Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE January 23, 2020
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date April 30, 2020
Estimated Study Start Date  ICMJE September 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2020)
  • 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
  • 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.
  • 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.
  • 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").
  • 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").
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nonintubated Versus Intubated Anesthesia in Video-assisted Thoracic Surgery
Official Title  ICMJE Comparative Study of Nonintubated Anesthesia With Laryngeal Mask Versus Intubated Anesthesia With Double Lumen Tube in Video-assisted Thoracic Surgery
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Intubation
Intervention  ICMJE
  • 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.
  • Other: double lumen tube
    After the one lung ventilation will be started, lung isolation will be achieved by deflation of the nondependent lung.
Study Arms  ICMJE
  • 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
    Intervention: Other: Laryngeal mask
  • 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.
    Intervention: Other: double lumen tube
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: February 1, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04253795
Other Study ID Numbers  ICMJE AntalyaTRH030
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Antalya Training and Research Hospital
Study Sponsor  ICMJE Antalya Training and Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ali Sait Kavakli, M.D. Antalya Training and Research Hospital
Study Director: Tayfun Sugur, M.D. Antalya Training and Research Hospital
PRS Account Antalya Training and Research Hospital
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP