The Impact of Suctioning on Oxygenation During RSI in the Emergency Department

January 9, 2025 updated by: Maimonides Medical Center

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

Completed

Conditions

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

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

October 28, 2024

Study Registration Dates

First Submitted

October 28, 2024

First Submitted That Met QC Criteria

October 29, 2024

First Posted (Actual)

October 31, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-01-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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