Recovery Between NIVATS and Intubated Patients
Comparisons of the Risks of Gastric Distension and Delayed Recovery of Cough Reflex and Oral Intake on Intubated and Non-intubated VATS Patients
1 other identifier
interventional
32
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2018
CompletedFirst Posted
Study publicly available on registry
October 18, 2018
CompletedStudy Start
First participant enrolled
November 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2023
CompletedSeptember 18, 2019
October 1, 2018
2 years
October 11, 2018
September 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
impedance changes
using esophageal manometry to evaluate the swallowing
average 4 hours
Secondary Outcomes (2)
esophageal pressure changes
average 4 hours
hyoid bone distance
average 4 hours
Study Arms (2)
nonintubated
ACTIVE COMPARATORpatients received nonintubated during thoracoscopy
intubated
EXPERIMENTALpatients receiving intubated during thoracoscopy
Interventions
patients routinely use double lumen endotracheal intubation while they have received thoracoscopy
patients receiving nonintubated anesthetic plan while they have received thoracoscopy
Eligibility Criteria
You may qualify if:
- Patients who fulfill the criteria of nonintubated thoracoscopy under general anesthesia, including tumours smaller than 6 cm, peripheral lesions, no evidence of severe adhesion; and no evidence of chest wall, diaphragm, or main bronchus involvement. Patients who had potential or confirmed airway complications such as bronchial tumor or hemothorax, morbid obesity (BMI greater than 35 kg·m-2), coagulopathy, anatomical deformity or an American Society of Anesthesiology (ASA) classification greater than 3 were excluded
- Aged from 20-80 years old
You may not qualify if:
- Major systemic disease, such as congestive heart failure, liver cirrhosis, and end stage renal disease.
- Patients who have the risk of difficult ventilation or intubation.
- pregnant women
- coagulopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ya-Jung Cheng
Taipei, 10002, Taiwan
Study Officials
- PRINCIPAL INVESTIGATOR
Ya-Jung Cheng, MD
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- the swallowing function assessor is blind
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2018
First Posted
October 18, 2018
Study Start
November 2, 2018
Primary Completion
October 25, 2020
Study Completion
October 25, 2023
Last Updated
September 18, 2019
Record last verified: 2018-10