANE.0b013e318230b425. Epub 2011 Sep 29. — View Citation

Causey MW, Miller S, Foster A, Beekley A, Zenger D, Martin M. Validation of noninvasive hemoglobin measurements using the Masimo Radical-7 SpHb Station. Am J Surg. 2011 May;201(5):592-8. doi: 10.1016/j.amjsurg.2011.01.020. — View Citation

Galvagno SM Jr, Hu P, Yang S, Gao C, Hanna D, Shackelford S, Mackenzie C. Accuracy of continuous noninvasive hemoglobin monitoring for the prediction of blood transfusions in trauma patients. J Clin Monit Comput. 2015 Dec;29(6):815-21. doi: 10.1007/s10877-015-9671-1. Epub 2015 Mar 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of deviation from the target hemoglobin range	(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)	Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Secondary	The percentage extent of deviation from the target hemoglobin range	The percentage extent of deviation of laboratory hemoglobin out of the prespecified target range	Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Secondary	Number of Point-of-care (POC) sampling during surgery	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.	Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Secondary	Accuracy of the SpHb value	Standard Laboratory hemoglobin measurement will be used as reference. Laboratory measurements will be done every 30 minute during surgery	Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Secondary	Number of patients who receive intra-operative transfusion	Number of patients who were transfused with pRBCs intraoperatively	Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Secondary	Total volume of intravenous fluids given	Total volume of intravenous fluids given intra-operatively	Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Secondary	Total volume of pRBCs transfused	Total volume of pRBCs transfused intra-operatively	Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Secondary	Time for transfusion delay	Time from the determination of transfusion to actual transfusion, in minutes	Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Secondary	Incidence of intraoperative hypotension	hypotension is defined as SBP < 80% of baseline SBP	Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
Secondary	laboratory total hemoglobin value, at postoperative day 1	total hemoglobin value measured by standard laboratory method	at postoperative day 1