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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01474252
Other study ID # SIRB213
Secondary ID
Status Completed
Phase Phase 4
First received November 9, 2011
Last updated June 1, 2016
Start date July 2008
Est. completion date December 2013

Study information

Verified date June 2016
Source Siriraj Hospital
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial 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.


Description:

A prospective cohort study was conducted in the non-traumatic emergency department (ED).


Recruitment information / eligibility

Status Completed
Enrollment 224
Est. completion date December 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients required airway control by tracheal intubation

Exclusion Criteria:

- cardiac arrest

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Drug:
RSI
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

Locations

Country Name City State
Thailand Siriraj Hospital Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary the intubation duration The intubation duration (Ti), it is defined from application the laryngoscope into the patient's mouth to the time of confirmation an endotracheal position Participants will be followed for the intubation duration until confirmation the endotracheal position, an expected average of 5 minutes No
Secondary Complication Complications occur during and after intubation peroid are recorded and monitored until patients are discharged fromt the hospital. Participants will be followed in the period of staying in the emergency room and hospital, an expected average of 4 weeks Yes
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