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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06338007
• Other study ID #: 2012-KAEK-15/2702
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2024
• Source: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
• Contact: Gülay ÜLGER, specialist
• Phone: 05059532122
• Email: gulayulger[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complication,Postoperative
• Lung Cancer
• Postoperative Complications

Intervention

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:
• 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.

Locations

Country	Name	City	State
Turkey	Ankara Atatürk Sanatorium Training and Research Hospital	Ankara	Keçiören

Sponsors (1)

Lead Sponsor	Collaborator
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication	Complication data for patients who underwent lung resection for malignancy during the 90-day follow-up period.	90 days