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

Not Applicable
Completed
Conditions
Preoxygenation
Registration Number
NCT07049666
Lead Sponsor
Baskent University
Brief 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. 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
128
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change in partial pressure of oxygen in arterial blood (PaO₂) values after 3 minutes of preoxygenationAt 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 preoxygenationAt the end of 3 minutes of preoxygenation

To compare PaCO₂ between study groups after 3 minutes of preoxygenation (Unit of Measure: mmHg)

Secondary Outcome Measures
NameTimeMethod
Change in systolic blood pressureAt the 5th minute after intubation

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

Change in diastolic blood pressureAt the 5th minute after intubation

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

Change in mean arterial pressure (MAP)At the 5th minute after intubation

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

Change in heart rateAt the 5th minute after intubation

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

Change in peripheral oxygen saturation (SpO₂)At the 5th minute after intubation

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

Trial Locations

Locations (1)

Baskent University

🇹🇷

Adana, Yuregır, Turkey

Baskent University
🇹🇷Adana, Yuregır, Turkey
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