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NCT04268043
Comparation of Proseal Laryngeal Mask Airway With Flexible Laryngeal Airway Mask
NA trial testing flexible laryngeal airway mask in Anesthesia Intubation Complication in 200 participants. Status unknown.
1 June 2023
Quick facts
| Lead sponsor | Eye & ENT Hospital of Fudan University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 200 |
| Start date | 1 October 2021 |
| Primary completion | 1 June 2023 |
| Estimated completion | 1 December 2023 |
Drugs / interventions tested
- flexible laryngeal airway mask
- proseal laryngeal mask airway
Conditions studied
- Anesthesia Intubation Complication — all drugs for Anesthesia Intubation Complication →
Sponsor
Eye & ENT Hospital of Fudan University
Who can join
Adults 18 to 65, any sex, with Anesthesia Intubation Complication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Objective To investigate the comparative effect of proseal laryngeal mask airway and flexible laryngeal airway mask during otitis media surgery. Methods 200 patients of ASA I or II classification, 18-65 years old, BMI\<30 kg/m2 undergoing otitis media surgery are randomly divided into two groups (Group P with proseal laryngeal mask airway and Group F with flexible laryngeal airway mask, respectively). After induction, selecting a appropriate size of LMA to patient,s weight, using the standard index finger-guided technique inserting the LMA, and then the patients were ventilated mechanically. The success rate of inserting laryngeal mask, the intubation time, surgery time and wake time were also recorded. Tidal volume and leakage pressure in patients with supine and lateral positioning were assessed respectively. The scale of fiberoptic bronchoscopy was also recorded to show airway exposure. Related complications such as sore throat, hoarseness, cough, laryngospasm, bloating, nausea and vomiting, soft tissue injury, blood residue after pulling out the LMA were analyzed.Postoperative voice and laryngopharyngeal symptom are also recorded.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04268043
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Related trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04268043 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eye & ENT Hospital of Fudan University
- Last refreshed: 19 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04268043.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing