ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01474252
Recruitment Status : Completed
First Posted : November 18, 2011
Last Update Posted : June 2, 2016
Sponsor:
Information provided by (Responsible Party):
Mingkwan Wongyingsinn, MD, Siriraj Hospital

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.

Condition or disease Intervention/treatment Phase
Tracheal Intubation Morbidity Drug: RSI Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 ]
    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 :
  1. the intubation duration [ Time Frame: Participants will be followed for the intubation duration until confirmation the endotracheal position, an expected average of 5 minutes ]
    The intubation duration (Ti), it is defined from application the laryngoscope into the patient's mouth to the time of confirmation an endotracheal position

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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients required airway control by tracheal intubation

Exclusion Criteria:

  • cardiac arrest

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474252


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

Responsible Party: Mingkwan Wongyingsinn, MD, Assistant Professor, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT01474252     History of Changes
Other Study ID Numbers: SIRB213
First Posted: November 18, 2011    Key Record Dates
Last Update Posted: June 2, 2016
Last Verified: June 2016

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