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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Endotracheal Intubation; Airway Management; Hypoxemia; Rapid Sequence Induction
• Intervention / Treatment: Device: High-Flow Nasal Cannula; Device: Tight Face Mask

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 290
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: High-Flow Nasal Cannula; 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.; Other Names: High-Flow Nasal Oxygen (HFNO)
Active Comparator: 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).	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lowest Peripheral Oxygen Saturation (SpO₂) During Rapid Sequence Induction	Periprocedural (during rapid sequence induction, from induction of anesthesia until successful endotracheal intubation; approximately 5 minutes).

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of Oxygen Desaturation	Periprocedural (during rapid sequence induction, from induction of anesthesia until successful endotracheal intubation; approximately 5 minutes).

Collaborators and Investigators

• Sponsor: Khyber Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): February 20, 2027

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia
• Other Study ID Numbers: 015/DME/KMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No