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

NCT07049666 | Completed

• 1 other identifier: KA22/426
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Preoxygenation

Keywords

Preoxygenation; bag-valve-mask; noninvasive mechanical ventilation; hemodynamics

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  At the end of 3 minutes of preoxygenation

Secondary Outcomes (5)

• Change in systolic blood pressure

  At the 5th minute after intubation

• Change in diastolic blood pressure

  At the 5th minute after intubation

• Change in mean arterial pressure (MAP)

  At the 5th minute after intubation

• Change in heart rate

  At the 5th minute after intubation

• Change in peripheral oxygen saturation (SpO₂)

  At the 5th minute after intubation

Study Arms (2)

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.

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.

Device: Bag-valve mask; Device: Noninvasive mechanical ventilation

Interventions

Bag-valve mask DEVICE

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

bag-valve mask ventilation; noninvasive mechanical ventilation

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.

bag-valve mask ventilation; noninvasive mechanical ventilation

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University

Adana, Yuregır, 01000, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 28099321 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 3, 2025
• Study Start: December 26, 2022
• Primary Completion: May 4, 2023
• Study Completion: June 1, 2023
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)