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NCT07204990: BELUGA
BELUGA: Better to Exchange ETT for LMA Before Extubation in Children Under General Anaesthesia
NA trial testing Endotracheal tube removed awake in Endotracheal Extubation in 1,400 participants. Not yet recruiting.
12 January 2029
Quick facts
| Lead sponsor | Telethon Kids Institute |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 1,400 |
| Start date | 12 January 2026 |
| Primary completion | 12 January 2029 |
| Estimated completion | 30 January 2029 |
| Sites | 8 locations across Italy, Sweden, Switzerland, Australia, United States, Brazil |
Drugs / interventions tested
- Endotracheal tube removed awake
- Laryngeal mask airway inserted following deep extubation
Conditions studied
- Endotracheal Extubation — all drugs for Endotracheal Extubation →
- Airway Anesthesia — all drugs for Airway Anesthesia →
- Paediatric — all drugs for Paediatric →
Sponsor
Telethon Kids Institute
Who can join
Adults 0 to 16, any sex, with Endotracheal Extubation or Airway Anesthesia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
During surgery, anaesthetists can use an endotracheal tube (ETT) to facilitate ventilation. At emergence from general anaesthesia, there are two techniques for removal of the ETT: (1) the ETT is removed when the child is waking up in (awake removal); or (2) the ETT is removed while still under anaesthesia(deep removal). Currently there is no evidence to suggest either technique is safer - deep removal of the ETT may decrease the risk of overall airway complications, including cough and desaturations. However, it may be associated with increased airway obstruction compared with awake extubation in paediatric patients. In our institution, a further technique has become increasingly common practice: removing ETT deep to avoid coughing and desaturation, then inserting a laryngeal mask airway (LMA) which can be removed once the patient is awake in the postoperative care unit (PACU), avoiding the risk of airway obstruction coupled with deep airway removal. The aim of the study is to assess whether deep removal of an ETT and exchange to an LMA, is superior to awake ETT removal with regards to the occurrence of postoperative respiratory adverse events. In this study, patients will be randomised to awake removal of ETT or deep removal of an ETT and exchange to an LMA. Data will be collected regarding the rate of respiratory adverse events in either group, as well as the incidence of post-operative pain, delirium and nausea and vomiting.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07204990
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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 NCT07204990 (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 Telethon Kids Institute
- Last refreshed: 1 December 2025
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/NCT07204990.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing