Airway Control Clinical Trial
Official title:
Conventional Sedation Compaired With THRIVE Under General Anesthesia in Endotracheal Intubation by Fiberbronchoscope in Patients With Difficult Airways,A Randomized Controlled Study
Verified date | April 2022 |
Source | Peking University |
Contact | Xudong Yang, MD |
Phone | 62179977 |
kqyangxudong[@]163.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare the difference in endotracheal intubation in participants with difficult airway between under general anesthesia by Transnasal Humidified Rapid-Insufflation Ventilatory Exchange and under traditional sedation by mask ventilation. The investigators focus on the different outcomes in oxygenation maintaince, carbon dioxide removal and the effectiveness of safety apnea time, to evaluate the safety of receiving endotracheal intubation under general anesthesia in participants with difficult airway.
Status | Recruiting |
Enrollment | 42 |
Est. completion date | June 10, 2022 |
Est. primary completion date | May 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria - Age 18-60 - Patients with difficult airway assessed by two anesthesiologists according to the difficult airway score who needed to undergo nasal endotracheal intubation for oral and maxillofacial surgery in Peking University Stomatological Hospital. - BMI between 18 to 30 kg/m2 - ASA Grade I to II - NYHA grade I - Patients requiring arterial hemodynamics monitoring and blood gas analysis due to surgical requirements - Signed the informed consent Exclusion Criteria - Respiratory diseases: respiratory failure, COPD, pulmonary fibrosis, asthma and other diseases. Patients with ventilatory dysfunction or airway obstruction. - NYHA cardiac function grade greater than I, or NYHA cardiac function grade I but with a history of coronary heart disease. - Conditions affecting the monitoring of peripheral oxygen saturation, such as poor peripheral circulation perfusion and application of vasoconstrictor, are present. - Indoor oxygen saturation below 92%. - Patients who cannot tolerate rapid exchange ventilation with nasal humidification. - Patients with a history of easy nasal bleeding. - Inability to understand or express pain scores. - Menstrual period and lactation period of female patients. - The patient has mental illness. - Patients with severe intraoperative complications should be removed after surgery |
Country | Name | City | State |
---|---|---|---|
China | Peking University Hospital of Stomatology | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood oxygen pressure | Blood oxygen pressure after intubation immediately. | Day 0 | |
Primary | Pulse oxygen saturation | Pulse oxygen saturation after intubation immediately. | Day 0 | |
Primary | Blood carbon dioxide pressure | Blood carbon dioxide pressure after intubation immediately. | Day 0 | |
Secondary | Endtidal CO2 | Endtidal CO2 at time point of TA?TB?TC?TD | Day 0 | |
Secondary | Success of intubation | Proportion of successful endotracheal intubation | Day 0 | |
Secondary | Arrhythmias or dramatic haemodynamic fluctuations | Arrhythmias and dramatic fluctuations in heart rate and blood pressure: types and times of arrhythmias in the test were recorded. Changes in heart rate and blood pressure more than 30% before surgery were recorded as dramatic fluctuations. | Day 0 | |
Secondary | Tolerance of intubation | The score of patient's tolerance to endotracheal intubation one day after surgery (0-10 points, 0 point is completely intolerable, 10 point is completely intolerable) | Day 1 | |
Secondary | Time to complete intubation | Time required to complete endotracheal intubation | Day 0 | |
Secondary | SPO2 below 95% | Percentage of patients with pulse oxygen saturation below 95% during the trial | Day 0 | |
Secondary | SPO2 below 92% | Percentage of patients with pulse oxygen saturation below 92% during the trial | Day 0 |
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