Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578468
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
End-Tidal Oxygen for Intubation in the Emergency Department
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Preoxygenation Using End-Tidal Oxygen for Rapid Sequence Intubation in the Emergency Department The PREOXED Trial - a Multicentre Stepped Wedge Cluster Randomised Control Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREOXED
Brief Summary:
Rapid Sequence Intubation RSI is a high-risk procedure in the emergency department ED Patients are routinely preoxygenated given supplemental oxygen prior to RSI to prevent hypoxia during intubation For many years anaesthetists have used end-tidal oxygen ETO2 levels to guide the effectiveness of preoxygenation prior to intubation The ETO2 gives an objective measurement of preoxygenation efficacy This is currently not available in most EDs
This trial evaluates the use of ETO2 on the rate of hypoxia during intubation for patients in the ED
This trial evaluates the use of ETO2 on the rate of hypoxia during intubation for patients in the ED
Detailed Description:
BACKGROUND AND INTRODUCTION
Rapid Sequence Intubation RSI is a common procedure in Emergency Departments ED However it is a high-risk procedure and is associated with significant complications including hypoxia failed intubation hypotension trauma and aspiration 1-3 Specifically hypoxia during intubation can lead to poor outcomes such as dysrhythmias haemodynamic compromise hypoxic brain injury and death and therefore oxygen desaturation is of primary concern during any intubation procedure 4 5 In order to prevent desaturation events during intubation a number of steps are taken by clinicians These include optimal patient positioning adequate preoxygenation assessment of airway anatomy and development of a detailed airway plan as well as the use of apnoeic oxygenation6
Effective preoxygenation is vital to ensure that the patient does not develop hypoxia during the period between induction administration of sedative and paralytic agents and restoration of ventilation by successful endotracheal intubation or rescue breathing Various methods of preoxygenation have been developed to wash the nitrogen out of the lungs denitrogenation which allows the functional residual capacity FRC to act as an oxygen reservoir during intubation which prolongs safe apnoea time therefore preventing desaturation whilst an endotracheal tube ETT is placed
Adequate preoxygenation is especially important for those patients at highest risk of hypoxia during the RSI This patient group includes those with underlying lung pathology eg pneumonia patients with increased metabolic demand eg sepsis patients with an oxygen requirement prior to RSI or patients with underlying conditions that predisposes to hypoxia eg obesity
For many years anaesthetists have used end-tidal oxygen ETO2 levels to guide the effectiveness of preoxygenation ETO2 measures the exhaled oxygen concentration and is a marker of the oxygen concentration in the alveoli Prior to induction anaesthetists most commonly preoxygenate with a face-mask seal via either a circle circuit Mapleson circuit or bag valve mask ETO2 provides an objective measurement of preoxygenation efficacy The Difficult Airway Society guidelines suggest aiming for an ETO2 of 87 prior to commencing RSI7 ETO2 levels are not routinely measured in Emergency Departments
Currently it is not possible to measure the effectiveness of preoxygenation in the ED Pulse-wave oximetry reflects peripheral oxygen saturation and not the pulmonary oxygen concentration Therefore to attempt to optimize preoxygenation the emergency clinician currently can only use time as a surrogate The typically recommended duration of preoxygenation is 3 minutes
Recently the investigators conducted two multi-site studies Ethics identifier 2019ETH06644 that investigated the use of ETO2 in the ED8 9 The first study was conducted with clinicians blinded to the ETO2 result 8 The investigators demonstrated that preoxygenation was uniformly poor with only 26 of patients achieving the required target ETO2 of 85 The investigators then completed a second study where clinicians had access to ETO2 values and found that the proportion of patients reaching levels 85 was improved to 67 of patients 9 The prevalence of hypoxemia SpO2 90 in the group blinded to ETO2 was 18 n18 95 CI 11 to 27 and was 8 in the group where ETO2 was available n 8 95 CI 4 to 15 These studies indicate that the use of ETO2 may substantially improve preoxygenation in the ED and therefore reduce the risk of hypoxia
These studies however were focused on preoxygenation practices and not patient-oriented outcomes hypoxia and were limited in design and resources Consequently it is still unclear whether the use of ETO2 in the ED leads to improved clinical outcomes
RATIONALE FOR PERFORMING THE STUDY
The aim of this study is to determine the effectiveness of ETO2 monitoring in preventing desaturation for patients with a high risk of hypoxia undergoing RSI in ED
HYPOTHESIS
The investigators hypothesise that the use of ETO2 monitoring leads to reduced rates of oxygen desaturation during the peri-intubation period compared to when it is not used
Rapid Sequence Intubation RSI is a common procedure in Emergency Departments ED However it is a high-risk procedure and is associated with significant complications including hypoxia failed intubation hypotension trauma and aspiration 1-3 Specifically hypoxia during intubation can lead to poor outcomes such as dysrhythmias haemodynamic compromise hypoxic brain injury and death and therefore oxygen desaturation is of primary concern during any intubation procedure 4 5 In order to prevent desaturation events during intubation a number of steps are taken by clinicians These include optimal patient positioning adequate preoxygenation assessment of airway anatomy and development of a detailed airway plan as well as the use of apnoeic oxygenation6
Effective preoxygenation is vital to ensure that the patient does not develop hypoxia during the period between induction administration of sedative and paralytic agents and restoration of ventilation by successful endotracheal intubation or rescue breathing Various methods of preoxygenation have been developed to wash the nitrogen out of the lungs denitrogenation which allows the functional residual capacity FRC to act as an oxygen reservoir during intubation which prolongs safe apnoea time therefore preventing desaturation whilst an endotracheal tube ETT is placed
Adequate preoxygenation is especially important for those patients at highest risk of hypoxia during the RSI This patient group includes those with underlying lung pathology eg pneumonia patients with increased metabolic demand eg sepsis patients with an oxygen requirement prior to RSI or patients with underlying conditions that predisposes to hypoxia eg obesity
For many years anaesthetists have used end-tidal oxygen ETO2 levels to guide the effectiveness of preoxygenation ETO2 measures the exhaled oxygen concentration and is a marker of the oxygen concentration in the alveoli Prior to induction anaesthetists most commonly preoxygenate with a face-mask seal via either a circle circuit Mapleson circuit or bag valve mask ETO2 provides an objective measurement of preoxygenation efficacy The Difficult Airway Society guidelines suggest aiming for an ETO2 of 87 prior to commencing RSI7 ETO2 levels are not routinely measured in Emergency Departments
Currently it is not possible to measure the effectiveness of preoxygenation in the ED Pulse-wave oximetry reflects peripheral oxygen saturation and not the pulmonary oxygen concentration Therefore to attempt to optimize preoxygenation the emergency clinician currently can only use time as a surrogate The typically recommended duration of preoxygenation is 3 minutes
Recently the investigators conducted two multi-site studies Ethics identifier 2019ETH06644 that investigated the use of ETO2 in the ED8 9 The first study was conducted with clinicians blinded to the ETO2 result 8 The investigators demonstrated that preoxygenation was uniformly poor with only 26 of patients achieving the required target ETO2 of 85 The investigators then completed a second study where clinicians had access to ETO2 values and found that the proportion of patients reaching levels 85 was improved to 67 of patients 9 The prevalence of hypoxemia SpO2 90 in the group blinded to ETO2 was 18 n18 95 CI 11 to 27 and was 8 in the group where ETO2 was available n 8 95 CI 4 to 15 These studies indicate that the use of ETO2 may substantially improve preoxygenation in the ED and therefore reduce the risk of hypoxia
These studies however were focused on preoxygenation practices and not patient-oriented outcomes hypoxia and were limited in design and resources Consequently it is still unclear whether the use of ETO2 in the ED leads to improved clinical outcomes
RATIONALE FOR PERFORMING THE STUDY
The aim of this study is to determine the effectiveness of ETO2 monitoring in preventing desaturation for patients with a high risk of hypoxia undergoing RSI in ED
HYPOTHESIS
The investigators hypothesise that the use of ETO2 monitoring leads to reduced rates of oxygen desaturation during the peri-intubation period compared to when it is not used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None