- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07741578
Sequential Order of RSI on Tracheal Intubation
The Impact of Sequential Order of Emergency Sedation and Neuromuscular Blocking Agent During Rapid Sequence Induction on Tracheal Intubation
This clinical trial aims to understand the effect of the order of administration of Neuromuscular Blocking Agents (NMBAs) and sedatives on the success rate of intubation during Rapid Sequence Intubation (RSI) in the emergency department. The main questions to be answered include:
- The impact of sequential drug administration order during rapid sequence induction (RSI) on first-pass intubation success rates.
- Time to successful intubation
- Hypoxia incidence (SpO₂ <90%)
- Risk of post-traumatic stress disorder (PTSD)
- Procedure-related complications
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Wuhan, China
- Zhongnan Hospital of Wuhan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- in ED/EICU required emergency intubation
- RSI required
Exclusion Criteria:
- Pregnancy
- do not intubation orders
- Declined participation
- Other trials
- Non-emergent cases
- Active CPR
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Sedative to NMBA
Sedative(Propofol) →within 30s→ NMBA(Rocuronium) → Intubation
|
|
|
Experimental: NMBA to Sedative
NMBA(Rocuronium) →within 30s→ Sedative(Propofol) → Intubation
|
Control: Sedative ( Propofol ) →within 30s→ NMBA ( Rocuronium ) → Intubation → 5min → Measure vital signs → After treatment → Remove tracheal intubation→ Recall of intubation Intervention: NMBA ( Rocuronium ) →within 30s→ Sedative(Propofol) → Intubation → 5min → Measure vital signs → After treatment → Remove tracheal intubation→ Recall of intubation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
First-pass success rate
Time Frame: Perioperative
|
Successful intubation on the first attempt, confirmed by any one of: Direct visualization of the ETT passing through vocal cords Bilateral breath sounds on auscultation Fiberoptic bronchoscopic confirmation of tracheal placement Sustained end-tidal CO₂ waveform (EtCO₂ >15 mmHg for ≥3 breaths) |
Perioperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to intubation
Time Frame: Perioperative
|
from laryngoscopy start to confirmation (seconds)
|
Perioperative
|
|
Intubation recall
Time Frame: From drug injection to Remove the endotracheal tube
|
From drug injection to Remove the endotracheal tube
|
|
|
Changes in SBP
Time Frame: Perioperative
|
ΔSBP, :SBPₜ₀ - SBPₜ₁ ; (SBPₜ₀ - SBPₜ₁)/SBPₜ₀ × 100%
|
Perioperative
|
|
Changes in HR
Time Frame: Perioperative
|
ΔHR (absolute and percentage change):HRₜ₀ - HRₜ₁ ; (HRₜ₀ - HRₜ₁)/HRₜ₀ × 100%
|
Perioperative
|
|
Changes in SpO₂
Time Frame: Perioperative
|
ΔSpO₂ (absolute and percentage change):SpO₂ₜ₀ - SpO₂ₜ₂ₘᵢₙ ; (SpO₂ₜ₀ - SpO₂ₜ₂ₘᵢₙ)/SpO₂ₜ₀ × 100%
|
Perioperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ZKL-KY-2024-008 (Other Grant/Funding Number: China Health Charity Foundation)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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