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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

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04253795
Enrollment
60
Registered
2020-02-05
Start date
2020-09-30
Completion date
2021-02-28
Last updated
2020-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation

Brief 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).

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.

Interventions

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.

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

Sponsors

Antalya Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
difference in PaO2/FiO2 ratio at the end of the surgery1 hourPaO2/FiO2 ratio will be calculated for both groups at the end of the surgery

Secondary

MeasureTime frameDescription
Anesthesia time20 minutesAnesthesia 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
Operating room time1 hourOperating 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.
Post anesthetic care unit (PACU) time30 minutesPACU time will be defined in minute as the time from arrival to the PACU until the patient was discharged to the ward.
Surgeon satisfaction10 minutesSurgeon 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).
Patient satisfaction10 minutesPatient will be asked to rate his satisfaction using a 4-point Likert scale (ie, 4: excellent, 3: good, 2: satisfactory, 1: unsatisfactory).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026