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Effect of Head and Neck Positioning on Awake Fiberoptic Intubation in Obese Patients

4 novembre 2026 aggiornato da: Amr Raafat Mahmoud Seif, Cairo University

Effect of Head and Neck Positioning on Awake Fiberoptic Intubation in Obese Patients: A Randomized Controlled Study

The aim of the study was the assessment and comparison of the time taken for vocal cord visualization with three different head positions: (conventional sniffing position, ramp position and supine position) in obese patients

Panoramica dello studio

Descrizione dettagliata

Airway management in patients undergoing general anesthesia is a set of actions that result in the creation of a safe and secure airway for ventilation. Failure in airway management and hypoxia can lead to irreversible brain damages within only a few minutes .

The prevalence of obesity is rising worldwide, and this is a challenge for specialists in various fields of medicine. There is an inverse correlation between body weight and pharyngeal space. This association is significant because excess fat in morbid obesity can influence the pharyngeal spaces, and thus, significantly change laryngoscopic grade . Overall, airway management in obese patients can pose numerous challenges as these patients are at a higher risk for difficult airway than normal patients . In fact, patients with morbid obesity have excess fat in the mouth, neck, pharynx, thorax, breast, and abdomen, making access to the airway more problematic in various anesthesia situations such as intubation, tracheostomy, or mask ventilation as compared to normal subjects. In most studies, an increase in neck circumference was associated with difficult intubation, and a neck circumference over 60 cm was linked with a 35% likelihood of difficult intubation. Hence, the possibility of difficult intubation and problems with difficult airways in these patients should be considered, and a solution should be provided. In dealing with difficult airways, assistive devices such as fiberoptic bronchoscope and video-laryngoscope may be used in either awake or anesthetized patients .

Proper positioning before the induction of anesthesia is a key step in successful intubation . Numerous studies have emphasized the significance of head and neck positioning, which can have a significant impact on successful intubation and reduce tracheal injury and post-intubation complications .

The aim of the study was the assessment and comparison of the time taken for vocal cord visualization with three different head positions: (conventional sniffing position, ramp position and supine position) in obese patients

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Cairo, Egitto
        • Cairo University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 60 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Age between 18 to 60 years old
  • Body mass index more than 40 kg/m
  • Potentially difficult intubation defined as mallampatti classification greater than two and neck circumference more than 40 cm

Exclusion Criteria:

  • Age younger than 18 and more than 60 years old
  • American Society of Anesthesiologists clinical status is more than four
  • Sever mental disorder (psychotic or consider incapable of understanding the information)
  • Mouth opening is less than 15 mm
  • Poor dental status
  • Contraindication to any drug used in the study
  • patient refusal.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Group (S) Sniffing position

Group (S) Sniffing position : All patients will be explained the procedure on the day of surgery. Intravenous access will be gained a 16 through gauge cannula under local anesthesia. Standard monitoring (pulse oximeter, electrocardiography, non-invasive blood pressure) will attach to the patients. The patient's airway will be anesthetized using aerosolized lignocaine 2%.

The oral and pharyngeal reflexes will be blunted by anesthetizing oral and pharyngeal mucosa with 10% lignocaine spray and gargles.

Group (S) : patients will be explained the procedure on the day of surgery. Intravenous access will be gained a 16 through gauge cannula under local anesthesia. Standard monitoring (pulse oximeter, electrocardiography, non-invasive blood pressure) will attach to the patients. The patient's airway will be anesthetized using aerosolized lignocaine 2%.

The oral and pharyngeal reflexes will be blunted by anesthetizing oral and pharyngeal mucosa with 10% lignocaine spray and gargles. The sniffing position will be made by placing 8 cm ring pillow under the patient head so that it will be tilted. The external auditory meatus will be aligned the sterna notch in the horizontal plane. The elevation of the operating and position of the anesthesiologist will be adjusted to ensure that the fiber-optic will be kept straight as it entered the patient's nasal cavity. The appropriate-sized endotracheal tube will be loaded over a 5mm external diameter flexible fiberoptic bronchoscope. Preoxygenation w

Sperimentale: Group (R) Ramped position

Group (R) Ramped position: patients will be explained the process. Intravenous access will be gained and standard monitoring will be attached to the patients. The patient's airway will be anesthetized. After this, the patients will be helped to assume a ramped position. Three soft pillows will be positioned beneath the patient's head and upper body so that the external auditory meatus will be in a horizontal plane with a sternal notch.

Group (R) Ramped position On the day of the operation, all Group R patients will be explained the process. Intravenous access will be gained and standard monitoring will be attached to the patients. The patient's airway will be anesthetized. After this, the patients will be helped to assume a ramped position. Three soft pillows will be positioned beneath the patient's head and upper body so that the external auditory meatus will be in a horizontal plane with a sternal notch. The elevation of the operating and position of the anesthesiologist will be adjusted to ensure that the fiber-optic was straight as it entered the patient's nasal cavity. An appropriately sized endotracheal tube will be loaded over a 5mm external diameter flexible fiberoptic bronchoscope. Preoxygenation will be performed with 100% oxygen with tidal volume ventilation for three to five minutes to achieve an end-expiratory oxygen concentration greater than 90%.

Sperimentale: Group (SU) Supine position

Group (SU) Supine position: All Group SU patients were explained the procedure on the day of surgery. Intravenous access was gained through a 16-gauge cannula under local anesthesia. Standard monitoring (pulse oximeter, electrocardiography, non-invasive blood pressure) was attached to the patients. The patient's airway was anesthetized using aerosolized lignocaine 2%. The oral and pharyngeal reflexes were blunted by anesthetizing oral and pharyngeal mucosa with 10% lignocaine spray and gargles.

Group (SU) Supine position: patients were explained the procedure on the day of surgery. Intravenous access was gained through a 16-gauge cannula under local anesthesia. Standard monitoring (pulse oximeter, electrocardiography, non-invasive blood pressure) was attached to the patients. The patient's airway was anesthetized using aerosolized lignocaine 2%. The oral and pharyngeal reflexes were blunted by anesthetizing oral and pharyngeal mucosa with 10% lignocaine spray and gargles. The elevation of the operating and position of the anesthesiologist will be adjusted to ensure that the fiber-optic was kept straight as it entered the patient's nasal cavity. The appropriate-sized endotracheal tube will be loaded over a 5mm external diameter flexible fiberoptic bronchoscope. Preoxygenation will be performed with 100% oxygen with tidal volume ventilation for three to five minutes to achieve an end- expiratory oxygen concentration greater than 90%.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
comparison of the time taken for vocal cord visualization
Lasso di tempo: 1 hour

Assessment and comparison of the time taken for vocal cord visualization with three different head positions: (conventional sniffing position, ramp position and supine position) in obese patients.

1 hour

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cough score for fiberoptic and for intubation
Lasso di tempo: 1 hour

Cough score for fiberoptic and for intubation (score range: 0 = none, 1 = slight, 2 = moderate, 3 = severe)

1 hour

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 settembre 2026

Completamento primario (Stimato)

30 settembre 2027

Completamento dello studio (Stimato)

30 settembre 2027

Date di iscrizione allo studio

Primo inviato

4 novembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 novembre 2026

Primo Inserito (Effettivo)

10 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 novembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

It will be available if it needed

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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 .

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