One Lung VentilationNCT06064773
Evaluation Of One Lung Ventilation With Ultrasound in Thorax Surgery Operations
An observational study of One Lung Ventilation, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
BACKGROUND: The aim of this study is to evaluate the confirmation of double lumen tube placement with thoracic Ultrasound (USG) in thorax surgery operations with one lung ventilation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- One Lung Ventilation
- What is being tested?
- thoracic USG
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 1 Dec 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Over 18 years old, patients who need OLV and undergoing elective surgery
Who may be able to join
- Over 18 years old, patients
- who need OLV and undergoing elective surgery
Who cannot join
- patients did not want to participate in the study,
- with a narrowed trachea and/or a narrowed main bronchus
- with endobronchial lesion in the main bronchus,
- with subcutaneous emphysema,
- having a chest tube due to pneumothorax,
- with pleural effusion,
Show all 10Show fewer
- having a history of pleurodesis,
- bullous lung,
- patients with a history of tracheostomy
- patients who will undergo emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
BACKGROUND: The aim of this study is to evaluate the confirmation of double lumen tube placement with thoracic Ultrasound (USG) in thorax surgery operations with one lung ventilation.
METHODS: In this prospective and observational study, 130 patients aged between 18-65 years in ASA (American Society of Anesthesiology) I-III risk class who will undergo thoracic surgery with the application of single-lung ventilation were included in the study. A double-lumen endobronchial tube was placed in the patients blindly. One-lung ventilation (OLV) was confirmed by thoracic USG by the anesthesiologist. The patient's demographic data, rapid clinical evaluation and USG data results, and intraoperative surgeon satisfaction were recorded.
Read the detailed description
This prospective observational study was carried out in the Department of Anesthesiology and Reanimation, with the permission of the Ethics Committee of Dokuz Eylul University Medical Faculty Hospital (Ethics Committee Decision No:2021/17-04). Between 01.07.2021 and 01.12.2021, cases requiring single-lung ventilation by thoracic surgery in the operating room of Dokuz Eylul University Faculty of Medicine were included in the study.
Over 18 years old, patients who need OLV and undergoing elective surgery was determined as inclusion criteria. Furthermore patients did not want to participate in the study, with a narrowed trachea and/or a narrowed main bronchus that does not allow DLT placement, with endobronchial lesion in the main bronchus, with subcutaneous emphysema, having a chest tube due to pneumothorax, with pleural effusion, having a history of pleurodesis, bullous lung, patients with a history of tracheostomy and patients who will undergo emergency surgery determined as exclusion criteria for the study.
On the day of surgery, all patients were premedicated after a 20 G cannula was placed on the back of the hand before they were taken to the operating room. Routine anesthesia induction was performed after preoxygenation with 100% O2 for 5 minutes by monitoring 3-lead electrocardiography, peripheral oxygen saturation and noninvasive blood pressure in the patients who were taken to the operating room. After anesthesia induction, patients underwent double lumen tube intubation and after confirming single lung ventilation with thoracic USG (GE Healthcare LOGIQ e), tube location was confirmed by fiberoptic bronchoscopy (FOB) and clinical evaluation and recorded. Slip sign on USG was evaluated with M-mode imaging in the right and left lower quadrants of the thorax at the level of the costophrenic angles. When the bronchial lumen was clamped, the tube was considered to be positioned correctly if the left shift sign was selectively lost.
Age, gender, body mass index (BMI), AmericanSociety of Anesthesiologists score, co-morbidities (Hypertension, diabetes mellitus, malignancy, chronic obstructive pulmonary disease) duration of surgery, clinical and FOB evaluation results of the patients included in the study, in the supine position and in the lateral position during the intraoperative period. The determined DLT malpositions and the manipulations performed to correct them and the results of the evaluation with the thorax USG method, as well as the intraoperative surgeon satisfaction were recorded by the doctor who followed the case.
- Conditions
- One Lung Ventilation
- Being tested
- thoracic USG
- Keywords
- One Lung Ventilation, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic USGDiagnostic test
the confirmation of double lumen tube placement with thoracic USG in thoracic surgery operations with one lung ventilation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracic USG sensitive and specificity values
confirmation of DLT location with thorax USG in thoracic surgery operations in which Single Lung ventilation was applied, sensitive and specificity values
Measured: immediatelay after the Replacement of double lumen ETT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Jul 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for One Lung VentilationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hale Aksu, Dokuz Eylul University
- Investigators
- Hale Aksu, Principal investigator, Associated prof
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064773
- Sponsor's protocol ID
- 2021/17-04
- Status last verified
- Sep 2023
- First submitted
- 19 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If researchers ask for share then will be decided
Publications
Kanavitoon S, Raksamani K, Troy MP, Suphathamwit A, Thongcharoen P, Suksompong S, Oh SS. Lung ultrasound is non-inferior to bronchoscopy for confirmation of double-lumen endotracheal tube positioning: a randomized controlled noninferiority study. BMC Anesthesiol. 2022 May 30;22(1):168. doi: 10.1186/s12871-022-01707-4.
PubMed 35637457
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of One Lung Ventilation With Ultrasound in Thorax Surgery Operations
- ClinicalTrials.gov ID
- NCT06064773
- Acronym / sponsor ID
- 2021/17-04
- Conditions
- One Lung Ventilation
- Keywords
- One Lung Ventilation, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 3 Oct 2023 (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.
BACKGROUND: The aim of this study is to evaluate the confirmation of double lumen tube placement with thoracic Ultrasound (USG) in thorax surgery operations with one lung ventilation.
METHODS: In this prospective and observational study, 130 patients aged between 18-65 years in ASA (American Society of Anesthesiology) I-III risk class who will undergo thoracic surgery with the application of single-lung ventilation were included in the study. A double-lumen endobronchial tube was placed in the patients blindly. One-lung ventilation (OLV) was confirmed by thoracic USG by the anesthesiologist. The patient's demographic data, rapid clinical evaluation and USG data results, and intraoperative surgeon satisfaction were recorded.
Detailed description
This prospective observational study was carried out in the Department of Anesthesiology and Reanimation, with the permission of the Ethics Committee of Dokuz Eylul University Medical Faculty Hospital (Ethics Committee Decision No:2021/17-04). Between 01.07.2021 and 01.12.2021, cases requiring single-lung ventilation by thoracic surgery in the operating room of Dokuz Eylul University Faculty of Medicine were included in the study.
Over 18 years old, patients who need OLV and undergoing elective surgery was determined as inclusion criteria. Furthermore patients did not want to participate in the study, with a narrowed trachea and/or a narrowed main bronchus that does not allow DLT placement, with endobronchial lesion in the main bronchus, with subcutaneous emphysema, having a chest tube due to pneumothorax, with pleural effusion, having a history of pleurodesis, bullous lung, patients with a history of tracheostomy and patients who will undergo emergency surgery determined as exclusion criteria for the study.
On the day of surgery, all patients were premedicated after a 20 G cannula was placed on the back of the hand before they were taken to the operating room. Routine anesthesia induction was performed after preoxygenation with 100% O2 for 5 minutes by monitoring 3-lead electrocardiography, peripheral oxygen saturation and noninvasive blood pressure in the patients who were taken to the operating room. After anesthesia induction, patients underwent double lumen tube intubation and after confirming single lung ventilation with thoracic USG (GE Healthcare LOGIQ e), tube location was confirmed by fiberoptic bronchoscopy (FOB) and clinical evaluation and recorded. Slip sign on USG was evaluated with M-mode imaging in the right and left lower quadrants of the thorax at the level of the costophrenic angles. When the bronchial lumen was clamped, the tube was considered to be positioned correctly if the left shift sign was selectively lost.
Age, gender, body mass index (BMI), AmericanSociety of Anesthesiologists score, co-morbidities (Hypertension, diabetes mellitus, malignancy, chronic obstructive pulmonary disease) duration of surgery, clinical and FOB evaluation results of the patients included in the study, in the supine position and in the lateral position during the intraoperative period. The determined DLT malpositions and the manipulations performed to correct them and the results of the evaluation with the thorax USG method, as well as the intraoperative surgeon satisfaction were recorded by the doctor who followed the case.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Over 18 years old, patients who need OLV and undergoing elective surgery
Key inclusion criteria (2 listed)
- Over 18 years old, patients
- who need OLV and undergoing elective surgery
Key exclusion criteria (10 listed)
- patients did not want to participate in the study,
- with a narrowed trachea and/or a narrowed main bronchus
- with endobronchial lesion in the main bronchus,
- with subcutaneous emphysema,
- having a chest tube due to pneumothorax,
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 |
|---|---|---|
| thoracic USGthe confirmation of double lumen tube placement with thoracic USG in thoracic surgery operations with one lung ventilation. | Diagnostic test | – |
Primary outcome
Thoracic USG sensitive and specificity values
Time frame: immediatelay after the Replacement of double lumen ETT
confirmation of DLT location with thorax USG in thoracic surgery operations in which Single Lung ventilation was applied, sensitive and specificity values
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Results publication: PubMed 35637457Kanavitoon S, Raksamani K, Troy MP, Suphathamwit A, Thongcharoen P, Suksompong S, Oh SS. Lung ultrasound is non-inferior to bronchoscopy for confirmation of double-lumen endotracheal tube positioning: a randomized controlled noninferiority study. BMC Anesthesiol. 2022 May 30;22(1):168. doi: 10.1186/s12871-022-01707-4.
- Individual participant dataSharing planned: Undecided. If researchers ask for share then will be decided
Related trials for One Lung Ventilation
RecruitingObservational study
Frequency and Severity of Respiratory Acidosis During One-lung Ventilation, a Retrospective Pilot Study to Compare Clinician Settings and Those Proposed by the VentilO Application
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Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
Not yet recruiting
Flow-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Thoracic Surgery
Mechanical Ventilation, Postoperative Pulmonary Complications (PPCs)
Recruiting
BMI-Adjusted PEEP During One-Lung Ventilation in Thoracic Surgery
Pulmonary Resection Surgery, One Lung Ventillation (OLV)
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.
Hale Aksu principal investigator
Associated prof
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of One Lung Ventilation, run by Dokuz Eylul University 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 2 inclusion and 10 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: finished, as of the sponsor's last update on 3 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Thoracic USG sensitive and specificity values (time frame: immediatelay after the Replacement of double lumen ETT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06064773, which also lists 1 linked publication.
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 3 Oct 2023.