Health Condition 1: J042- Acute laryngotracheitis
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.The Subjects who are eligible for the ALRINE Tracheal 2.T-tube insertion for laryngeal and tracheal stenosis are included in the study. Subjects with symptoms of breathlessness and stridor and laryngotracheal stenosis confirmed on CT scan are included in the study. 3. The Subjects must be willing and able to provide written Informed Consent by signing and dating the IRB or ECapproved Informed Consent form. If the Subject is not able to write on behalf of the Subject, the Subject`s Legally acceptable representative (LAR) can fill out the informed consent. When a Subject and LAR are illiterate, a literate impartial witness is required during consenting. 4. The Subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations
Exclusion criteria
Exclusion criteria: 1.The Subjects who are not willing to insert an ALRINE Tracheal T-tube are excluded from the study. 2.Cancer, or active malignant disease contributing to laryngotracheal stenosis is excluded from the study 3. Subjects having symptoms mimicking laryngotracheal stenosis but stenosis not found on CT scan or endoscopy are excluded from the study 4. Subjects having congenital tracheomalacia, laryngomalacia, vocal cord palsy, laryngeal clefts, congenital cysts, external compression of the airway due to mass lesions or vascular anomalies are excluded from the study 5. Subjects having infections/inflammation-croup, retropharyngeal abscess, tracheitis, neoplasms-subglottic haemangioma, and recurrent respiratory papillomatosis are excluded from the study. 6.External compression, foreign body. 7. A Subject who is unwilling or unsuitable for postoperative instructions. 8.The Subject who is unwilling or unable to sign the Informed Consent Document will be excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Airway Patency 2.Decannulation 3.Device successTimepoint: 1. Time frame: Pre-operative, postoperative, 1 month 15 days, 3 months 15 days, 6 months 15 days 2. Time frame: post-operative, 1 month 15 days, 3 months 15 days, 6 months 15 days 3. Time frame: Intra-operative | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Shortness of Breathing Score 2. St Georges Respiratory Questionnaire 3.Adverse events and serious adverse events 4.Ease of useTimepoint: Time frame: Intra operative, Post-operative, 1 month 15 days, 3 months 15 days, 6 months 15 days | — |
Countries
India
Contacts
Public ContactDr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd
Outcome results
None listed