SCM Muscle as a Marker for Frailty in Patients Undergoing ENT Surgery

This study focuses on evaluating the relationship between physical frailty and measurements of the muscles of the neck in patients undergoing non-cancer Head and Neck surgery.

Study Overview

• Status: Recruiting
• Conditions: Frailty

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Gabriela Hernandez, MD PhD; Phone Number: 814-769-1104; Email: Gabriela.hernandezmeza@mountsinai.org
• Study Contact Backup: Name: Mingyang Gray, MD; Email: Mgray@nyee.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10028
      • Recruiting
      • Mount Sinai Hospital
      • Principal Investigator: Mingyang Gray, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Non-oncologic patients presenting for head and neck surgery with available neck CT scans

Description

Inclusion Criteria:

• Non-oncologic patients presenting for head and neck surgery with available neck CT scans.

Exclusion Criteria:

• Patients undergoing cancer surgery
• Patients under18 years of age
• Patients without pre-surgical CT-scans of the head and neck

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients Undergoing Non-Oncologic and Neck surgery; Non-oncologic patients presenting for head and neck surgery with available neck CT scans.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal muscle size	Skeletal muscle derived measures of size of neck skeletal musculature. No maximum or minimum.	End of study at 6 months
Skeletal muscle density	Skeletal muscle derived measures of density of neck skeletal musculature. No maximum or minimum.	End of study at 6 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Gabriela Hernandez, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2024
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): October 23, 2026

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Estimated): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: STUDY-24-00751

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Immediately following publication. No end date.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.

Any purpose. Data are available indefinitely at (Link to be included in the URL field below).

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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