Unique ID issued by UMIN | UMIN000053855 |
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Receipt number | R000061465 |
Scientific Title | Preoperative steroid administration effects after rigid bronchoscopic intervention in patients with superior vena cava syndrome: a prospective observational study |
Date of disclosure of the study information | 2024/03/14 |
Last modified on | 2024/03/14 00:26:11 |
Preoperative steroid administration effects after rigid bronchoscopic intervention in patients with superior vena cava syndrome: a prospective observational study
The effect of preoperative administration of steroids in patients with superior vena cava syndrome who underwent rigid bronchoscopic intervention
Preoperative steroid administration effects after rigid bronchoscopic intervention in patients with superior vena cava syndrome: a prospective observational study
The effect of preoperative administration of steroids in patients with superior vena cava syndrome who underwent rigid bronchoscopic intervention
Japan |
Superior vena cava syndrome
Medicine in general | Pneumology |
Malignancy
NO
To evaluate the preoperative steroid administration effects on the incidence of glottic edema and extubation failure in patients with superior vena cava syndrome who underwent rigid bronchoscopic intervention.
Safety,Efficacy
Exploratory
Not applicable
the incidence rate of glottic edema and extubation failure that occurred within 24 hours of rigid bronchoscopic intervention.
1. To evaluate the patient's symptoms (VAS scale)
2. To evaluate the relationship between the stridor and extubation failure
3. To evaluate the relationship between glottic edema, the external diameter of the rigid bronchoscope, and operation time
4. To evaluate the relationship between postoperative glottic edema and the type and external diameter of airway stents
5. To evaluate the relationship between the grade of superior vena cava syndrome, glottic edema, and extubation failure
6. To evaluate the relationship between type, dosage, and administration time of preoperative steroids and postoperative glottic edema
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1. Superior vena cava syndrome is classified as Grade 0 to 5. Grade 0 is asymptomatic (radiographic evidence of superior vena cava obstruction in the absence of signs and symptoms); Grade 1 is mild (edema of head or neck, cyanosis, plethora ); Grade 2 is moderate edema of head or neck with functional impairment accompanied by symptoms such as mild dysphagia, cough, temporomandibular joint disorder, or visual disturbances due to eyelid edema; Grade 3 is severe (mild or moderate cerebral edema (headache, dizziness) or mild to moderate laryngeal edema or diminished cardiac reserve (syncope after bending)); Grade 4 is life-threatening; substantial cerebral edema (confusion, obtundation) or substantial laryngeal edema (stridor) or substantial hemodynamic compromise (syncope without precipitating factors, hypotension, insufficiency); Grade 5 is fatal. In this study, patients with any grades are eligible.
2. The patients who previously received preoperative steroids underwent rigid bronchoscopic intervention. The patients who were already taking steroids were eligible, but they need to receive additional preoperative steroids.
3. The patients who will undergo tumor resection using a rigid bronchoscope under general anesthesia have planned assistance with electric snare, APC, cryoprobe or ballooning, airway stent placement, or removal of a foreign body.
4. Patients older than 20 years
5. Informed consent
1. The patients who have difficulty responding to the VAS before and after rigid bronchoscopic intervention
2. The patients who are not eligible as agreed by investigators
30
1st name | ATSUSHI |
Middle name | |
Last name | TORII |
National Hospital Organization Nagoya Medical Center
Department of respiratory medicine
460-0001
4-1-1 Sannomaru Naka-ku Nagoya Japan
0529511111
a51009068@gmail.com
1st name | ATSUSHI |
Middle name | |
Last name | TORII |
National Hospital Organization Nagoya Medical Center
Department of respiratory medicine
460-0001
4-1-1 Sannomaru Naka-ku Nagoya Japan
0529511111
a51009068@gmail.com
National Hospital Organization Nagoya Medical Center
Department of respiratory medicine
ATSUSHI TORII
National Hospital Organization Nagoya Medical Center
Department of respiratory medicine
Self funding
National Hospital Organization Okayama Medical Center
the Institutional Review Board of Nagoya Medical Center
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
0529511111
311-rec@mail.hosp.go.jp
NO
独立行政法人 国立病院機構 名古屋医療センター、独立行政法人 国立病院機構 岡山医療センター
2024 | Year | 03 | Month | 14 | Day |
Unpublished
Open public recruiting
2023 | Year | 12 | Month | 19 | Day |
2024 | Year | 02 | Month | 02 | Day |
2024 | Year | 03 | Month | 14 | Day |
2029 | Year | 04 | Month | 30 | Day |
Prospective consecutive study
2024 | Year | 03 | Month | 14 | Day |
2024 | Year | 03 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061465
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