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

NCT06338007 | Not Yet Recruiting

• 1 other identifier: 2012-KAEK-15/2702
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Complication,Postoperative; Lung Cancer

Keywords

Lung Cancer; postoperative complication; modified frailty index; pulmonary function test; hand grip strength measurement

Outcome Measures

Primary Outcomes (1)

• Complication

  Complication data for patients who underwent lung resection for malignancy during the 90-day follow-up period.

  90 days

Study Arms (2)

Complications (No)

Patients who did not experience any postoperative complications within 90 days.

Device: Hand Dynamometer; Diagnostic Test: Pulmonary Function Test; Other: Modified Frailty Index

Complications (Yes)

Patients who experienced any complications within 90 days after surgery.

Device: Hand Dynamometer; Diagnostic Test: Pulmonary Function Test; Other: Modified Frailty Index

Interventions

Hand Dynamometer DEVICE

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.

Complications (No); Complications (Yes)

Pulmonary Function Test DIAGNOSTIC_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.

Also known as: Spirometry

Complications (No); Complications (Yes)

Modified Frailty Index OTHER

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 (No); Complications (Yes)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Atatürk Chest Diseases and Chest Surgery Training and Research Hospital: lead

Study Sites (1)

Ankara Atatürk Sanatorium Training and Research Hospital

Ankara, Keçiören, 06290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Complications; Lung Neoplasms

Interventions

Respiratory Function Tests; Spirometry

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Gülay ÜLGER, specialist

  Ankara Ataturk Sanatorium Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gülay ÜLGER, specialist

CONTACT

05059532122; gulayulger@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: March 29, 2024
• Study Start: May 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)