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Comparison Physiological Effects According to Preoxygenation Method Using EIT (PreoxyEIT)

Primary Purpose

Acute Hypoxemic Respiratory Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HFNC
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Hypoxemic Respiratory Failure focused on measuring electrical impedence tomography, preoxygenation, intubation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients aged 18 or older Acute respiratory failure is defined as follows: Tachypnea over 30 breaths/minute / Symptoms or signs of respiratory failure / PaO2/FiO2 less than 300 When there is an indication for endotracheal intubation for mechanical ventilation When sufficient information and a consent form for the study are obtained from the patient or the patient's guardian Exclusion Criteria: Coma with Glasgow score < 8 Endotracheal intubation during CPR Contraindications for NIV: poor patient cooperation, recurrent vomiting, GI bleeding, severe craniofacial injury, upper airway obstruction, etc. Contraindications for RSI: complete upper airway obstruction, severe trauma obscuring cervical structures, etc. Implanted electronic medical devices (defibrillator, pacemaker or spinal cord stimulator) Skin damage or inadequate electrode contact due to wound dressing at the electrode site BMI > 50 Polydipsia Unmeasurable SpO2 Pregnancy or lactation

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

NIV

HFNC

Arm Description

Non-invasive ventilation application for preoxygenation

High flow oxygen therapy application for preoxygenation

Outcomes

Primary Outcome Measures

Lowest SpO2
Minimum SpO2 value during endotracheal intubation

Secondary Outcome Measures

EIT measurement
Change of T2-T1
EIT measurement
Change of △EILI
EIT measurement
Change of △EELI
EIT measurement
Change of Overdistension
EIT measurement
Change of Collapse
EIT measurement
Change of Global Inhomogeneity Index

Full Information

First Posted
July 3, 2023
Last Updated
July 18, 2023
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05962073
Brief Title
Comparison Physiological Effects According to Preoxygenation Method Using EIT
Acronym
PreoxyEIT
Official Title
A Pilot Randomized Trial of Preoxygenation Methods and Their Impacts on Endotracheal Intubation in Acute Respiratory Failure: an Electrical Impedance Tomography Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Hypoxemia during endotracheal intubation is one of this procedure's most frequent and severe complications, which can lead to cardiac arrest and other adverse outcomes. Although various studies have been conducted to ensure the safety of endotracheal intubation, most of them have focused on the physiological changes during the procedure in surgical settings, where general anesthesia is administered to healthy subjects. However, the physiological characteristics of critically ill patients who require endotracheal intubation in the intensive care unit (ICU) may differ from those of healthy subjects. When comparing the oxygen saturation-dissociation curve of healthy subjects and critically ill patients, the latter show a steeper decline in oxygen saturation (SpO2) below 90% when hypoxemia occurs. Clinically, it is difficult to maintain or recover oxygen saturation when it drops. Therefore, preoxygenation is also essential for critically ill patients with a relatively small lung reservoir, as it can help maintain higher and longer oxygen saturation during endotracheal intubation. For this reason, apneic oxygenation was proposed in the 1950s as a method of oxygen delivery during general anesthesia for surgery, and clinical randomized controlled trials (RCTs) applying it to critically ill patients in the ICU have been conducted since 20 years ago. In an observational study by Macamn et al., the adjusted odds ratio (OR) of a bag valve mask was 1, while that of a high-flow nasal cannula (HFNC) was 5.75 and that of non-invasive ventilation (NIV) was 0.10 when different preoxygenation methods were used. n FLORARI 2, a large-scale clinical RCT comparing NIV and HFNC with or without apneic oxygenation, NIV was significantly more effective than HFNC in reducing severe hypoxemia. Based on these previous studies, the investigators can infer that supplying oxygen during laryngoscopy is not very effective in preventing hypoxemia in critically ill patients. However, there is no guideline on which device to choose for preoxygenation in the ICU, and NIV or HFNC are selected according to the operator's preference. This is because few studies have examined the physiological effects of these devices on patients. Therefore, in this study, the investigators aim to compare the clinical outcomes and adverse events of NIV and HFNC as preoxygenation methods for endotracheal intubation in critically ill patients with acute respiratory failure and to evaluate their physiological effects using electrical impedance tomography.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Hypoxemic Respiratory Failure
Keywords
electrical impedence tomography, preoxygenation, intubation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Hypoxemic respiratory failure who required endotracheal intubation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NIV
Arm Type
No Intervention
Arm Description
Non-invasive ventilation application for preoxygenation
Arm Title
HFNC
Arm Type
Active Comparator
Arm Description
High flow oxygen therapy application for preoxygenation
Intervention Type
Device
Intervention Name(s)
HFNC
Intervention Description
High-flow oxygen therapy before intubation for preoxygenation
Primary Outcome Measure Information:
Title
Lowest SpO2
Description
Minimum SpO2 value during endotracheal intubation
Time Frame
at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Secondary Outcome Measure Information:
Title
EIT measurement
Description
Change of T2-T1
Time Frame
at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Title
EIT measurement
Description
Change of △EILI
Time Frame
at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Title
EIT measurement
Description
Change of △EELI
Time Frame
at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Title
EIT measurement
Description
Change of Overdistension
Time Frame
at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Title
EIT measurement
Description
Change of Collapse
Time Frame
at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Title
EIT measurement
Description
Change of Global Inhomogeneity Index
Time Frame
at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients aged 18 or older Acute respiratory failure is defined as follows: Tachypnea over 30 breaths/minute / Symptoms or signs of respiratory failure / PaO2/FiO2 less than 300 When there is an indication for endotracheal intubation for mechanical ventilation When sufficient information and a consent form for the study are obtained from the patient or the patient's guardian Exclusion Criteria: Coma with Glasgow score < 8 Endotracheal intubation during CPR Contraindications for NIV: poor patient cooperation, recurrent vomiting, GI bleeding, severe craniofacial injury, upper airway obstruction, etc. Contraindications for RSI: complete upper airway obstruction, severe trauma obscuring cervical structures, etc. Implanted electronic medical devices (defibrillator, pacemaker or spinal cord stimulator) Skin damage or inadequate electrode contact due to wound dressing at the electrode site BMI > 50 Polydipsia Unmeasurable SpO2 Pregnancy or lactation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryoung Eun Ko, MD, PhD
Phone
+82-2-3410-6399
Email
koryoungeun@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eun Jeong Choi
Phone
+82-2-3410-6399
Email
graceejchoi@gmail.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hye Rim Chung
Phone
+820234106399
Email
hyerim37.jeong@samsung.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Comparison Physiological Effects According to Preoxygenation Method Using EIT

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