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

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

Study Overview

• Status: Recruiting
• Conditions: Esophageal Function in Thoracoscopy
• Intervention / Treatment: Device: nonintubated; Device: endotracheal tube (double lumen)

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 Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ya-Jung Cheng, MD; Phone Number: +886-972651609; Email: chengyj@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 10002
    • Recruiting
    • Ya-Jung Cheng
    • Contact: Ya-Jung Cheng, MD; Phone Number: 0223123456; Email: chengyj@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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
2. Aged from 20-80 years old

Exclusion Criteria:

1. Major systemic disease, such as congestive heart failure, liver cirrhosis, and end stage renal disease.
2. Patients who have the risk of difficult ventilation or intubation.
3. pregnant women
4. coagulopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: nonintubated; patients received nonintubated during thoracoscopy	Device: nonintubated; patients receiving nonintubated anesthetic plan while they have received thoracoscopy
Experimental: intubated; patients receiving intubated during thoracoscopy	Device: endotracheal tube (double lumen); patients routinely use double lumen endotracheal intubation while they have received thoracoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
impedance changes	using esophageal manometry to evaluate the swallowing	average 4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
esophageal pressure changes	using esophageal manometry to evaluate the swallowing	average 4 hours
hyoid bone distance	using ultrasound to evaluate the swallowing	average 4 hours

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Ya-Jung Cheng, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2018
• Primary Completion (Anticipated): October 25, 2020
• Study Completion (Anticipated): October 25, 2023

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 16, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 201804093RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No