NCT06667336

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

2.7 years

First QC Date

October 28, 2024

Last Update Submit

January 9, 2025

Conditions

Keywords

RSIEmergency DepartmentResuscitation

Outcome Measures

Primary Outcomes (1)

  • Oxygen saturation achieved (SpO2)

    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 Outcomes (6)

  • Incidence of Desaturation

    2 minutes

  • Lowest O2 Saturation

    2 minutes

  • End-Tidal Oxygen Concentration ( ETO2)

    2 minutes

  • Time from Preoxygenation

    5 minutes

  • Complications During RSI

    1 minute

  • +1 more secondary outcomes

Study Arms (2)

Intermittent Suction

ACTIVE COMPARATOR

This suction was applied only as needed to clear secretions

Procedure: intermittent suction

Continuous Suction

ACTIVE COMPARATOR

The suction catheter was inserted at the start of laryngoscopy and maintained in the oropharynx until the moment of ETT delivery

Procedure: continuous suction

Interventions

This suction was applied only as needed to clear secretions

Intermittent Suction

The suction catheter was inserted at the start of laryngoscopy and maintained in the oropharynx until the moment of ETT delivery.

Continuous Suction

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Emergency Medicine Patients
  • Requiring Rapid Sequence Intubation in the Resuscitation Bay
  • years+

You may not qualify if:

  • Patients that have a heavily soiled airway (i.e. secretions, vomitus, blood)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2024

First Posted

October 31, 2024

Study Start

September 1, 2021

Primary Completion

May 31, 2024

Study Completion

October 28, 2024

Last Updated

January 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations