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Nonintubated Versus Intubated Anesthesia in Video-assisted Thoracic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253795
Recruitment Status : Suspended (not recruiting, awaiting for changes in IRB)
First Posted : February 5, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Antalya Training and Research Hospital

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).

Condition or disease Intervention/treatment Phase
Intubation Other: Laryngeal mask Other: double lumen tube Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparative Study of Nonintubated Anesthesia With Laryngeal Mask Versus Intubated Anesthesia With Double Lumen Tube in Video-assisted Thoracic Surgery
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021

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.




Primary Outcome Measures :
  1. difference in PaO2/FiO2 ratio at the end of the surgery [ Time Frame: 1 hour ]
    PaO2/FiO2 ratio will be calculated for both groups at the end of the surgery


Secondary Outcome Measures :
  1. Anesthesia time [ Time Frame: 20 minutes ]
    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

  2. Operating room time [ Time Frame: 1 hour ]
    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.

  3. Post anesthetic care unit (PACU) time [ Time Frame: 30 minutes ]
    PACU time will be defined in minute as the time from arrival to the PACU until the patient was discharged to the ward.

  4. Surgeon satisfaction [ Time Frame: 10 minutes ]
    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").

  5. Patient satisfaction [ Time Frame: 10 minutes ]
    Patient will be asked to rate his satisfaction using a 4-point Likert scale (ie, "4: excellent", "3: good", "2: satisfactory", "1: unsatisfactory").



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253795


Locations
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Turkey
Antalya Training and Reseach Hospital Department of Anesthesiology and Reanimation
Antalya, Turkey
Sponsors and Collaborators
Antalya Training and Research Hospital
Investigators
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Principal Investigator: Ali Sait Kavakli, M.D. Antalya Training and Research Hospital
Study Director: Tayfun Sugur, M.D. Antalya Training and Research Hospital
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Responsible Party: Antalya Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04253795    
Other Study ID Numbers: AntalyaTRH030
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No