Relationship Between Hand Dynamometer Measurements, PFT, and mFI With Postoperative Outcomes

The Relationship of Preoperative Hand Dynamometer Measurement, Pulmonary Function Tests and Modified Frailty Index With Postoperative Outcomes in Patients Undergoing Lung Resection

The study will take place at SBÜ Ankara Atatürk Sanatorium Training and Research Hospital and will include 100 patients over the age of 40 who are scheduled for lung malignancy surgery after 01 April 2024. Informed consent will be obtained from all patients, who will be assigned a number from 1 to 100.

For patients over 40 years of age who are scheduled to undergo lung malignancy resection surgery, demographic data including age, gender, height, weight, body mass index (BMI), diagnosis, comorbidities, and ASA (American Society of Anaesthesiologist) score will be recorded. In addition, hand grip strength measurement, pulmonary function test, and modified frailty index (a scoring system that includes 11 parameters) will be recorded prior to surgery. Intraoperative and postoperative complications will be documented. The duration of the patient's stay in the intensive care unit, chest tube removal, length of hospital stay, and postoperative complications will also be recorded. A follow-up call will be made to the patient by the responsible researcher 90 days after the operation to inquire about any complications that may have developed within that time frame.

The study aims to investigate the relationship between preoperative hand grip strength measurement, pulmonary function test analysis (PFT), and modified frailty index with the duration of intensive care unit stay, chest tube withdrawal time, hospital stay, and postoperative complications in patients undergoing lung resection due to malignancy.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer; Complication,Postoperative
• Intervention / Treatment: Device: Hand Dynamometer; Diagnostic test: Pulmonary Function Test; Other: Modified Frailty Index

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

Contacts and Locations

• Study Contact: Name: Gülay ÜLGER, specialist; Phone Number: +9 05059532122; Email: gulayulger@gmail.com

Study Locations

• Turkey
  • Keçiören
    • Ankara, Keçiören, Turkey, 06290
      • Ankara Atatürk Sanatorium Training and Research Hospital
      • Sub-Investigator: Onur KÜÇÜK, specialist
      • Contact: Gülay ÜLGER, specialist; Phone Number: +9 05059532122; Email: gulayulger@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

During a 3-month period, we calculated that we needed 91 patients to achieve a 95% confidence level with a margin of error of ±5%. This calculation was based on the assumption that 40% of all surgical patients in our clinic had malignant lung resection. We selected a sample size of 100, taking into account possible non-study factors.

Description

Inclusion Criteria:

• All patients over the age of 40 who will undergo lung resection due to malignancy

Exclusion Criteria:

• Patients undergoing emergency surgery
• Patients with missing preoperative measurements
• Patients with missing 90-day follow-up data

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Complications (No); Patients who did not experience any postoperative complications within 90 days.	Device: Hand Dynamometer; Hand grip strength will be measured using a hand dynamometer. Research has demonstrated that hand grip strength is correlated with muscle strength in the upper extremities, as well as overall body and pulmonary muscle strength.; Diagnostic test: Pulmonary Function Test; Spirometry is a physiological test that measures the ability to inhale and exhale air relative to time. Spirometry is a diagnostic test of several common respiratory disperses such as asthma and chronic obstructive pulmonary disease (COPD). It is also instrumental in monitoring the progression of various respiratory disorders. The main results of spirometry are forced vital capacity (FVC), forced expiratory volume exhaled in the first second (FEV1), and the FEV1/FVC ratio. Pulmonary Function Test analysis values (FEV1, FVC and FEV1 /FVC) will be used.; Other Names: Spirometry; Other: Modified Frailty Index; The modified frailty index is a valuable preoperative risk assessment tool that can be used to assess the risk of both morbidity and mortality in patients undergoing surgery. It is calculated based on 11 parameters.
Complications (Yes); Patients who experienced any complications within 90 days after surgery.	Device: Hand Dynamometer; Hand grip strength will be measured using a hand dynamometer. Research has demonstrated that hand grip strength is correlated with muscle strength in the upper extremities, as well as overall body and pulmonary muscle strength.; Diagnostic test: Pulmonary Function Test; Spirometry is a physiological test that measures the ability to inhale and exhale air relative to time. Spirometry is a diagnostic test of several common respiratory disperses such as asthma and chronic obstructive pulmonary disease (COPD). It is also instrumental in monitoring the progression of various respiratory disorders. The main results of spirometry are forced vital capacity (FVC), forced expiratory volume exhaled in the first second (FEV1), and the FEV1/FVC ratio. Pulmonary Function Test analysis values (FEV1, FVC and FEV1 /FVC) will be used.; Other Names: Spirometry; Other: Modified Frailty Index; The modified frailty index is a valuable preoperative risk assessment tool that can be used to assess the risk of both morbidity and mortality in patients undergoing surgery. It is calculated based on 11 parameters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication	Complication data for patients who underwent lung resection for malignancy during the 90-day follow-up period.	90 days

Collaborators and Investigators

• Sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
• Investigators: Principal Investigator: Gülay ÜLGER, specialist, Ankara Atatürk Sanatorium Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: March 24, 2024
• First Submitted That Met QC Criteria: March 24, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: postoperative complication; Lung Cancer; pulmonary function test; modified frailty index; hand grip strength measurement
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 2012-KAEK-15/2702

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: No
• Studies a U.S. FDA-regulated device product: No