Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2026-01-04 @ 5:16 PM
Study NCT ID:
NCT03711461
Status:
UNKNOWN
Last Update Posted:
2019-09-18
First Post:
2018-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recovery Between NIVATS and Intubated Patients
Sponsor:
National Taiwan University Hospital
Organization:
Study Overview
Official Title:
Comparisons of the Risks of Gastric Distension and Delayed Recovery of Cough Reflex and Oral Intake on Intubated and Non-intubated VATS Patients
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
the investigator aimed to observe the changes and difference of pharyngeal function parameters between the patients receiving the intubated or nonintubated thoracoscopy by esophageal manometry, impedance, and ultrasonography
Detailed Description:
Background: Anesthetic agents alter pharyngeal function with risk of impaired airway protection and aspiration. The pharyngeal function change including the swallowing and gastric regurgitation between intubated and nonintubated thoracoscopy still remains unclear.
The esophageal manometry has pressure sensor to measure the upper esophageal sphincter (UES) pressure. The manometry and impedance could detect the esophageal swallowing function during the perioperative period. The ultrasonography was used to measure the oropharyngeal swallowing function.
Objectives:the investigator aimed to observe the changes and difference of pharyngeal function parameters between the patients receiving the intubated or nonintubated thoracoscopy by esophageal manometry, impedance, and ultrasonography.
Patients and methods: Consecutive patients who will fulfill the criteria of nonintubated patients under general anesthesia and age from 20 to 80 years old will be enrolled. All subjects would receive the swallowing function by ultrasonography before the surgeries. The cough test and gastric volume were also measured. The patient was randomized by the intubated or nonintubated thoracoscopy. After induction, the endotracheal tube (ETT) will be inserted to establish airway. The non-intubated group will be use the oxygen mask and the nasal airway to maintain the airway patent. After the patients were sedated, investigators would use the video-assisted laryngoscope to let the manometry and impedance transnasal into the esophagus.These esophageal function was measured during the whole perioperative periods, especially the recovery from anesthesia in the postoperative anesthesia unit (PACU). The patients will be followed for the swallowing function by ultrasonography and cough test in the PACU, too. The oxidative test would be performed by blood test on the time, which were after anesthesia, one-lung ventilation 15 to 30 minutes, and two-lung ventilation 15 to 20 minutes, respectively.
Expected result: investigators will observe the changes between the patients receiving intubated or nonintubated thoracoscopies of the changes between the preoperative and postoperative changes in the swallowing function, cough and gastric regurgitation. The oxidative test will also be tested accompanied by the anesthetic monitoring.
The esophageal manometry has pressure sensor to measure the upper esophageal sphincter (UES) pressure. The manometry and impedance could detect the esophageal swallowing function during the perioperative period. The ultrasonography was used to measure the oropharyngeal swallowing function.
Objectives:the investigator aimed to observe the changes and difference of pharyngeal function parameters between the patients receiving the intubated or nonintubated thoracoscopy by esophageal manometry, impedance, and ultrasonography.
Patients and methods: Consecutive patients who will fulfill the criteria of nonintubated patients under general anesthesia and age from 20 to 80 years old will be enrolled. All subjects would receive the swallowing function by ultrasonography before the surgeries. The cough test and gastric volume were also measured. The patient was randomized by the intubated or nonintubated thoracoscopy. After induction, the endotracheal tube (ETT) will be inserted to establish airway. The non-intubated group will be use the oxygen mask and the nasal airway to maintain the airway patent. After the patients were sedated, investigators would use the video-assisted laryngoscope to let the manometry and impedance transnasal into the esophagus.These esophageal function was measured during the whole perioperative periods, especially the recovery from anesthesia in the postoperative anesthesia unit (PACU). The patients will be followed for the swallowing function by ultrasonography and cough test in the PACU, too. The oxidative test would be performed by blood test on the time, which were after anesthesia, one-lung ventilation 15 to 30 minutes, and two-lung ventilation 15 to 20 minutes, respectively.
Expected result: investigators will observe the changes between the patients receiving intubated or nonintubated thoracoscopies of the changes between the preoperative and postoperative changes in the swallowing function, cough and gastric regurgitation. The oxidative test will also be tested accompanied by the anesthetic monitoring.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: