Esophageal Cancer Clinical Trial
Official title:
The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway Reduce the Incidence of Hypoxia in Patients Undergoing Gastrointestinal Endoscopy Sedated With Propofol.
Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy with propofol. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of our randomized study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway reduce the incidence of hypoxia on patients undergoing gastrointestinal endoscopy under propofol sedation.
Status | Not yet recruiting |
Enrollment | 1200 |
Est. completion date | October 9, 2024 |
Est. primary completion date | October 9, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Age 18= Age =60. - Patients undergoing gastroendoscopy and/or colonoscopy procedure. - Patients have signed the informed consent form. - The ASA classification ranges from I to II. - The estimated duration of the procedure does not exceed 45 minutes. Exclusion Criteria: - Patients who exhibit contraindications to oropharyngeal airway ventilation, such as coagulation disorders, a predisposition to oral and nasal bleeding, mucosal damage, or anatomical constraints impeding oropharyngeal channel placement. - Severe cardiac insufficiency, defined as a maximal exercise capacity of less than 4 metabolic equivalents (METs). - Profound renal insufficiency necessitating preoperative dialysis. - A confirmed severe liver dysfunction. - Patients diagnosed with chronic obstructive pulmonary disease (COPD) or those presently experiencing other acute and chronic pulmonary conditions necessitating prolonged or intermittent oxygen therapy. - Elevated intracranial pressure. - Upper respiratory tract infections, encompassing the oral, nasal, and pharyngeal regions. - Fever, defined as a core body temperature exceeding 37.5 degrees Celsius. - Pregnancy or lactation. - Hypersensitivity reactions to sedatives like propofol or medical equipment such as adhesive tape. - Urgent surgical intervention. - Polytrauma. - Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively. - BMI<18.5 or BMI>30. - Patients with a documented history of substance abuse, specifically drugs and/or alcohol, within the two years preceding the commencement of the screening period. Substance abuse in this context is defined as consuming more than three standard alcoholic beverages daily, roughly equivalent to 10g of alcohol or 50g of Chinese Baijiu. - Patients with a history of mental and neurological disorders, including but not limited to depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease, and myasthenia gravis. - Presently engaged in concurrent participation in additional clinical trials. - Patients considered ineligible by researchers for inclusion in this clinical trial. |
Country | Name | City | State |
---|---|---|---|
China | Shangdong Provincial Qianfoshan Hospital | Jinan | Shandong |
China | The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu |
China | Fudan University Shanghai Cancer Center | Shanghai | Shanghai |
China | Renji Hospital | Shanghai | Shanghai |
China | Tianjin Mediacal University General Hospital | Tianjin | Tianjin |
China | The First Affliated Hospital of Xi'an Jiangtong University | Xi'an | Shanxi |
Lead Sponsor | Collaborator |
---|---|
RenJi Hospital | First Affiliated Hospital Xi'an Jiaotong University, Fudan University, Qianfoshan Hospital, The First Affiliated Hospital with Nanjing Medical University, Tianjin Medical University General Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The incidence of other adverse events | Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | |
Primary | The incidence of hypoxia | (75% = SpO2 < 90% for <60 s) | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | |
Secondary | The incidence of sub-clinical respiratory depression | (90% = SpO2 < 95%) | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | |
Secondary | The incidence of severe hypoxia | (SpO2 < 75% or 75% = SpO2 < 90% for =60 s) | Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT01624090 -
Mithramycin for Lung, Esophagus, and Other Chest Cancers
|
Phase 2 | |
Recruiting |
NCT05787522 -
Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
|
||
Not yet recruiting |
NCT05542680 -
Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer
|
N/A | |
Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
Completed |
NCT00003864 -
Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus
|
Phase 2 | |
Recruiting |
NCT05491616 -
Nivolumab During Active Surveillance After Neoadjuvant Chemoradiation for Esophageal Cancer: SANO-3 Study
|
Phase 2 | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Completed |
NCT00199849 -
NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine
|
Phase 1 | |
Completed |
NCT03756597 -
PAN-study: Pan-Cancer Early Detection Study (PAN)
|
||
Completed |
NCT00400114 -
Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer
|
Phase 2 | |
Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
Recruiting |
NCT04615806 -
The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Esophagectomy
|
N/A | |
Active, not recruiting |
NCT04566367 -
Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer
|
N/A | |
Active, not recruiting |
NCT03962179 -
Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent)
|
N/A | |
Terminated |
NCT01446874 -
Prevention of Post-operative Pneumonia (POPP)
|
Phase 2/Phase 3 | |
Completed |
NCT03468634 -
Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy
|
N/A | |
Active, not recruiting |
NCT02869217 -
Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors
|
Phase 1 | |
Completed |
NCT02810652 -
Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection
|
N/A | |
Recruiting |
NCT01404156 -
Preoperative Chemotherapy vs. Chemoradiation in Esophageal / GEJ Adenocarcinoma
|
Phase 2/Phase 3 |