- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05143346
A Comparison Between Using Video Stylet and Video Laryngoscope in Difficult Intubation of Traumatic Patients .
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The airway, breathing and circulation support '' ABCs" of trauma resuscitation were born from the assumption that correcting hypoxemia and hypotension reduces morbidity and mortality. Definitive care for severely injured or polytrauma patients includes the ability to provide advanced airway management in a variety of settings: in the emergency department, 20% to 30% intubations are for trauma. Airway management in traumatic patient presents numerous unique challenges beyond placement of an endotracheal tube, without comes dependent on the provider's ability to predict and anticipate difficulty and have a safe and executable plan. In severely injured patients, the cervical spine must be protected by in-line immobilisation during airway management. If orotracheal intubation is required, then manual in-line stabilisation is recommended to facilitate tracheal intubation to secure a space for tongue displacement into the submandibular space. However, manual in-line stabilisation can make alignment of the oral, pharyngeal and laryngeal axes difficult, resulting in a poor direct laryngoscopic view and prolonging the intubation time. Video stylets, which are portable and easier to prepare than flexible fiberoptic bronchoscopes, could be better option for tracheal intubation in patient with cervical immobilization. Previous studies have shown the usefulness of video stylets for tracheal intubation in cervical immobilized patients.
Video laryngoscopes provide a better laryngeal view. They are easy to use and have a high success rate and short intubation time in patients with predicted difficult airways. Successful use of video laryngoscopy is increasing for airway management of patients with trauma in the emergency department.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Wesam Mahran
- Numero di telefono: +201028181966
- Email: wesammahran39@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Any patient in the age group of (5 - 80) and has
- Suspected difficult intubation.
- High mallampati score (class 111, 1V).
- Suspected cervical fracture.
- Maxillofacial trauma.
- Fracture base of the skull.
- Polytrauma.
Exclusion Criteria:
- Patients with low mallampati score (class 1, 11).
- Patients undergoing elective surgeries and not suspected to have difficult intubations.
- Patients aged below 5 years and above 80 years.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Altro: Group A
Group A will include 168 patients and will be intubated by the use of video stylet.
|
Using video stylet and video laryngoscope in difficult intubation in patients with trauma or suspected to be have difficult intubation.
|
Altro: Group B
Group B will include 168 patients and will intubated by the use of video laryngoscope
|
Using video stylet and video laryngoscope in difficult intubation in patients with trauma or suspected to be have difficult intubation.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Comparison of success rate for the tracheal intubation in patients with anticipated difficult airways, demonstrating the non inferiority of video stylet efficacy compare to the most consolidated technique based on videolaryngoscope
Lasso di tempo: 9 minutes
|
The success rate of the rigid fiberoptic stylet to perform tracheal intubation in patients with anticipated difficult airways [ Time Frame: up to a maximum of 3 attempts and up to 3 minutes from device insertion for each attempt (max 9 minutes) ] . success rate of the procedure defined as correct positioning of the tracheal tube in the trachea confirmed both endoscopically and through the capnographic curve end tidal carbon dioxide (Et CO2) time consumed to achieve a successful intubation by each device. |
9 minutes
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Average time of intubation procedure expressed in seconds [ Time Frame: up to 9 minutes ]
Lasso di tempo: 9 minutes
|
Time in minutes measured from device insertion into the patient's mouth until the endotracheal tube will be positioned into the trachea . |
9 minutes
|
Development of any complications [ Time Frame: up to 12 hours measured from the insertion of the device ]
Lasso di tempo: 12 hours
|
Occurrence of any complications or adverse event during the procedure (desaturation episodes, hemodynamic changes, oral-pharynx and larynx traumatism)
|
12 hours
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- Tosone SR, Reves JG, Kissin I, Smith LR, Fournier SE. Hemodynamic responses to nifedipine in dogs anesthetized with halothane. Anesth Analg. 1983 Oct;62(10):903-8.
- Hayat K, Finnegan M, Lee KA, Rees RC, Hancock BW, Goyns MH. Variable expression of the interleukin-2 receptor alpha chain and MYC genes in lymphocytes from renal cell carcinoma patients treated with interleukin-2. Cancer Lett. 1992 Aug 14;65(2):173-8. doi: 10.1016/0304-3835(92)90163-p.
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Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- Difficult intubation
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Intubation
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The University of Texas Health Science Center,...KARL STORZ Endoscopy-America, Inc.CompletatoIntubazione, endotrachealeStati Uniti