Comparison of the Effectiveness of High-Flow Oxygen Cannula Versus Tight Face Mask in Maintaining Oxygenation During Rapid Sequence Induction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 290
- 主要终点
- Lowest Peripheral Oxygen Saturation (SpO₂) During Rapid Sequence Induction
研究概览
简要总结
This prospective randomized controlled trial aims to compare the effectiveness of High-Flow Nasal Cannula (HFNC) versus Tight Face Mask (TFM) in maintaining oxygenation during rapid sequence induction (RSI) for endotracheal intubation in adult patients. Participants will be randomly assigned in a 1:1 ratio to receive either HFNC or TFM for preoxygenation before induction of anesthesia. The primary outcome is the lowest peripheral oxygen saturation (SpO₂) recorded from induction until successful endotracheal intubation. Secondary outcomes include the incidence of oxygen desaturation (<90%), duration of apnea, duration of laryngoscopy, intubation time, number of intubation attempts, and peri-intubation complications. The study will determine whether HFNC provides superior oxygenation compared with conventional face mask preoxygenation during RSI and may contribute to improving airway management protocols and patient safety.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label trial because the oxygen delivery devices are visibly different, making blinding of participants and healthcare providers impractical. Outcome variables, including peripheral oxygen saturation (SpO₂), are objectively measured using standard pulse oximetry, minimizing measurement bias.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Lowest Peripheral Oxygen Saturation (SpO₂) During Rapid Sequence Induction
时间窗: Periprocedural (during rapid sequence induction, from induction of anesthesia until successful endotracheal intubation; approximately 5 minutes).
次要结局
- Incidence of Oxygen Desaturation(Periprocedural (during rapid sequence induction, from induction of anesthesia until successful endotracheal intubation; approximately 5 minutes).)
研究者
Shandana Gul
Post Graduate Resident
Khyber Teaching Hospital