The Airway Pressures During Bag-Valve-Mask Ventilation

NCT07591909 | Completed

• 1 other identifier: AkdenizUH
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Objective Bag-valve-mask (BVM) ventilation is commonly used in emergency airway management, but the positive pressure generated may increase aspiration risk. This prospective, randomized, simulation-based manikin study aimed to assess how airway pressures change during BVM ventilation using different techniques and neck mobility scenarios. Methods The study was conducted in a tertiary university hospital between July 15 and August 15, 2024. Emergency medicine residents (PGY-1 to PGY-4) performed ten ventilations using one-hand, two-hand CE, and modified two-hand TE techniques on a manikin under normal and restricted neck mobility. Airway pressures were measured with a real-time pressure sensor. The primary outcome was peak airway pressure; the secondary was the number of ventilations exceeding 20 cmH₂O. All data were automatically recorded, and analyses were performed using SPSS 16.0 with p \< 0.05 considered significant.

Conditions

Emergency Airway Management; Breathing Emergency; Gastric Inflation Risk During Bag-Valve-Mask Ventilation

Keywords

Bag-valve mask; lower esophageal sphincter; gastric insufflation; Hand-grip techniques

Outcome Measures

Primary Outcomes (1)

• Incidence of airway pressure exceeding 20 cmH2O

  The frequency of breaths delivered with a peak airway pressure greater than 20 cmH2O (the threshold for gastric inflation risk) during Bag-Valve-Mask (BVM) ventilation.

  During the ventilation procedure (a continuous 10-breath sequence per technique/scenario

Study Arms (2)

PGY juniors (under 2 yrs)

OTHER

Residents who have been working as assistants for less than two years

Other: Two Handed CE Technique; Other: Two Handed TE Technique; Other: One Handed Technique

PGY Senior ( above 2 years)

OTHER

Residents who have been working as assistants for more than two years.

Other: Two Handed CE Technique; Other: Two Handed TE Technique; Other: One Handed Technique

Interventions

Two Handed CE Technique OTHER

Describes the CE hand-holding position during the balloon mask ventilation.

PGY Senior ( above 2 years); PGY juniors (under 2 yrs)

Two Handed TE Technique OTHER

Describes the TE hand-holding position during the balloon mask ventilation.

PGY Senior ( above 2 years); PGY juniors (under 2 yrs)

One Handed Technique OTHER

Describes the One hand-holding position during the balloon mask ventilation.

PGY Senior ( above 2 years); PGY juniors (under 2 yrs)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older.
• Medical residents (Post-graduate years 1-4) or practicing emergency medicine physicians.
• Ability and willingness to provide informed consent to participate in the simulation.
• Experience with basic airway management and BVM ventilation in a clinical setting.

You may not qualify if:

• Lack of Experience:
• Any musculoskeletal or neurological condition that would prevent the participant from performing manual BVM maneuvers effectively.
• Refusal to Participate: Inability to provide informed consent.

Sponsors & Collaborators

• Akdeniz University Hospital: lead

Study Sites (1)

Akdeniz University Hospital

Antalya, 07059, Turkey (Türkiye)

Location

Related Publications (1)

• 1- Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. 2- Lee CP, Yip YY. Understanding your bag-valve-mask resuscitator. BJA Educ. 2023 Jun;23(6):208-211. doi: 10.1016/j.bjae.2023.03.003. 3- Lawes EG, Campbell I, Mercer D. Inflation pressure, gastric insufflation, and rapid sequence induction. Br J Anaesth. 1987 Mar;59(3):315-8. doi: 10.1093/bja/59.3.315. 4- Bowman FP, Menegazzi JJ, Check BD, Duckett TM. Lower esophageal sphincter pressure during prolonged cardiac arrest and resuscitation. Ann Emerg Med. 1995 Aug;26(2):216-9. doi: 10.1016/s0196-0644(95)70154-0. 5- von Goedecke A, Wagner-Berger HG, Stadlbauer KH, Krismer AC, Jakubaszko J, Bratschke C, Wenzel V, Keller C. Effects of decreasing peak flow rate on stomach inflation during bag-valve-mask ventilation. Resuscitation. 2004 Nov;63(2):131-6. doi: 10.1016/j.resuscitation.2004.04.012.

  RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 18, 2026
• Study Start: July 15, 2024
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)