Esophageal Function in ThoracoscopyNCT03711461
Recovery Between NIVATS and Intubated Patients
A study testing endotracheal tube (double lumen) and nonintubated in people with Esophageal Function in Thoracoscopy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Esophageal Function in Thoracoscopy
- What is being tested?
- endotracheal tube (double lumen) and nonintubated
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Nov 2018to 25 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Ya-Jung Cheng
Taipei, 10002
Ya-Jung Cheng, MD, 0223123456, chengyj@ntu.edu.tw
About this study
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
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
Read the 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.
- Conditions
- Esophageal Function in Thoracoscopy
- Being tested
- endotracheal tube (double lumen), nonintubated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endotracheal tube (double lumen)Device
patients routinely use double lumen endotracheal intubation while they have received thoracoscopy
nonintubatedDevice
patients receiving nonintubated anesthetic plan while they have received thoracoscopy
| Study group | Role | What they receive |
|---|---|---|
| nonintubated | Active comparator | patients received nonintubated during thoracoscopy Receives: Device: nonintubated |
| intubated | Experimental | patients receiving intubated during thoracoscopy Receives: Device: endotracheal tube (double lumen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
impedance changes
using esophageal manometry to evaluate the swallowing
Measured: average 4 hours
Secondary outcomes (2)
esophageal pressure changes
using esophageal manometry to evaluate the swallowing
Measured: average 4 hours
hyoid bone distance
using ultrasound to evaluate the swallowing
Measured: average 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start2 Nov 2018
- Primary completion25 Oct 2020 (estimated)
- Study completion25 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Function in ThoracoscopyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intubated and nonintubated patients
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ya-Jung Cheng, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711461
- Sponsor's protocol ID
- 201804093RIND
- Status last verified
- Oct 2018
- First submitted
- 11 Oct 2018
- Last updated
- 18 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03711461
- Acronym / sponsor ID
- 201804093RIND
- Conditions
- Esophageal Function in Thoracoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 25 Oct 2020 (estimated)
- Study completion
- 25 Oct 2023 (estimated)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- intubated and nonintubated patients
| Arm | Type | Receives |
|---|---|---|
| nonintubated | Active comparator | Device: nonintubatedpatients received nonintubated during thoracoscopy |
| intubated | Experimental | Device: endotracheal tube (double lumen)patients receiving intubated during thoracoscopy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endotracheal tube (double lumen)patients routinely use double lumen endotracheal intubation while they have received thoracoscopy | Device | intubated |
| nonintubatedpatients receiving nonintubated anesthetic plan while they have received thoracoscopy | Device | nonintubated |
Primary outcome
impedance changes
Time frame: average 4 hours
using esophageal manometry to evaluate the swallowing
2 secondary outcomes
esophageal pressure changes
Time frame: average 4 hours
hyoid bone distance
Time frame: average 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ya-Jung Cheng, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endotracheal tube (double lumen) and nonintubated in people with Esophageal Function in Thoracoscopy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya-Jung Cheng, MD (+886-972651609, chengyj@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
impedance changes (time frame: average 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.