Evaluation of Endoscopic Surgical Field Clarity Using Hot Saline Versus Lactated Ringer's Irrigation

This study is designed to determine whether Normal Saline or Lactated Ringer's irrigation is superior in maintaining superior endoscopic surgical field clarity in surgery for pituitary adenoma.

Study Overview

• Status: Recruiting
• Conditions: Irrigation
• Intervention / Treatment: Drug: Normal Saline; Drug: Lactated Ringer's Irrigation

Detailed Description

The aims of this study are to determine whether the endoscopic surgical view is objectively clearer using Normal Saline versus Lactated Ringer's Irrigation during endoscopic skull base surgery for pituitary adenoma. Other objectives include determining whether lactated Ringer's irrigation decreases total estimated blood loss and whether use of lactated Ringer's irrigation shortens surgical time.

Hot saline irrigation at 40 degrees Celcius has been shown to improve endoscopic surgical field clarity and its use is common practice in both endoscopic inflammatory sinus surgeries and skull base procedures. Saline irrigation dilutes blood in the surgical field keeping the endoscopic view clean and more bloodless and the elevated temperature promotes hemostasis.

Preliminary evidence suggests that the use of calcium-containing irrigant may further improve endoscopic surgical views. This mechanism is thought to be mediated through the activation of platelets and providing a calcium source to calcium-dependent factors in the coagulation cascade thereby promoting hemostasis. Using lactated Ringer's, a calcium-containing fluid, may result in improved surgeon visualization, decreased blood loss, and decreased complications during endoscopic approaches to the skull base.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Carl Snyderman, MD; Phone Number: 14126478186; Email: snydermanch@upmc.edu
• Study Contact Backup: Name: Benita Valappil, MPH; Phone Number: 14128641744; Email: valappilb2@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh Medical Center
      • Contact: Benita Valappil, MPH; Phone Number: 412-864-1744; Email: valappilb2@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Any patient with a primary pituitary adenoma, macro or micro adenoma.

Exclusion Criteria:

• Age <18
• Pregnancy
• Revision surgery
• Non-surgical candidate due to medical, surgical, or anesthesia contraindications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Normal Saline; This study will be a prospective double blinded randomized controlled trial. Fifteen patients will be randomly assigned to the normal saline group using a random number generator.	Drug: Normal Saline; Normal Saline at 40C will be used for the entirety of the surgery including the approach and exposure of the tumor as well as tumor resection, After surgery, two blinded skull base surgeon reviewers will rate the clarity of the endoscopic field of view at the recorded intervals. The surgical field will be graded using a widely accepted numeric integer (Boezaart) scale.
Experimental: Lactated Ringer's Irrigation; This study will be a prospective double blinded randomized controlled trial. Fifteen patients will be randomly assigned to the lactated reinger group using a random number generator.	Drug: Lactated Ringer's Irrigation; Lactated Ringers at 40C will be used for the entirety of the surgery including the approach and exposure of the tumor as well as tumor resection, After surgery, two blinded skull base surgeon reviewers will rate the clarity of the endoscopic field of view at the recorded intervals. The surgical field will be graded using a widely accepted numeric integer (Boezaart) scale.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boezaart scale rating video clips	Rating for each of the three recorded video clips per patient following tumor ablation. The Boezaart is an ordinal scale 0 = No bleeding 1 = Minimal bleeding: Not a surgical nuisance and no suction required 2 = Mild bleeding: Occasional suction required, but does not affect dissection 3 = Moderate bleeding: Slightly compromises surgical field, frequent suction required 4 = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction 5 = Massive bleeding: Prevent dissection.	10 minutes
Boezaart scale rating video clips	rating for each of the three recorded video clips per patient after 10 minutes of irrigation. The Boezaart is an ordinal scale 0 = No bleeding 1 = Minimal bleeding: Not a surgical nuisance and no suction required 2 = Mild bleeding: Occasional suction required, but does not affect dissection 3 = Moderate bleeding: Slightly compromises surgical field, frequent suction required 4 = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction 5 = Massive bleeding: Prevent dissection.	10 minutes
Boezaart scale rating video clips	rating for each of the three recorded video clips per patient at the completion of hemostasis. The Boezaart is an ordinal scale 0 = No bleeding 1 = Minimal bleeding: Not a surgical nuisance and no suction required 2 = Mild bleeding: Occasional suction required, but does not affect dissection 3 = Moderate bleeding: Slightly compromises surgical field, frequent suction required 4 = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction 5 = Massive bleeding: Prevent dissection..	10 minutes
Time	Time between tumor ablation and the completion of hemostasis, or total irrigation time for patients undergoing normal saline or Lactated Ringer's irrigation during their surgical case.	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated Blood Loss (EBL)	(EBL) per case and total operative time	15 min

Collaborators and Investigators

• Sponsor: Carl Snyderman
• Investigators: Principal Investigator: Carl Snyderman, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2022
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 3, 2021
• First Posted (Actual): December 17, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY21110081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No