Emergency Tracheal Intubation in Critically Ill Patients
Conditions
Brief summary
The physiological reserves of critically ill patients are relatively low, and the risk of complications related to tracheal intubation in the ICU is higher than in the operating room. ICU tracheal intubation complications account for approximately 40% -45% of patients, including severe hypotension (10% -43%), severe hypoxemia (9% -25%), and cardiac arrest (2% -3%).Ciprofol is a novel 2,6-disubstituted phenol derivative that targeting γ-aminobutyric acid type A (GABAA)-receptor. There are four indications of ciprofol that have been approved by NMPA in recent two years: sedation and anesthesia in non-tracheal intubation procedure/operation, induction and maintenance of general anesthesia, sedation during intensive care, sedation and maintenance in gynecological outpatient surgery. The aim of this study is to compare the effects of propofol and propofol on the circulatory system during tracheal intubation in ICU patients, in order to provide a safer induction sedation regimen for emergency tracheal intubation in critically ill patients.
Interventions
DRUGCiprofol
The sedation before tracheal intubation with Ciprofol
DRUGPropofol
The sedation before tracheal intubation with Propofol
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients who need to undergo tracheal intubation under sedation after entering the ICU; * Age range from 18 to 85 years old; * Patients or their families have a full understanding of the purpose and significance of this trial, voluntarily participate in this clinical trial, and sign an informed consent form.
Exclusion criteria
* Patients who are allergic to the study drugs, or patients with contraindications to the study drugs; * Patients with difficult airways (MACOCHA ≥ 3 points); * Patients who require emergency intubation due to sudden cardiac arrest; * Patients who require conscious intubation; * Patients who can maintain mean arterial pressure (MAP) above 65mmHg using of one or more vasoactive drugs (equivalent (-)-noradrenaline \> 0.3 μg kg min); * In a state of imminent death; * Pregnant and/or lactating women; Subject judged by the investigator to have any other factors unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cardiovascular collapse within 30minutes from the start of the intubation procedure | 30 minutes from the the intubation procedure | defined as occurrence of at least one of the following events: systolic blood pressure\<65 mm Hg recorded at least once; systolic blood pressure\<90 mm Hg for\>30 minutes; SBP decreased more than 20% from baseline;new requirement for, or increase of vasopressors. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful intubation on the first attempt | 30 minutes from the the intubation procedure | Successful intubation on the first attempt |
| Time from initiation of study drug administration to successful tracheal intubation (within 30 minutes) | Time from initiation of study drug administration to successful tracheal intubation (within 30 minutes) | Time from initiation of study drug administration to successful tracheal intubation (within 30 minutes) |
| The incidence of cardiac arrest within 30 minutes after tracheal intubation | 30 minutes from the the intubation procedure | The incidence of cardiac arrest within 30 minutes after tracheal intubation |
| The incidence of bradycardia within 30 minutes after tracheal intubation | 30 minutes from the the intubation procedure | The incidence of bradycardia within 30 minutes after tracheal intubation |
| The incidence of hypoxemia within 30 minutes after tracheal intubation | 30 minutes from the the intubation procedure | The incidence of hypoxemia within 30 minutes after tracheal intubation |
| Success rate of sedation | 30 minutes from the the intubation procedure | Success rate of sedation |
| new requirement or increase of antiarrhythmic drugs | 30 minutes from the the intubation procedure | new requirement or increase of antiarrhythmic drugs |
| Length of ICU stay and treatment outcome | From the start of randomization until patients were transferred out of the ICU or discharged | Length of ICU stay and treatment outcome |
| 28 days without mechanical ventilation | From the beginning of patients enrolled to 28 days after enrollment | 28 days without mechanical ventilation |
| 28-day mortality rate | within 28 days | 28-day mortality rate |
| new requirement or increase of vasopressors | 30 minutes from the the intubation procedure | new requirement or increase of vasopressors |
Countries
China
Outcome results
None listed