Nonintubated Versus Intubated Anesthesia in Video-assisted Thoracic Surgery

Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04253795
• Other study ID #: AntalyaTRH030
• Status: Suspended
• Phase: N/A
• Start date: September 2020
• Est. completion date: February 2021

Study information

• Verified date: April 2020
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: February 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation

Intervention

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.
• double lumen tube
After the one lung ventilation will be started, lung isolation will be achieved by deflation of the nondependent lung.

Locations

Country	Name	City	State
Turkey	Antalya Training and Reseach Hospital Department of Anesthesiology and Reanimation	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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