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Comparison of Intubation Duration Between Rapid Sequence Intubation (RSI) Technique and Non-RSI Technique

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mingkwan Wongyingsinn, MD, Siriraj Hospital
ClinicalTrials.gov Identifier:
NCT01474252
First received: November 9, 2011
Last updated: November 17, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Tracheal Intubation Morbidity
Drug: RSI
Drug: Non-RSI
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Comparison of Intubation Duration Between Rapid Sequence Intubation Technique and Non- Rapid Sequence Intubation Technique in Siriraj Hospital by Emergency Medicine Residences

Resource links provided by NLM:


Further study details as provided by Siriraj Hospital:

Primary Outcome Measures:
  • The overall intubation duration [ Time Frame: Participants will be followed for the overall intubation duration until confirmation the endotracheal position, an expected average of 2 minutes ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • the intubation duration [ Time Frame: Participants will be followed for the intubation duration until confirmation the endotracheal position, an expected average of 5 minutes ] [ Designated as safety issue: No ]
    The intubation duration (Ti), it is defined from application the laryngoscope into the patient's mouth to the time of confirmation an endotracheal position

  • Complication [ Time Frame: Participants will be followed in the period of staying in the emergency room and hospital, an expected average of 4 weeks ] [ Designated as safety issue: Yes ]
    Complications occur during and after intubation peroid are recorded and monitored until patients are discharged fromt the hospital.


Enrollment: 224
Study Start Date: July 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RSI technique

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

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

Other Name: Rapid Sequence Intubation
No Intervention: Non-RSI
Intubation without RSI technique. No any medication use during intubation period.
Drug: Non-RSI
No medication
Other Name: Non-Rapid Sequence Intubation technique

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients required airway control by tracheal intubation

Exclusion Criteria:

  • cardiac arrest
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474252

Locations
Thailand
Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Siriraj Hospital
Investigators
Principal Investigator: Mingkwan Wongyingsinn, M.D. Siriraj Hospital
  More Information

No publications provided

Responsible Party: Mingkwan Wongyingsinn, MD, Assistant Professor, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT01474252     History of Changes
Other Study ID Numbers: SIRB213
Study First Received: November 9, 2011
Last Updated: November 17, 2011
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 19, 2014