Tracheal Intubation MorbidityPhase 4NCT01474252
Comparison of Intubation Duration Between Rapid Sequence Intubation (RSI) Technique and Non-RSI Technique
A Phase 4 study testing RSI in people with Tracheal Intubation Morbidity, run by Siriraj Hospital at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheal Intubation Morbidity
- What is being tested?
- RSI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2008to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients required airway control by tracheal intubation
Who cannot join
- cardiac arrest
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intubation Duration Between Rapid Sequence Intubation Technique and Non- Rapid Sequence Intubation Technique in Siriraj Hospital by Emergency Medicine Residences
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.
Read the detailed description
A prospective cohort study was conducted in the non-traumatic emergency department (ED).
- Conditions
- Tracheal Intubation Morbidity
- Being tested
- RSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSIDrug
Also called Rapid Sequence Intubation
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: RSI |
| Non-RSI | No intervention | Intubation without RSI technique. No any medication use during intubation period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
The intubation duration (Ti), it is defined from application the laryngoscope into the patient's mouth to the time of confirmation an endotracheal position
Measured: Participants will be followed for the intubation duration until confirmation the endotracheal position, an expected average of 5 minutes
Complication
Complications occur during and after intubation peroid are recorded and monitored until patients are discharged fromt the hospital.
Measured: Participants will be followed in the period of staying in the emergency room and hospital, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startJul 2008
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal Intubation MorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingkwan Wongyingsinn, MD, Siriraj Hospital
- Investigators
- Mingkwan Wongyingsinn, M.D., Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474252
- Sponsor's protocol ID
- SIRB213
- Status last verified
- Jun 2016
- First submitted
- 9 Nov 2011
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intubation Duration Between Rapid Sequence Intubation Technique and Non- Rapid Sequence Intubation Technique in Siriraj Hospital by Emergency Medicine Residences
- ClinicalTrials.gov ID
- NCT01474252
- Acronym / sponsor ID
- SIRB213
- Conditions
- Tracheal Intubation Morbidity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A prospective cohort study was conducted in the non-traumatic emergency department (ED).
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSI technique | Experimental | Drug: RSIIntubation 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. |
| Non-RSI | No intervention | –Intubation without RSI technique. No any medication use during intubation period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients required airway control by tracheal intubation
Key exclusion criteria (1 listed)
- cardiac arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSIAlso: Rapid Sequence IntubationAll 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 | Drug | RSI technique |
Primary outcome
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
2 secondary outcomes
the intubation duration
Time frame: Participants will be followed for the intubation duration until confirmation the endotracheal position, an expected average of 5 minutes
Complication
Time frame: Participants will be followed in the period of staying in the emergency room and hospital, an expected average of 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
Related trials for Tracheal Intubation Morbidity
Recruiting
Optimisation Strategy for Emergency Tracheal Intubation
Emergencies, Out-of-hospital Setting
Not yet recruitingPhase 2/3
Oral Melatonin VS Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients
Tracheal Intubation Morbidity, Laryngoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mingkwan Wongyingsinn, M.D. principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RSI in people with Tracheal Intubation Morbidity, run by Siriraj Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2016.