Clinical trial NCT06338007: Relationship Between Hand Dynamometer Measurements, PFT, and mFI With Postoperative Outcomes
Official title: The Relationship of Preoperative Hand Dynamometer Measurement, Pulmonary Function Tests and Modified Frailty Index With Postoperative Outcomes in Patients Undergoing Lung Resection
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Complication,Postoperative
Lung Cancer
Keywords: Lung Cancer
postoperative complication
modified frailty index
pulmonary function test
hand grip strength measurement
Lead sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Complication
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Atatürk Sanatorium Training and Research Hospital
state: Keçiören
Study officials:
affiliation: Ankara Ataturk Sanatorium Training and Research Hospital
name: Gülay ÜLGER, specialist
role: PRINCIPAL_INVESTIGATOR
References: