IntubationNCT04253795
Nonintubated Versus Intubated Anesthesia in Video-assisted Thoracic Surgery
A study testing Laryngeal mask and double lumen tube in people with Intubation, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intubation
- What is being tested?
- Laryngeal mask and double lumen tube
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2020to Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective minor VATS procedures will be enrolled the study
Who cannot join
- 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)
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- atrioventricular block,
- hepatic or renal dysfunction,
- coagulopathy,
- asthma
- sleep apnea syndrome
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Reseach Hospital Department of Anesthesiology and Reanimation
Antalya
About this study
Official title: Comparative Study of Nonintubated Anesthesia With Laryngeal Mask Versus Intubated Anesthesia With Double Lumen Tube in Video-assisted Thoracic Surgery
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).
Read the 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.
- Conditions
- Intubation
- Being tested
- Laryngeal mask, double lumen tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal maskOther
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 tubeOther
After the one lung ventilation will be started, lung isolation will be achieved by deflation of the nondependent lung.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: double lumen tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour
Secondary outcomes (5)
Anesthesia time
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
Measured: 20 minutes
Operating room time
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.
Measured: 1 hour
Post anesthetic care unit (PACU) time
PACU time will be defined in minute as the time from arrival to the PACU until the patient was discharged to the ward.
Measured: 30 minutes
Surgeon satisfaction
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").
Measured: 10 minutes
Patient satisfaction
Patient will be asked to rate his satisfaction using a 4-point Likert scale (ie, "4: excellent", "3: good", "2: satisfactory", "1: unsatisfactory").
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study startSep 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionFeb 2021 (estimated)
Why it stopped: not recruiting, awaiting for changes in IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ali Sait Kavakli, M.D., Principal investigator, Antalya Training and Research HospitalTayfun Sugur, M.D., Study director, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253795
- Sponsor's protocol ID
- AntalyaTRH030
- Status last verified
- Apr 2020
- First submitted
- 23 Jan 2020
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Nonintubated Anesthesia With Laryngeal Mask Versus Intubated Anesthesia With Double Lumen Tube in Video-assisted Thoracic Surgery
- ClinicalTrials.gov ID
- NCT04253795
- Acronym / sponsor ID
- AntalyaTRH030
- Conditions
- Intubation
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: not recruiting, awaiting for changes in IRB
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- Sep 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laryngeal mask group (Group 1) | Active comparator | Other: Laryngeal maskLaryngeal 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 |
| Double lumen tube Group (Group 2) | Active comparator | Other: double lumen tubeAfter 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective minor VATS procedures will be enrolled the study
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laryngeal maskAfter 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 | Laryngeal mask group (Group 1) |
| double lumen tubeAfter the one lung ventilation will be started, lung isolation will be achieved by deflation of the nondependent lung. | Other | Double lumen tube Group (Group 2) |
Primary outcome
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
5 secondary outcomes
Anesthesia time
Time frame: 20 minutes
Operating room time
Time frame: 1 hour
Post anesthetic care unit (PACU) time
Time frame: 30 minutes
Surgeon satisfaction
Time frame: 10 minutes
Patient satisfaction
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Sait Kavakli, M.D. principal investigator
Antalya Training and Research Hospital
Tayfun Sugur, M.D. study director
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal mask and double lumen tube in people with Intubation, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in PaO2/FiO2 ratio at the end of the surgery (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.