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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07723430
Comparison of High-Flow Nasal Cannula and Tight Face Mask for Maintaining Oxygenation During Rapid Sequence Induction
Comparison of the Effectiveness of High-Flow Oxygen Cannula Versus Tight Face Mask in Maintaining Oxygenation During Rapid Sequence Induction
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Rapid sequence induction (RSI) is the preferred technique for securing the airway in patients at risk of aspiration. Despite standardized airway management protocols, hypoxemia during the apneic period remains one of the most frequent and clinically important complications of RSI. Oxygen desaturation may lead to serious adverse events including cardiac arrhythmias, hemodynamic instability, cardiac arrest, neurological injury, and increased mortality. Effective preoxygenation before induction is therefore essential to maximize oxygen reserves and prolong safe apnea time.
Conventional preoxygenation is commonly performed using a tight face mask delivering 100% oxygen. Although this method is widely accepted, oxygen delivery is interrupted when the face mask is removed for laryngoscopy, potentially reducing oxygen reserves during prolonged intubation attempts. High-Flow Nasal Cannula (HFNC) delivers heated and humidified oxygen at high flow rates with a high inspired oxygen fraction while allowing continuous oxygen administration throughout laryngoscopy and apnea. HFNC also generates low-level positive airway pressure and facilitates clearance of upper airway dead space, which may improve oxygenation during rapid sequence induction.
Previous randomized trials and systematic reviews have produced inconsistent findings regarding the comparative effectiveness of HFNC and conventional face mask preoxygenation. Some studies have demonstrated prolonged safe apnea time and improved oxygenation with HFNC, whereas others have shown similar oxygen saturation between both techniques. Additional randomized controlled trials are required to determine whether HFNC provides clinically meaningful advantages in adult patients undergoing rapid sequence induction.
This single-center, prospective, parallel-group, randomized controlled trial will be conducted at the Department of Anesthesiology, Khyber Teaching Hospital, Peshawar. Eligible adult patients requiring rapid sequence induction for endotracheal intubation in the operating room, emergency department, or intensive care unit will be enrolled after providing informed consent. Participants will be randomly assigned in a 1:1 ratio to receive either High-Flow Nasal Cannula or Tight Face Mask preoxygenation using a computer-generated randomization sequence with allocation concealment through sequentially numbered, opaque, sealed envelopes.
Patients allocated to the intervention group will receive heated, humidified oxygen via High-Flow Nasal Cannula at the protocol-defined flow rate and fraction of inspired oxygen before induction and throughout laryngoscopy until successful endotracheal intubation. Participants allocated to the control group will receive conventional preoxygenation using a tightly fitting face mask delivering 100% oxygen according to standard institutional practice until induction of anesthesia.
The primary outcome will be the lowest peripheral oxygen saturation (SpO₂) recorded from induction until successful tracheal intubation. Secondary outcome measures will include the incidence of oxygen desaturation below 90%, duration of apnea, duration of laryngoscopy, time required for successful intubation, first-pass intubation success, number of intubation attempts, and peri-intubation adverse events including hypotension, arrhythmias, aspiration, and cardiac arrest.
Data will be collected prospectively using standardized case report forms by trained investigators. Statistical analyses will follow the intention-to-treat principle. Continuous variables will be compared using the independent-samples t-test or Mann-Whitney U test as appropriate, whereas categorical variables will be compared using the Chi-square test or Fisher's exact test. A two-sided p-value of less than 0.05 will be considered statistically significant.
The results of this trial are expected to provide high-quality evidence regarding the optimal preoxygenation strategy during rapid sequence induction and may contribute to improved airway management protocols and reduction of peri-intubation hypoxemia in adult patients.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults aged 18 years or older.
- Patients requiring rapid sequence induction (RSI) for endotracheal intubation in the operating room, emergency department, or intensive care unit.
- Patients in whom both high-flow nasal cannula (HFNC) and tight face mask preoxygenation are technically feasible.
- Patients (or their legally authorized representatives, when applicable) able to provide written informed consent.
Exclusion Criteria:
- Patients requiring immediate crash intubation without sufficient time for preoxygenation.
- Patients with facial deformities, upper airway obstruction, or other conditions preventing the use of either HFNC or a tight face mask.
- Known contraindications or hypersensitivity to medications used for rapid sequence induction.
- Pregnant women.
- Patients younger than 18 years of age.
- Patients with do-not-intubate (DNI) orders.
- Patients already intubated or mechanically ventilated before enrollment.
- Patients who underwent endotracheal intubation within the previous 24 hours.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: High-Flow Nasal Cannula (HFNC)
Participants randomized to this arm will receive preoxygenation using a heated, humidified high-flow nasal cannula delivering oxygen at 60 L/min with an FiO₂ of 100% for 3 minutes before rapid sequence induction.
The HFNC will remain in place during induction and laryngoscopy until successful endotracheal intubation to provide continuous oxygenation throughout the apneic period.
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Participants assigned to this intervention will receive preoxygenation using a heated, humidified high-flow nasal cannula delivering oxygen at a flow rate of 60 L/min with an inspired oxygen fraction (FiO₂) of 1.0 (100%) for 3 minutes before rapid sequence induction.
Oxygen delivery will be continued throughout the apneic period and laryngoscopy until successful endotracheal intubation.
Otros nombres:
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Comparador activo: Tight Face Mask (TFM)
Participants randomized to this arm will receive standard preoxygenation using a tightly fitting anesthesia face mask delivering 100% oxygen at 15 L/min for 3 minutes before rapid sequence induction. The face mask will be removed immediately before laryngoscopy according to routine clinical practice. These arm titles and descriptions are appropriate for ClinicalTrials.gov registration. The next step will be to link each arm to its corresponding Device Intervention (HFNC and Tight Face Mask). |
Participants assigned to this intervention will receive standard preoxygenation using a tightly fitting anesthesia face mask delivering 100% oxygen at a flow rate of 15 L/min for 3 minutes before rapid sequence induction.
The face mask will be removed immediately before laryngoscopy in accordance with standard clinical practice.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Lowest Peripheral Oxygen Saturation (SpO₂) During Rapid Sequence Induction
Periodo de tiempo: Periprocedural (during rapid sequence induction, from induction of anesthesia until successful endotracheal intubation; approximately 5 minutes).
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Periprocedural (during rapid sequence induction, from induction of anesthesia until successful endotracheal intubation; approximately 5 minutes).
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Incidence of Oxygen Desaturation
Periodo de tiempo: Periprocedural (during rapid sequence induction, from induction of anesthesia until successful endotracheal intubation; approximately 5 minutes).
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Periprocedural (during rapid sequence induction, from induction of anesthesia until successful endotracheal intubation; approximately 5 minutes).
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 015/DME/KMC
Información sobre medicamentos y dispositivos, documentos del estudio
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