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Completed

NCT Number: NCT07049666

Preoxygenation and Hemodynamics With Bag-valve-mask and Noninvasive Mechanical Ventilation

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baskent University

Adana, Yuregır, 01000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged over 18 years
  • Having a partial arterial oxygen pressure (PaO2)/fraction of inspired oxygen (FiO2) ratio exceeding 200
  • Consented to participate

Exclusion criteria

  • 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

Treatment and study plan

Bag-valve mask

Device

A BVM equipped with an oxygen reservoir, coupled with a correctly fitted oronasal mask was used.

noninvasive mechanical ventilation

Device

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.

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Change in systolic blood pressure

    Time frame: At the 5th minute after intubation

    Systolic arterial pressure will be recorded and compared between groups at the 5th minute after intubation

  2. Change in diastolic blood pressure

    Time frame: At the 5th minute after intubation

    Diastolic arterial pressure will be recorded and compared between groups. (Unit of Measure: mmHg)

  3. Change in mean arterial pressure (MAP)

    Time frame: At the 5th minute after intubation

    MAP will be recorded at the 5th minute after intubation (Unit of Measure: mmHg)

  4. Change in heart rate

    Time frame: At the 5th minute after intubation

    Heart rate will be monitored and compared between groups at the 5th minute after intubation. [Unit of Measure: beats per minute (bpm)]

  5. Change in peripheral oxygen saturation (SpO₂)

    Time frame: At the 5th minute after intubation

    SpO₂ will be monitored continuously and analyzed at the 5th minute after intubation. (Unit of Measure: percentage (%))

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

Effects of Preoxygenation With Bag-valve-mask and Noninvasive Mechanical Ventilation on Oxygenation and Hemodynamics: A Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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