- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06667336
The Impact of Suctioning on Oxygenation During RSI in the Emergency Department
The Impact of Suctioning on Oxygenation During RSI in the Emergency Department-A Multi-Center Pilot Study
Rapid Sequence Intubation (RSI) is a common procedure in Emergency Departments (ED). However, it is a high-risk procedure and has been associated with significant complications including hypoxia, hypotension, airway trauma, aspiration, and death. Specifically, hypoxic episodes during intubation can lead to poor outcomes such as dysrhythmias, haemodynamic compromise, hypoxic brain injury and cardiac arrest, and is therefore of primary concern during any intubation procedure. Aspiration is a serious adverse event and potential cause of hypoxia during RSI and can lead to poor patient outcomes downstream of the procedure. The reported incidence of aspiration during RSI in the ED ranges from 3 to 8% in the ED population. In order to achieve an optimal view of the glottis and prevent pulmonary aspiration of fluids in the oropharynx, providers apply suction prior to and during laryngoscopy, using a Yankauer or large-bore suction catheter.
There is currently significant variation in suctioning during laryngoscopy, with some providers using very little suction as needed to clear heavy fluids (judicious suctioning), while others utilise suction aggressively (lead with suction) and as a part of their routine laryngoscopy technique. Evidence suggests inline suction on already-intubated patients accelerates desaturation, but we are aware of no studies examining the impact suctioning has on the speed of desaturation during emergent endotracheal intubation.
This pilot study aims to compare the effects of intermittent, as-needed "judicious" suctioning versus aggressive "continuous" (lead with) suctioning on oxygenation during rapid sequence intubation in the emergency department.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Intervention
The aim of this study is to investigate the effect of suctioning (a current technique used conventionally in RSI) on oxygenation levels during RSI. This being noted, there is no new intervention being applied to the patient.
In order to investigate this, the current standard of care of suctioning will be used either by judicious means (i.e. in and out suction as needed) or continuous means (i.e. throughout the procedure, including laryngoscopy and tube placement) according to conventional practice at the discretion of the treating physician. For all patients involved in the study, there will be no new intervention applied. The impact of the use of suctioning, again which is standard of care and applied by convention, will be determined by measuring oxygen saturation as a primary outcome. All aspects of RSI will be at the discretion of the treating clinician, which is the current standard, including induction/relaxant medication, positioning of the patient, preoxygenation method, method of intubation and post-intubation sedation. At all institutions RSI is performed in a similar manner utilising an airway checklist (Appendix 1 and 2). However, there are no 'Standard Operating Procedures' for RSI in any ED and therefore intubation technique will vary depending on clinician preference and the clinical circumstances.
Once the decision to perform RSI has been made by the treating team, the patient will be enrolled into either a judicious or continuous suction group at random. In either case, suctioning will be applied to the patient as determined necessary by the clinician. Rapid sequence intubation will then be performed in the standard means by the treating provider.
Data Collection
The data will be collected prospectively during the time of RSI by nursing and medical staff with the use of a data collection sheet. Staff at RPA ED are familiar with the data collection sheets as prior studies in relation to RSI have been performed previously (Study number Re: X12- 0394). Similarly, staff at Lincoln Medical Center and Mount Sinai perform routine data collection on all RSI's performed in the ED for quality improvement purposes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Brooklyn, New York, United States, 11219
- Maimonides Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Emergency Medicine Patients
- Requiring Rapid Sequence Intubation in the Resuscitation Bay
- 18 years+
Exclusion Criteria:
- Patients that have a heavily soiled airway (i.e. secretions, vomitus, blood)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Intermittent Suction
This suction was applied only as needed to clear secretions
|
This suction was applied only as needed to clear secretions
|
|
Active Comparator: Continuous Suction
The suction catheter was inserted at the start of laryngoscopy and maintained in the oropharynx until the moment of ETT delivery
|
The suction catheter was inserted at the start of laryngoscopy and maintained in the oropharynx until the moment of ETT delivery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oxygen saturation achieved (SpO2)
Time Frame: 10 minutes
|
the oxygen saturation achieved (SpO2) at the time of tube placement (via confirmation with first ETCO2 waveform) achieved during the intubation period.
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Desaturation
Time Frame: 2 minutes
|
Incidence of desaturation (SaO2 <90%) or >10 points from baseline during the intubation period
|
2 minutes
|
|
Lowest O2 Saturation
Time Frame: 2 minutes
|
Lowest O2 saturations at any point during the intubation period
|
2 minutes
|
|
End-Tidal Oxygen Concentration ( ETO2)
Time Frame: 2 minutes
|
The ETO2 at induction and at Endotracheal Tube (ETT) confirmation.
|
2 minutes
|
|
Time from Preoxygenation
Time Frame: 5 minutes
|
Time from preoxygenation to endotracheal intubation
|
5 minutes
|
|
Complications During RSI
Time Frame: 1 minute
|
Complications during RSI: bradycardia, tachycardia, hypotension, hypertension, oesophageal intubation, aspiration, airway or dental trauma, equipment or medication error
|
1 minute
|
|
Intubation Attempts
Time Frame: 1 minute
|
Number of intubation attempts
|
1 minute
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-01-32
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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