PreoxygenationNCT07049666
Preoxygenation and Hemodynamics With Bag-valve-mask and Noninvasive Mechanical Ventilation
A study testing Bag-valve mask and Noninvasive mechanical ventilation in people with Preoxygenation, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Hypoxemia refers to low blood oxygen levels, while hypoxia denotes low tissue oxygen levels. Both conditions pose life-threatening risks when precautions are not adequately taken or when risks are not effectively managed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preoxygenation
- What is being tested?
- Bag-valve mask and Noninvasive mechanical ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Dec 2022to 1 Jun 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged over 18 years
- Having a partial arterial oxygen pressure (PaO2)/fraction of inspired oxygen (FiO2) ratio exceeding 200
- Consented to participate
Who cannot join
- Patients with an American Society of Anesthesiologists (ASA) Physical Status Classification System Score 4
- Patients with a Mallampati Score greater than 3
- Patients with a history of difficult intubation
- Patients who are pregnancy
- Patients who have hypoxia (defined as a PaO2/FiO2 ratio less than 200)
- Patients with heart failure
- Patients with chronic obstructive pulmonary disease
- Patients who undergoing emergency surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Preoxygenation With Bag-valve-mask and Noninvasive Mechanical Ventilation on Oxygenation and Hemodynamics: A Randomized Controlled Study
Hypoxemia refers to low blood oxygen levels, while hypoxia denotes low tissue oxygen levels. Both conditions pose life-threatening risks when precautions are not adequately taken or when risks are not effectively managed. Intubation represents a critical phase that can lead to a decrease in arterial oxyhemoglobin levels. Two frequently employed techniques for preoxygenation and ventilation during intubation are bag-valve mask (BVM) ventilation and noninvasive mechanical ventilation (NIMV). The aim of this study was to evaluate the efficacy and safety of BMV and the NIMV.
Read the detailed description
Ventilation and intubation challenges increase the risk of arterial desaturation, emphasizing the importance of careful management during this process. Throughout the intubation process, the oxygen reserves within the lung, plasma, hemoglobin, body mass index (BMI) play a critical role in meeting the tissue oxygen demand. Preoxygenation serves to extend the time window for intubation safely. The quantity of available oxygen reserve and the duration of the apneic period represent the primary determinants for the occurrence of hypoxemia during intubation.
Anticipating difficult intubation is crucial, as it often prolongs both the duration of intubation and the apneic period. The Intubation Difficulty Scale (IDS) is commonly utilized to predict the likelihood of encountering difficult intubation scenarios. It is imperative to select the appropriate preoxygenation technique, particularly in patients with a high IDS, to mitigate the risk of desaturation during the intubation process.
Two frequently employed techniques for preoxygenation and ventilation during intubation are BVM ventilation and NIMV. Preoxygenation, also referred to as denitrogenation, has the potential to induce atelectasis. However, this complication can be mitigated with positive pressure ventilation (PPV), which not only aids in maintaining oxygen levels but also exerts effects on the circulatory system. Hypotension is the most common symptom that occurs as a result of the interaction of the respiratory and circulatory systems.
The objective of this study was to evaluate and compare the impacts of preoxygenation with BVM and NIMV techniques on oxygenation and hemodynamic parameters specifically during the apneic period of endotracheal intubation.
- Conditions
- Preoxygenation
- Being tested
- Bag-valve mask, Noninvasive mechanical ventilation
- Keywords
- Preoxygenation, bag-valve-mask, noninvasive mechanical ventilation, hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bag-valve maskDevice
A BVM equipped with an oxygen reservoir, coupled with a correctly fitted oronasal mask was used.
Noninvasive mechanical ventilationDevice
Preoxygenation was conducted over a three-minute period using NIMV employing a properly fitted oronasal mask. This was facilitated by a mechanical ventilator operating in pressure support mode. The preoxygenation protocol entailed the administration of 100% FiO2, applying Positive End-Expiratory Pressure set at 5 cmH2O, delivering breaths at a frequency of 15 per minute, and providing a tidal volume ranging between 6 to 8 ml/kg of body weight.
| Study group | Role | What they receive |
|---|---|---|
| bag-valve mask ventilation | Experimental | Preoxygenation was administered utilizing a Compower (Fujian, China) BVM equipped with an oxygen reservoir, coupled with a correctly fitted oronasal mask. This preoxygenation procedure spanned three minutes, with an oxygen flow rate set at 15 liters per minute. Receives: Device: Bag-valve mask; Device: Noninvasive mechanical ventilation |
| noninvasive mechanical ventilation | Active comparator | Preoxygenation was conducted over a three-minute period using NIMV employing a properly fitted oronasal mask. This was facilitated by the Servo S (Maquet, Solna, Sweden) mechanical ventilator operating in pressure support mode. The preoxygenation protocol entailed the administration of 100% FiO2, applying Positive End-Expiratory Pressure (PEEP) set at 5 cmH2O, delivering breaths at a frequency of 15 per minute, and providing a tidal volume ranging between 6 to 8 ml/kg of body weight. Receives: Device: Bag-valve mask; Device: Noninvasive mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in partial pressure of oxygen in arterial blood (PaO₂) values after 3 minutes of preoxygenation
To compare PaO₂ between study groups after 3 minutes of preoxygenation (Unit of Measure: mmHg)
Measured: At the end of 3 minutes of preoxygenation
Change in partial pressure of carbon dioxide in arterial blood (PaCO₂) values after 3 minutes of preoxygenation
To compare PaCO₂ between study groups after 3 minutes of preoxygenation (Unit of Measure: mmHg)
Measured: At the end of 3 minutes of preoxygenation
Secondary outcomes (5)
Change in systolic blood pressure
Systolic arterial pressure will be recorded and compared between groups at the 5th minute after intubation
Measured: At the 5th minute after intubation
Change in diastolic blood pressure
Diastolic arterial pressure will be recorded and compared between groups. (Unit of Measure: mmHg)
Measured: At the 5th minute after intubation
Change in mean arterial pressure (MAP)
MAP will be recorded at the 5th minute after intubation (Unit of Measure: mmHg)
Measured: At the 5th minute after intubation
Change in heart rate
Heart rate will be monitored and compared between groups at the 5th minute after intubation. [Unit of Measure: beats per minute (bpm)]
Measured: At the 5th minute after intubation
Change in peripheral oxygen saturation (SpO₂)
SpO₂ will be monitored continuously and analyzed at the 5th minute after intubation. (Unit of Measure: percentage (%))
Measured: At the 5th minute after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start26 Dec 2022
- Primary completion4 May 2023
- Study completion1 Jun 2023
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 PreoxygenationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049666
- Sponsor's protocol ID
- KA22/426
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nimmagadda U, Salem MR, Crystal GJ. Preoxygenation: Physiologic Basis, Benefits, and Potential Risks. Anesth Analg. 2017 Feb;124(2):507-517. doi: 10.1213/ANE.0000000000001589.
PubMed 28099321
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoxygenation With Bag-valve-mask and Noninvasive Mechanical Ventilation on Oxygenation and Hemodynamics: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07049666
- Acronym / sponsor ID
- KA22/426
- Conditions
- Preoxygenation
- Keywords
- Preoxygenation, bag-valve-mask, noninvasive mechanical ventilation, hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 26 Dec 2022 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 3 Jul 2025 (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.
Hypoxemia refers to low blood oxygen levels, while hypoxia denotes low tissue oxygen levels. Both conditions pose life-threatening risks when precautions are not adequately taken or when risks are not effectively managed. Intubation represents a critical phase that can lead to a decrease in arterial oxyhemoglobin levels. Two frequently employed techniques for preoxygenation and ventilation during intubation are bag-valve mask (BVM) ventilation and noninvasive mechanical ventilation (NIMV). The aim of this study was to evaluate the efficacy and safety of BMV and the NIMV.
Detailed description
Ventilation and intubation challenges increase the risk of arterial desaturation, emphasizing the importance of careful management during this process. Throughout the intubation process, the oxygen reserves within the lung, plasma, hemoglobin, body mass index (BMI) play a critical role in meeting the tissue oxygen demand. Preoxygenation serves to extend the time window for intubation safely. The quantity of available oxygen reserve and the duration of the apneic period represent the primary determinants for the occurrence of hypoxemia during intubation.
Anticipating difficult intubation is crucial, as it often prolongs both the duration of intubation and the apneic period. The Intubation Difficulty Scale (IDS) is commonly utilized to predict the likelihood of encountering difficult intubation scenarios. It is imperative to select the appropriate preoxygenation technique, particularly in patients with a high IDS, to mitigate the risk of desaturation during the intubation process.
Two frequently employed techniques for preoxygenation and ventilation during intubation are BVM ventilation and NIMV. Preoxygenation, also referred to as denitrogenation, has the potential to induce atelectasis. However, this complication can be mitigated with positive pressure ventilation (PPV), which not only aids in maintaining oxygen levels but also exerts effects on the circulatory system. Hypotension is the most common symptom that occurs as a result of the interaction of the respiratory and circulatory systems.
The objective of this study was to evaluate and compare the impacts of preoxygenation with BVM and NIMV techniques on oxygenation and hemodynamic parameters specifically during the apneic period of endotracheal intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bag-valve mask ventilation | Experimental | Device: Bag-valve mask, Device: Noninvasive mechanical ventilationPreoxygenation was administered utilizing a Compower (Fujian, China) BVM equipped with an oxygen reservoir, coupled with a correctly fitted oronasal mask. This preoxygenation procedure spanned three minutes, with an oxygen flow rate set at 15 liters per minute. |
| noninvasive mechanical ventilation | Active comparator | Device: Bag-valve mask, Device: Noninvasive mechanical ventilationPreoxygenation was conducted over a three-minute period using NIMV employing a properly fitted oronasal mask. This was facilitated by the Servo S (Maquet, Solna, Sweden) mechanical ventilator operating in pressure support mode. The preoxygenation protocol entailed the administration of 100% FiO2, applying Positive End-Expiratory Pressure (PEEP) set at 5 cmH2O, delivering breaths at a frequency of 15 per minute, and providing a tidal volume ranging between 6 to 8 ml/kg of body weight. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged over 18 years
- Having a partial arterial oxygen pressure (PaO2)/fraction of inspired oxygen (FiO2) ratio exceeding 200
- Consented to participate
Key exclusion criteria (8 listed)
- Patients with an American Society of Anesthesiologists (ASA) Physical Status Classification System Score 4
- Patients with a Mallampati Score greater than 3
- Patients with a history of difficult intubation
- Patients who are pregnancy
- Patients who have hypoxia (defined as a PaO2/FiO2 ratio less than 200)
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 |
|---|---|---|
| Bag-valve maskA BVM equipped with an oxygen reservoir, coupled with a correctly fitted oronasal mask was used. | Device | bag-valve mask ventilation, noninvasive mechanical ventilation |
| Noninvasive mechanical ventilationPreoxygenation was conducted over a three-minute period using NIMV employing a properly fitted oronasal mask. This was facilitated by a mechanical ventilator operating in pressure support mode. The preoxygenation protocol entailed the administration of 100% FiO2, applying Positive End-Expiratory Pressure set at 5 cmH2O, delivering breaths at a frequency of 15 per minute, and providing a tidal volume ranging between 6 to 8 ml/kg of body weight. | Device | bag-valve mask ventilation, noninvasive mechanical ventilation |
Primary outcome
Change in partial pressure of oxygen in arterial blood (PaO₂) values after 3 minutes of preoxygenation
Time frame: At the end of 3 minutes of preoxygenation
To compare PaO₂ between study groups after 3 minutes of preoxygenation (Unit of Measure: mmHg)
Change in partial pressure of carbon dioxide in arterial blood (PaCO₂) values after 3 minutes of preoxygenation
Time frame: At the end of 3 minutes of preoxygenation
To compare PaCO₂ between study groups after 3 minutes of preoxygenation (Unit of Measure: mmHg)
5 secondary outcomes
Change in systolic blood pressure
Time frame: At the 5th minute after intubation
Change in diastolic blood pressure
Time frame: At the 5th minute after intubation
Change in mean arterial pressure (MAP)
Time frame: At the 5th minute after intubation
Change in heart rate
Time frame: At the 5th minute after intubation
Change in peripheral oxygen saturation (SpO₂)
Time frame: At the 5th minute after intubation
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 3 Jul 2025.
- Results publication: PubMed 28099321Nimmagadda U, Salem MR, Crystal GJ. Preoxygenation: Physiologic Basis, Benefits, and Potential Risks. Anesth Analg. 2017 Feb;124(2):507-517. doi: 10.1213/ANE.0000000000001589.
- Individual participant dataSharing planned: No
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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 Bag-valve mask and Noninvasive mechanical ventilation in people with Preoxygenation, run by Baskent University 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 3 inclusion and 8 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 3 Jul 2025. 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?
Change in partial pressure of oxygen in arterial blood (PaO₂) values after 3 minutes of preoxygenation (time frame: At the end of 3 minutes of preoxygenation). The study lists 2 primary outcomes in all. 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 NCT07049666, 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 3 Jul 2025.