Nonintubated Versus Intubated Anesthesia in Video-assisted Thoracic Surgery

NCT04253795 | Suspended

• 1 other identifier: AntalyaTRH030
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Anesthesia time

  20 minutes

• Operating room time

  1 hour

• Post anesthetic care unit (PACU) time

  30 minutes

• Surgeon satisfaction

  10 minutes

• Patient satisfaction

  10 minutes

Study Arms (2)

Laryngeal mask group (Group 1)

ACTIVE COMPARATOR

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

Double lumen tube Group (Group 2)

ACTIVE COMPARATOR

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

Interventions

Laryngeal mask OTHER

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.

Laryngeal mask group (Group 1)

double lumen tube OTHER

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

Double lumen tube Group (Group 2)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Antalya Training and Reseach Hospital Department of Anesthesiology and Reanimation

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Ali Sait Kavakli, M.D.

  Antalya Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Tayfun Sugur, M.D.

  Antalya Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: February 5, 2020
• Study Start: September 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2021
• Last Updated: April 30, 2020

Record last verified: 2020-04

Locations

TU (1)