Comparison of High-Flow Nasal Cannula and Tight Face Mask for Maintaining Oxygenation During Rapid Sequence Induction

NCT07723430 | Not Yet Recruiting

• 1 other identifier: 015/DME/KMC
• Study Type: interventional
• Target: 290
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypoxemia; Airway Management; Endotracheal Intubation; Rapid Sequence Induction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of Oxygen Desaturation

  Periprocedural (during rapid sequence induction, from induction of anesthesia until successful endotracheal intubation; approximately 5 minutes).

Study Arms (2)

High-Flow Nasal Cannula (HFNC)

EXPERIMENTAL

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

Tight Face Mask (TFM)

ACTIVE COMPARATOR

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

Interventions

High-Flow Nasal Cannula DEVICE

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.

Also known as: High-Flow Nasal Oxygen (HFNO)

High-Flow Nasal Cannula (HFNC)

Tight Face Mask DEVICE

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.

Tight Face Mask (TFM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khyber Teaching Hospital: lead

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Resident

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention groups. One group will receive preoxygenation using High-Flow Nasal Cannula (HFNC), while the other group will receive preoxygenation using a Tight Face Mask (TFM) before rapid sequence induction. Participants will receive only the assigned intervention, and outcomes will be compared between the two groups.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 23, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): February 20, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07