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

NCT ID: NCT06338007

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Complication,Postoperative Lung Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Complications (No)

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

Hand Dynamometer

Intervention Type 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.

Pulmonary Function Test

Intervention Type 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.

Modified Frailty Index

Intervention Type 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 (Yes)

Patients who experienced any complications within 90 days after surgery.

Hand Dynamometer

Intervention Type 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.

Pulmonary Function Test

Intervention Type 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.

Modified Frailty Index

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type OTHER

Other Intervention Names

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Spirometry

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gulay Ulger

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gülay ÜLGER, specialist

Role: PRINCIPAL_INVESTIGATOR

Ankara Ataturk Sanatorium Training and Research Hospital

Locations

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Ankara Atatürk Sanatorium Training and Research Hospital

Ankara, Keçiören, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Gülay ÜLGER, specialist

Role: CONTACT

05059532122 ext. +9

Facility Contacts

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Gülay ÜLGER, specialist

Role: primary

05059532122 ext. +9

Other Identifiers

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2012-KAEK-15/2702

Identifier Type: -

Identifier Source: org_study_id

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