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Lo studio clinico NCT06919185 (RAPIDLY) per Diaphragmatic Plication, Paralisi diaframmatica, Diaphragmatic Eventration è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Short- and Long-term Effects of Robot-assisted Plication in Diaphragmatic Paralysis (RAPIDLY) 50 Osservazionale
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La sperimentazione clinica NCT06919185 (RAPIDLY) è uno studio osservazionale per Diaphragmatic Plication, Paralisi diaframmatica, Diaphragmatic Eventration, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 maggio 2025, con l'obiettivo di raggiungere 50 partecipanti. Sotto la guida di Uppsala County Council, Sweden, dovrebbe concludersi entro il 1 dicembre 2031. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 11 aprile 2025.
Sommario breve
Diaphragmatic paralysis may lead to severe symptoms such as breathlessness and reduced physical capacity.
Diaphragmatic plication using Robotic-Assisted Thoracic Surgery (RATS) is a minimally invasive surgical technique developed to improve lung function by correcting diaphragmatic elevation.
While its benefits have been reported in retrospective reports, prospective studies are lacking.
This prospective observati...
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Assessments
Patient characteristics:
Age, sex, height, and weight will be recorded. Body mass index (BMI) is calculated by dividing a person's weight by their height in meters squared.
Aetiology of diaphragmatic paralysis, relevant co-morbidities and use of long-term oxygen therapy and/or mechanical ventilation will be recorded.
The date for symptom debut, if known, is recorded. Smoking history is defined as curr...
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Short- and Long-term Effects of Robot-assisted Plication in Diaphragmatic Paralysis - the Prospective RAPIDLY-study
Patologie
Diaphragmatic PlicationParalisi diaframmaticaDiaphragmatic EventrationPubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- RAPIDLY
- 2025-01028-01
Numero NCT
Data di inizio (effettiva)
2025-05
Ultimo aggiornamento pubblicato
2025-04-11
Data di completamento (stimata)
2031-12
Arruolamento (previsto)
50
Tipo di studio
Osservazionale
Stato
Non ancora in arruolamento
Parole chiave
RATS
robot-assisted thoracic surgery
plication
dyspnea
thoracotomy
robot-assisted thoracic surgery
plication
dyspnea
thoracotomy
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Patients accepted for Robot-assisted diaphragmatic plication Patients with symptomatic unilateral diaphragmatic paralysis persisting for ≥1 year accepted for Robot-assisted diaphragmatic plication at 5 Swedish University Hospitals, Gothenburg, Linköping, Lund, Umeå, and Uppsala | N.D. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
6-minute walking distance (6MWD). | The patients are asked to walk as far as possible on a flat, straight surface for six minutes, and the total distance walked is measured. | From enrollment to end of observation att 3 years. |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
The modified Borg Scale | A tool with a range from 0 to 10 used to measure an individual's perceived level of breathlessness or muscle fatigue during physical activity, where 0 represents no breathlessness, and 10 represents maximal breathlessness | From enrollment to end of observation att 3 years. |
The modified Medical Research Council (mMRC) dyspnea scale | The mMRC is used to assess the severity of breathlessness. The scale ranges from 0 to 4, with higher scores indicating more significant breathlessness | From enrollment to end of observation att 3 years. |
The Dyspnea-12 questionnaire | The Dyspnea-12questionnaire is used to measure the severity and quality of breathlessness in individuals with respiratory or cardiovascular conditions. It assesses dyspnea's physical and emotional aspects, providing a comprehensive picture of how breathlessness affects a person's life. It consists of 12 items, each with a scale range between 0 (no dyspnea) and 3 (severe dyspnea) | From enrollment to end of observation att 3 years. |
The EQ-5D questionnaire | The EQ-5D is one of the most widely used tools for assessing health-related quality of life. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These dimensions create a descriptive profile that can be converted into a single summary index, where a score of 1.0 indicates perfect health. Additionally, the tool includes a Visual Analog Scale (VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health), for self-assessment of overall health status | From enrollment to end of observation att 3 years. |
Spirometry | Spirometry will be conducted 15 minutes after bronchodilation (inhalation of 200 µg salbutamol) in both supine and upright positions. Body plethysmography and single-breath DLCO measurement will be performed. Predicted values will be determined using reference equations from the Global Lung Function Initiative | From enrollment to end of observation att 3 years. |
One-minute sit-to-stand test (1-MSTST) | This test assesses a person's functional exercise capacity by recording the number of full sit-to-stand repetitions completed in 60 seconds | From enrollment to end of observation att 3 years. |
The Maximal Inspiratory Pressure (MIP) test | MIP is a respiratory test that measures the strength of the inspiratory muscles, particularly the diaphragm. By inhaling as forcefully as possible in a handheld device, the maximum negative pressure generated is recorded | From enrollment to end of observation att 3 years. |
Blood gas analysis | A capillary or arterial blood gas analysis obtains the partial pressure of oxýgen (O2). | From enrollment to end of observation att 3 years. |
Blood gas analysis | A capillary or arterial blood gas analysis obtains the partial pressure of carbon dioxide (CO2) | From enrollment to end of observation att 3 years. |
Blood gas analysis | A capillary or arterial blood gas analysis obtains the levels of base excess (BE) | From enrollment to end of observation att 3 years. |
Pulse oximetry | Obtains oxygen saturation. | From enrollment to end of observation att 3 years. |
Chest X-ray | Chest X-rays are acquired in full inspiration and expiration in frontal and lateral views. The distance from the most cranial part of the lung to the highest part of the diaphragm in both frontal and side views are measured separately. | From enrollment to end of observation att 3 years. |
Computerised tomography (CT) of Thorax | A CT with a standard protocol to identify and quantify lower lobe atelectasis. | From enrollment to end of observation att 3 years. |
Adverse events | Operating time, chest-drain duration, length of hospitalisation, per- and postoperative complications such as pain, bleeding and infections, 30-day readmission and 30-days mortality are recorded. | 30 days post-operatively |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Patients with symptomatic unilateral diaphragmatic paralysis persisting for ≥1 year
- Patients are scheduled for RATS at thoracic surgery clinics in five Swedish university hospitals (Gothenburg, Linköping, Lund, Umeå, and Uppsala).
- Inability to complete forms in Swedish
- Neuromuscular disease as the cause of diaphragmatic paralysis
- Other significant causes of dyspnea
- Impaired physical capacity from other causes than diaphragmatic paralysis.
Uppsala County Council, SwedenUniversità di UppsalaParte responsabile dello studio
Andreas Palm, Investigatore principale, Associate Professor, Uppsala County Council, Sweden
Contatti principali dello studio
Contatto: Andreas Palm, MD, PhD, +46 70 3573595, [email protected]
Contatto: Marie Mannberg, Research nurse, +46 18 611 40 68, [email protected]
1 Centri dello studio in 1 paesi
Department of Medical Sciences, Lung-, Allergy-, and Sleep Research, Uppsala University/Uppsala University Hospital, Uppsala, 75185, Sweden
Andreas Palm, Contatto, 0703573595, [email protected]