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Forholdet mellom hånddynamometermålinger, PFT og mFI med postoperative utfall

Forholdet mellom preoperativ hånddynamometermåling, lungefunksjonstester og modifisert skrøpelighetsindeks med postoperative utfall hos pasienter som gjennomgår lungereseksjon

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.

Studieoversikt

Studietype

Observasjonsmessig

Registrering (Faktiske)

100

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Keçiören
      • Ankara, Keçiören, Tyrkia (Türkiye), 06290
        • Ankara Atatürk Sanatorium Training and Research Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: OTHER
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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.

Andre navn:
  • Spirometri

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.

Andre navn:
  • Spirometri

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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Complication
Tidsramme: 90 days

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

90 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Gülay ÜLGER, specialist, Ankara Ataturk Sanatorium Training and Research Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2024

Primær fullføring (Faktiske)

30. oktober 2024

Studiet fullført (Faktiske)

30. oktober 2024

Datoer for studieregistrering

Først innsendt

24. mars 2024

Først innsendt som oppfylte QC-kriteriene

24. mars 2024

Først lagt ut (Faktiske)

29. mars 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. april 2024

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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