Nonintubated Versus Intubated Anesthesia in Video-assisted Thoracic Surgery

Comparative Study of Nonintubated Anesthesia With Laryngeal Mask Versus Intubated Anesthesia With Double Lumen Tube in Video-assisted Thoracic Surgery

The purpose of this study is to compare to the patients undergoing nonintubated general anesthesia with laryngeal mask and undergoing intubated general anesthesia with double-lumen endotracheal intubation in Video-assisted thoracic surgery (VATS).

Study Overview

• Status: Suspended
• Conditions: Intubation
• Intervention / Treatment: Other: Laryngeal mask; Other: double lumen tube

Detailed Description

Although general anesthesia with double-lumen intubation is generally mandatory for Video-assisted thoracic surgery procedures intubation with double lumen tube is related to several risks. Nonintubated general anesthesia with laryngeal mask in patients with spontaneous breathing may be an alternative choice for minor VATS procedures.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey
    • Antalya Training and Reseach Hospital Department of Anesthesiology and Reanimation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing elective minor VATS procedures will be enrolled the study

Exclusion Criteria:

• patients <18 years old,
• body mass index (BMI)>30 kg/m2,
• American Society Association (ASA) Class>3,
• heart failure (New York Heart Association class > II),
• a history of arrhythmia or treatment with antiarrhythmic drugs,
• bradycardia (heart rate (HR) <45 beats min1)
• atrioventricular block,
• hepatic or renal dysfunction,
• coagulopathy,
• asthma
• sleep apnea syndrome

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laryngeal mask group (Group 1); Laryngeal mask will be placed in the airway by the anesthesiologist. Lung isolation will be achieved with an artificial pneumothorax induced during opening the pleura, which resulted to the collapse of the nondependent lung with the patient's spontaneous breathing	Other: Laryngeal mask; After the laryngeal mask will be inserted lung isolation will be achieved with an artificial pneumothorax induced during opening the pleura, which resulted to the collapse of the nondependent lung with the patient's spontaneous breathing.
Active Comparator: Double lumen tube Group (Group 2); After the correct position of double lumen tube will be determined, one lung ventilation will be started. Lung isolation will be achieved by deflation of the nondependent lung.	Other: double lumen tube; After the one lung ventilation will be started, lung isolation will be achieved by deflation of the nondependent lung.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference in PaO2/FiO2 ratio at the end of the surgery	PaO2/FiO2 ratio will be calculated for both groups at the end of the surgery	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthesia time	Anesthesia time will be defined in minute as the time from starting electronically monitored in the operating room until the time the double lumen tube or laryngeal mask was correctly placed	20 minutes
Operating room time	Operating room time will be defined in minute as the time from arrival to operating room until the patient will be transferred to the post anesthetic care unit.	1 hour
Post anesthetic care unit (PACU) time	PACU time will be defined in minute as the time from arrival to the PACU until the patient was discharged to the ward.	30 minutes
Surgeon satisfaction	Surgeon will be asked to rate his satisfaction with the surgical conditions using a 4-point Likert scale (ie, "4: excellent", "3: good", "2: satisfactory", "1: unsatisfactory").	10 minutes
Patient satisfaction	Patient will be asked to rate his satisfaction using a 4-point Likert scale (ie, "4: excellent", "3: good", "2: satisfactory", "1: unsatisfactory").	10 minutes

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital
• Investigators: Study Director: Tayfun Sugur, M.D., Antalya Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: February 1, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: AntalyaTRH030

Drug and device information, study documents

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