- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT06338007
Förhållandet mellan handdynamometermätningar, PFT och mFI med postoperativa resultat
Förhållandet mellan preoperativ handdynamometermätning, lungfunktionstester och modifierat frailtyindex med postoperativa utfall hos patienter som genomgår lungresektion
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Keçiören
-
Ankara, Keçiören, Turkiet (Türkiye), 06290
- Ankara Atatürk Sanatorium Training and Research Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: OTHER
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Complications (No)
Patients who did not experience any postoperative complications within 90 days. |
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. 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.
Andra namn:
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 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. 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.
Andra namn:
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Complication
Tidsram: 90 days
|
Complication data for patients who underwent lung resection for malignancy during the 90-day follow-up period. |
90 days
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Gülay ÜLGER, specialist, Ankara Ataturk Sanatorium Training and Research Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Neoplasmer efter plats
- Neoplasmer
- Luftvägssjukdomar
- Lungsjukdomar
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Patologiska tillstånd, tecken och symtom
- Lungneoplasmer
- Postoperativa komplikationer
- Diagnostiska tekniker och procedurer
- Diagnos
- Diagnostiska tekniker, andningssystem
- Andningsfunktionstester
- Spirometri
Andra studie-ID-nummer
- 2012-KAEK-15/2702
Plan för individuella deltagardata (IPD)
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