Emergency Airway ManagementNCT07591909
The Airway Pressures During Bag-Valve-Mask Ventilation
A study testing Two Handed CE Technique, Two Handed TE Technique and One Handed Technique in people with Emergency Airway Management and Gastric Inflation Risk During Bag-Valve-Mask Ventilation, run by Akdeniz University Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Emergency Airway Management, Gastric Inflation Risk During Bag-Valve-Mask Ventilation, Breathing Emergency
- What is being tested?
- Two Handed CE Technique, Two Handed TE Technique and One Handed Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2024to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 18 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Airway Pressures During Bag-Valve-Mask Ventilation: A Randomized Crossover Trial
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.
Read the detailed description
Introduction:
Emergency department (ED) patients are considered to have an elevated risk of gastric distention and aspiration of gastric contents, making rapid sequence induction (RSI) the preferred intubation procedure. Pre-oxygenation is likely the most critical step in RSI, as it extends the duration of safe apnea time, providing the operator with more time for the intubation process. Although a facemask with a high FiO2 oxygen reservoir is recommended for pre-oxygenation, bag-valve-mask (BVM) ventilation is frequently used in emergency airway management.
Since its development during the polio epidemic in 1953, the BVM has been used for oxygenation and ventilation of critically ill patients. However, the positive pressure generated by the BVM can increase the risk of regurgitation and aspiration of gastric contents into the lungs. Excessive volumes and flow generated with the BVM can not only lead to gastric distention but also increase intrathoracic pressures, potentially causing negative cardiovascular effects.
The aim of this randomized crossover manikin study is to investigate how airway pressures change during ventilation with a BVM using different scenarios and techniques.
Methods:
This is a randomized crossover trial performed in the simulation lab of a tertiary care facility between 15.07.2024 to 15.08.2024. The ethical committee of XXX approved the study and informed consent was obtained from the participants. The participants were emergency medicine residents ranging from postgraduate year 1 (PGY) to PGY4.
In this study, airway pressures during BVM ventilation were continuously recorded using a calibrated pressure sensor placed between the facemask and the bag. All participants were requested to ventilate the Resusci Anne QCPR airway mannequin (Laerdal Medical, Stavanger, Norway) in a randomized manner using one-hand, two-hand (CE method), and modified two-hand (TE method) techniques, while the airway pressures were measured. Two different scenarios were applied to simulate normal and difficult airways while ventilating the airway mannequin. For the difficult airway scenario, a cervical collar was applied to the airway mannequin. To reduce potential bias, the purpose of the study was not explained to the participants Each participant was asked to provide a sufficient amount of air with the BVM to raise the mannequin's chest and to repeat these 10 times in a randomized order. All the pressure values measured during ventilation were recorded as cmH2O. The highest-pressure value measured during ventilations, as well as the number of ventilations during which the pressure exceeded 20 cmH2O, were recorded.
The differences in the pressure values measured using different hand techniques in normal and difficult airway scenarios were evaluated. Additionally, it was assessed which scenario and technique resulted in pressures exceeding 20 cmH2O, based on the theoretical assumption that pressures above this value would open the lower esophageal sphincter and inflate the stomach with air. This assumption was based on previous studies indicating that lower esophageal sphincter pressure is typically exceeded, and gastric inflation begins, when airway pressure surpasses 20 cmH₂O.
Statistical analysis:
The study data were analyzed using the SPSS software version 16.0 for Windows (SPSS Inc., Chicago, IL, USA). Demographic and baseline characteristics were summarized as a mean ± standard deviation for continuous variables and as a percentage of the group for categorical variables. Non-normally distributed data are presented as medians (interquartile range). For each scenario and technique, the participant was considered the unit of analysis. For every participant, the highest pressure value among the 10 ventilations and whether ≥5 of 10 ventilations exceeded 20 cmH2O were used in the analyses The chi-square test was used to compare the ventilations exceeding the 20 cmH2O pressure value with PGY levels. P < 0.05 was accepted as statistically significant.
- Conditions
- Emergency Airway Management, Gastric Inflation Risk During Bag-Valve-Mask Ventilation, Breathing Emergency
- Being tested
- Two Handed CE Technique, Two Handed TE Technique, One Handed Technique
- Keywords
- Bag-valve mask, lower esophageal sphincter, gastric insufflation, Hand-grip techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two Handed CE TechniqueOther
Describes the CE hand-holding position during the balloon mask ventilation.
Two Handed TE TechniqueOther
Describes the TE hand-holding position during the balloon mask ventilation.
One Handed TechniqueOther
Describes the One hand-holding position during the balloon mask ventilation.
| Study group | Role | What they receive |
|---|---|---|
| PGY juniors (under 2 yrs) | Other | Residents who have been working as assistants for less than two years Receives: 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. Receives: Other: Two Handed CE Technique; Other: Two Handed TE Technique; Other: One Handed Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the ventilation procedure (a continuous 10-breath sequence per technique/scenario
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start15 Jul 2024
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergency Airway ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erkan Göksu, Akdeniz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591909
- Sponsor's protocol ID
- AkdenizUH
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized data can be shared if deemed appropriate when requested.
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Airway Pressures During Bag-Valve-Mask Ventilation: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT07591909
- Acronym / sponsor ID
- AkdenizUH
- Conditions
- Emergency Airway Management, Gastric Inflation Risk During Bag-Valve-Mask Ventilation, Breathing Emergency
- Keywords
- Bag-valve mask, lower esophageal sphincter, gastric insufflation, Hand-grip techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Akdeniz University HospitalUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction:
Emergency department (ED) patients are considered to have an elevated risk of gastric distention and aspiration of gastric contents, making rapid sequence induction (RSI) the preferred intubation procedure. Pre-oxygenation is likely the most critical step in RSI, as it extends the duration of safe apnea time, providing the operator with more time for the intubation process. Although a facemask with a high FiO2 oxygen reservoir is recommended for pre-oxygenation, bag-valve-mask (BVM) ventilation is frequently used in emergency airway management.
Since its development during the polio epidemic in 1953, the BVM has been used for oxygenation and ventilation of critically ill patients. However, the positive pressure generated by the BVM can increase the risk of regurgitation and aspiration of gastric contents into the lungs. Excessive volumes and flow generated with the BVM can not only lead to gastric distention but also increase intrathoracic pressures, potentially causing negative cardiovascular effects.
The aim of this randomized crossover manikin study is to investigate how airway pressures change during ventilation with a BVM using different scenarios and techniques.
Methods:
This is a randomized crossover trial performed in the simulation lab of a tertiary care facility between 15.07.2024 to 15.08.2024. The ethical committee of XXX approved the study and informed consent was obtained from the participants. The participants were emergency medicine residents ranging from postgraduate year 1 (PGY) to PGY4.
In this study, airway pressures during BVM ventilation were continuously recorded using a calibrated pressure sensor placed between the facemask and the bag. All participants were requested to ventilate the Resusci Anne QCPR airway mannequin (Laerdal Medical, Stavanger, Norway) in a randomized manner using one-hand, two-hand (CE method), and modified two-hand (TE method) techniques, while the airway pressures were measured. Two different scenarios were applied to simulate normal and difficult airways while ventilating the airway mannequin. For the difficult airway scenario, a cervical collar was applied to the airway mannequin. To reduce potential bias, the purpose of the study was not explained to the participants Each participant was asked to provide a sufficient amount of air with the BVM to raise the mannequin's chest and to repeat these 10 times in a randomized order. All the pressure values measured during ventilation were recorded as cmH2O. The highest-pressure value measured during ventilations, as well as the number of ventilations during which the pressure exceeded 20 cmH2O, were recorded.
The differences in the pressure values measured using different hand techniques in normal and difficult airway scenarios were evaluated. Additionally, it was assessed which scenario and technique resulted in pressures exceeding 20 cmH2O, based on the theoretical assumption that pressures above this value would open the lower esophageal sphincter and inflate the stomach with air. This assumption was based on previous studies indicating that lower esophageal sphincter pressure is typically exceeded, and gastric inflation begins, when airway pressure surpasses 20 cmH₂O.
Statistical analysis:
The study data were analyzed using the SPSS software version 16.0 for Windows (SPSS Inc., Chicago, IL, USA). Demographic and baseline characteristics were summarized as a mean ± standard deviation for continuous variables and as a percentage of the group for categorical variables. Non-normally distributed data are presented as medians (interquartile range). For each scenario and technique, the participant was considered the unit of analysis. For every participant, the highest pressure value among the 10 ventilations and whether ≥5 of 10 ventilations exceeded 20 cmH2O were used in the analyses The chi-square test was used to compare the ventilations exceeding the 20 cmH2O pressure value with PGY levels. P < 0.05 was accepted as statistically significant.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PGY juniors (under 2 yrs) | Other | Other: Two Handed CE Technique, Other: Two Handed TE Technique, Other: One Handed TechniqueResidents who have been working as assistants for less than two years |
| PGY Senior ( above 2 years) | Other | Other: Two Handed CE Technique, Other: Two Handed TE Technique, Other: One Handed TechniqueResidents who have been working as assistants for more than two years. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 18 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two Handed CE TechniqueDescribes the CE hand-holding position during the balloon mask ventilation. | Other | PGY Senior ( above 2 years), PGY juniors (under 2 yrs) |
| Two Handed TE TechniqueDescribes the TE hand-holding position during the balloon mask ventilation. | Other | PGY Senior ( above 2 years), PGY juniors (under 2 yrs) |
| One Handed TechniqueDescribes the One hand-holding position during the balloon mask ventilation. | Other | PGY Senior ( above 2 years), PGY juniors (under 2 yrs) |
Primary outcome
Incidence of airway pressure exceeding 20 cmH2O
Time frame: During the ventilation procedure (a continuous 10-breath sequence per technique/scenario
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Results publication1- 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.
- Individual participant dataSharing planned: No. Anonymized data can be shared if deemed appropriate when requested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two Handed CE Technique, Two Handed TE Technique and One Handed Technique in people with Emergency Airway Management and Gastric Inflation Risk During Bag-Valve-Mask Ventilation, run by Akdeniz University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of airway pressure exceeding 20 cmH2O (time frame: During the ventilation procedure (a continuous 10-breath sequence per technique/scenario). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07591909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.