ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT05973201 (AVATAR) के लिए श्वसन विकार, फेफड़े का संक्रमण वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
Evaluation of Virtual Reality to Reduce Anxiety, Pain and Duration of Non-emergency Vigile Bronchial Fibroscopy (AVATAR) 120 वर्चुअल
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT05973201 (AVATAR) एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो श्वसन विकार, फेफड़े का संक्रमण से जुड़ा हुआ है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 19 अक्तूबर 2023 को हुई थी, और इसमें कुल 120 प्रतिभागियों के नामांकन की योजना है। ग्रेटर पेरिस यूनिवर्सिटी हॉस्पिटल्स इस परीक्षण का नेतृत्व कर रहे हैं और इसके 26 अक्तूबर 2025 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 4 दिसंबर 2024 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
Bronchial fibroscopy (BF) is a routine practice examination in critical care areas. It can be useful either for the diagnosis of the causal pathology of respiratory distress or for the diagnosis of lung infection, sometimes nosocomial. In patients in spontaneous and conscious ventilation, BF are performed vigil after local anesthesia according to the recommendations of the Société de Pneumologie de langue Française. ...और दिखाएँ
विस्तृत विवरण
Bronchial fibroscopy (BF) is an invasive examination mainly performed in vigilant patients under local anesthesia very regularly performed in patients hospitalized in critical care. Despite local anesthesia, and paradoxically also because of local anesthesia that makes the airflow in the upper airway imperceptible, BF is an anxiety-provoking and sometimes uncomfortable examination. Drug options are offered by physici...और दिखाएँ
आधिकारिक शीर्षक
Evaluation De La Réalité Virtuelle Pour Réduire L'anxiété, La Douleur Et De La Durée D'une Fibroscopie Bronchique Vigile Non Urgente En Soins Critiques
स्वास्थ्य स्थितियां
श्वसन विकारफेफड़े का संक्रमणअन्य अध्ययन आईडी
- AVATAR
- APHP220834
- PHRIP-21-0055 (अन्य अनुदान/वित्त पोषण संख्या) (French ministry of health)
- 2023-A00163-42 (अन्य पहचानकर्ता) (IDRCB)
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2023-10-19
अंतिम अद्यतन प्रकाशित
2024-12-04
अध्ययन की समाप्ति तिथि (अनुमानित)
2025-10-26
नामांकन (अनुमानित)
120
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
भर्ती जारी
प्रमुख शब्द
Virtual reality
Pulmonary fibroscopy
Anxiety
Pain
Intensive care
Pulmonary fibroscopy
Anxiety
Pain
Intensive care
प्राथमिक उद्देश्य
सहायक देखभाल
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
प्रयोगात्मकinterventional arm Fibroscopy performed under local anesthesia with immersion in a virtual reality scenario | वर्चुअल रियलिटी हेडसेट A HEALTHY MIND® brand VR headset is dedicated to the study. The kit includes a noise-reducing audio headset, a face mask diffusing the visual part, a touchscreen tablet connected to the two VR headset systems, and a microphone connected to the tablet.
The available software allows patients to choose between 5 natural environments in which a hypnotic speech is broadcast, available in several languages (French, Englis...और दिखाएँ |
कोई हस्तक्षेप नहींConventional arm Fibroscopy performed under local anesthesia without immersion in a virtual reality scenario | निर्दिष्ट नहीं |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Maximum value of patient's anxiety experienced during BF assessed by the visual analogue scale (VAS) immediately after the BF | The visual analogue scale is a rating scale in the form of a 10 cm strip graduated in mm that can be presented horizontally or vertically. On the face presented to the patient, there is a cursor that he mobilizes on a straight line with one end corresponding to "absence of anxiety" and the other to "maximum anxiety imaginable". The patient must then place the cursor where he locates his anxiety. VAS ranges from 0 to 100 mm. | Immediately after BF |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
The relative change of patient's anxiety before and after BF assessed by the STAI-A scale (state anxiety scale) | The Spielberger State-Trait Anxiety Inventory (STAI) is a 40-item self-report measure of anxiety using a 4-point Likert-type scale (from 1 to 4 points) for each item. It has two scales: State anxiety, i.e. how one feels at the moment; and Trait anxiety, i.e. how one generally feels. Both scales consist of 20 items. The state scale has 10 reverse-scored items, the trait scale has 7. Scores of both scales ranges from 20 to 80. | Immediately after BF |
Patient's anxiety when leaving the intensive care unit (or on the 7th day at the latest, after BF) assessed by the visual analogue scale (VAS) | The visual analogue scale is a rating scale in the form of a 10 cm strip graduated in mm that can be presented horizontally or vertically. On the face presented to the patient, there is a cursor that he mobilizes on a straight line with one end corresponding to "absence of anxiety" and the other to "maximum anxiety imaginable". The patient must then place the cursor where he locates his anxiety. VAS ranges from 0 to 100 mm. | When leaving the intensive care unit or on the 7th day at the latest, post BF |
Maximum value of patient's pain experienced during BF assessed by the visual analogue scale (VAS) immediately after the FB | The visual analogue scale is a rating scale in the form of a 10 cm strip graduated in mm that can be presented horizontally or vertically. On the face presented to the patient, there is a cursor that he mobilizes on a straight line with one end corresponding to "absence of pain" and the other to "maximum pain imaginable". The patient must then place the cursor where he locates his pain. VAS ranges from 0 to 100 mm. | Immediately after BF |
Patient's pain experienced during BF evaluated by the nursing staff assessed by the ALGOPLUS scale immediately after the FB | The ALGOPLUS scale was specifically developed to evaluate and manage acute pain in the elderly in all situations in which reliable self-assessment is not feasible. The scale is composed of 5 items (observational areas/domains). Each item checked "yes" is accorded 1 point and the sum of checked items gives a total score ranging from 1 to 5. | Immediately after BF |
The relative change of patient's maximum pulse measured during BF compared to pulse measured before BF | The relative change of patient's maximum pulse measured during BF compared to pulse measured before BF | Immediately after BF |
The relative change of patient's maximum respiratory rate measured during BF compared to respiratory rate measured before BF | The relative change of patient's maximum respiratory rate measured during BF compared to respiratory rate measured before BF | Immediately after BF |
The relative change of patient's maximum blood pressure measured during BF compared to blood pressure measured before BF | The relative change of patient's maximum blood pressure measured during BF compared to blood pressure measured before BF | Immediately after BF |
The duration of BF (in minutes) from the start of the local anesthesia to the permanent removal of the fibroscopy | The duration of BF (in minutes) from the start of the local anesthesia to the permanent removal of the fibroscopy | Immediately after BF |
Tolerance to the VR assessed by a questionnaire measuring the side effects of the VR | The questionnaire items lists the side effects of the VR (8 items with 3 answer categories: yes, no and do not know). | 1 day post BF |
Patient anxiety experienced before BF evaluated by the nursing staff assessed by Hamilton scale | The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient\'s anxiety.The scale consists of 14 items designed to assess the severity of a patient\'s anxiety. | Before BF |
The total dose of sedative and anxiolytic drugs administered during BF | The total dose of midazolam, alprazolam, hydroxyzine, diprivan, stage II or III analgesics administered during BF | Immediately after BF |
The quality of FB (specific questionnaire completed by the physician describing the quality of exploration, the possibility of taking samples and the satisfaction VAS). | A specific questionnaire completed by the physician in charge of the BF will be used describing the quality of the exploration and the possibility of taking samples | Immediately after BF |
Remote patient satisfaction with FB measured using the e-SATIS ?questionnaire (Haute Autorité de Santé "prise en charge" section), and the answer to the single question: "Would you have a bronchial fibroscopy again in the future) | E-SATIS is an experience and satisfaction questionnaire, in which all patients are invited to participate, following treatment in a health establishment, hospital or clinic. The questionnaire is validated by the French Haute autorité de santé. The \"patient care\" section of the questionnaire was used to assess remote patient\'s satisfaction on the BF procedure. For each responding patient, a score ranging from 1 \[bad experience\] to 5 \[excellent experience\] (transformed into a value from 0 to 100) is given to each of his answers. | 7 days post BF |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
- Adults (over 18 years of age)
- Hospitalized in a critical care unit (intensive care and intensive care)
- Conscious (Glasgow score >13)
- Spontaneous ventilation
- Requiring the realization of a FB
- First BF during hospitalization
- Having signed a consent to participate in the study
- Affiliation to social security
- Non-French-speaking patient
- Protected minors or adults who cannot consent to participate
- People with major neurocognitive impairment
- Patient refusing to participate in the study
- Patient on State medical aid
- Patient under guardianship or curatorship or under judicial protection
- BF for a vital emergency
- Prior inclusion in the study
- Pregnant or breastfeeding women
- Presence of a tracheostomy or tracheostomy
- Participation in other intervention research
- Epilepsy
- Visual impairment (blindness) or severe hearing impairment (hearing loss, deafness) that does not allow the use of the helmet
- Psychiatric pathologies such as delusional disorders, hallucinations or schizophrenia.
- Autism spectrum disorders
- Patient sensitive to motion sickness
- Refractory migraine under treatment
अध्ययन केंद्रीय संपर्क
संपर्क: Aurélie ZINDJIRDJIAN, +33 1 44 84 17 64, [email protected]
संपर्क: Youcef SEKOUR, +33 1 56 09 58 23, [email protected]
5 1 देशों में अध्ययन स्थान
CHI Aix en Provence, Aix-en-Provence, 13100, France
Youssef TRIGUI, MD, संपर्क, +334 42 33 90 33, [email protected]
Youssef TRIGUI, MD, संपर्क
भर्ती जारी
CHU Dijon, Dijon, 21079, France
Marjolaine GEORGES, MD, संपर्क, +333 80 29 37 72, [email protected]
Marjolaine GEORGES, MD, संपर्क
भर्ती जारी
Hôpital Le Kremlin Bicêtre, Le Kremlin-Bicêtre, 94270, France
वापस लिया गया
Hôpital européen Georges Pompidou - AP-HP, Paris, 75015, France
Alexandra GOMES, Nurse, संपर्क, +331 56 09 25 64, [email protected]
Anaïs RASTELLO, Nurse, संपर्क
भर्ती जारी
Hôpital Foch, Suresnes, 92150, France
Floriane Costani, Nurse, संपर्क, +33 1 46 25 29 07, [email protected]
Floriane Costani, Nurse, संपर्क
अभी भर्ती शुरू नहीं