NCT01474252

Brief Summary

The purpose of this study is to evaluate intubation duration between rapid sequence intubation technique (RSI) and non-rapid sequence intubation technique (non-RSI) performed by emergency medicine residents in Siriraj hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 18, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 2, 2016

Status Verified

June 1, 2016

Enrollment Period

4.4 years

First QC Date

November 9, 2011

Last Update Submit

June 1, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • The overall intubation duration

    The overall intubation duration is recorded on the decision to intubation patient and corresponds to the time of confirmation the endotracheal position by chest auscultation

    Participants will be followed for the overall intubation duration until confirmation the endotracheal position, an expected average of 2 minutes

Secondary Outcomes (2)

  • the intubation duration

    Participants will be followed for the intubation duration until confirmation the endotracheal position, an expected average of 5 minutes

  • Complication

    Participants will be followed in the period of staying in the emergency room and hospital, an expected average of 4 weeks

Study Arms (2)

RSI technique

EXPERIMENTAL

Intubation with RSI technique. RSI technique includes the administration of inductive and neuromuscular blocking agents to facilitate an intubation. In this study, we have no restriction of medication use. Physicians can chose any of medication as an individual judgement.

Drug: RSI

Non-RSI

NO INTERVENTION

Intubation without RSI technique. No any medication use during intubation period.

Interventions

RSIDRUG

All medications are administered only one dose before intubation Anesthetics: Propofol 2-2.5 mg/kg Thiopental 3-5mg/kg Etomidate 1-2mg/kg Neuromuscular blocking agents: Succinylcholine 1-1.5mg/kg Rocuronium 0.9mg/kg Opioid: Fentanyl 1-2ug/kg

Also known as: Rapid Sequence Intubation
RSI technique

Eligibility Criteria

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

You may qualify if:

  • patients required airway control by tracheal intubation

You may not qualify if:

  • cardiac arrest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Interventions

Rapid Sequence Induction and Intubation

Intervention Hierarchy (Ancestors)

Intubation, IntratrachealAirway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • Mingkwan Wongyingsinn, M.D.

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 9, 2011

First Posted

November 18, 2011

Study Start

July 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

June 2, 2016

Record last verified: 2016-06

Locations