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

NCT06704256 | Recruiting

• 1 other identifier: STUDY-24-00751
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Frailty

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Patients Undergoing Non-Oncologic and Neck surgery

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10028, United States

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gabriela Hernandez

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriela Hernandez, MD PhD

CONTACT

814-769-1104; Gabriela.hernandezmeza@mountsinai.org

Mingyang Gray, MD

CONTACT

Mgray@nyee.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Facial Plastic and Reconstructive Surgery Department of Otolaryngology - Head and Neck Surgery

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: October 28, 2024
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): October 23, 2026
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• 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).

Locations

US (1)