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Nonintubated Versus Intubated Anesthesia in Video-assisted Thoracic Surgery

NCT ID: NCT04253795

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2021-02-28

Brief Summary

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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

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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.

Conditions

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Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Laryngeal mask

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

double lumen tube

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

double lumen tube

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ali Sait Kavakli, M.D.

Role: PRINCIPAL_INVESTIGATOR

Antalya Training and Research Hospital

Tayfun Sugur, M.D.

Role: STUDY_DIRECTOR

Antalya Training and Research Hospital

Locations

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Antalya Training and Reseach Hospital Department of Anesthesiology and Reanimation

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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AntalyaTRH030

Identifier Type: -

Identifier Source: org_study_id