Lung CancerNCT03656406
Effect of Lateral Positioning on Bronchial Cuff Pressure of Left-sided Double-lumen Endotracheal Tube During Thoracic Surgery
An observational study of Lung Cancer and Pneumothorax, run by Daegu Catholic University Medical Center at 1 site in South Korea.
Trial summary
The investigators evaluate the effect of postural change on the bronchial cuff pressure (BCP) of double-lumen endotracheal tube (DLT) in patients undergoing thoracic surgery, by observing the pressure of the bronchial cuff before and after lateral decubitus positioning. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Pneumothorax
- What is being tested?
- Lateral decubitus positioning and Cuff-manometer
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2018to 30 Dec 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18-70 years with an American Society of Anesthesiologists (ASA) physical status 1 or 2, who are scheduled to undergo elective lung surgery requiring lateral decubitus positioning and one-lung ventilation (OLV) using left-sided DLT
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status 1 or 2
- Elective lung surgery requiring lateral decubitus positioning and one-lung ventilation using left-sided DLT
Who cannot join
- Patients requiring a right-sided DLT.
- Patients with an intraluminal lesion in the left mainstem bronchus (LMB).
- Patients with an anatomical problem in the tracheobronchial tree.
- Patients with impaired lung such as chronic obstructive pulmonary disease.
- Patients who refused to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lateral Positioning on Bronchial Cuff Pressure of Left-sided Double-lumen Endotracheal Tube During Thoracic Surgery: a Prospective Observational Study
The investigators evaluate the effect of postural change on the bronchial cuff pressure (BCP) of double-lumen endotracheal tube (DLT) in patients undergoing thoracic surgery, by observing the pressure of the bronchial cuff before and after lateral decubitus positioning.
Read the detailed description
It is essential to maintain proper cuff pressure in the endotracheal tube (ETT) when placing the ETT in the trachea in patients undergoing general anesthesia. Most of the literature recommend maintaining a pressure of 20-30 cmH2O to prevent cuff-related complications such as micro-aspiration or airway trauma. Proper pressure is also important for DLTs used in thoracic surgery. Furthermore, the cuff pressure of the ETT can change during the patient's positional changes. All things considered, we hypothesized that the change from supine to lateral decubitus position, which is essential for thoracic surgery would affect the BCP of the DLT.
- Conditions
- Lung Cancer, Pneumothorax
- Being tested
- Lateral decubitus positioning, Cuff-manometer
- Keywords
- Double-lumen endotracheal tube, Cuff pressure
- Medical subject headings
- Lung Neoplasms, Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral decubitus positioningBehavioural
After the DLT intubation, the patient is placed in lateral decubitus position
Cuff-manometerDevice
The pressure of the bronchial cuff should be measured with cuff-manometer in supine position, and then measurement should be repeated after lateral positioning.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the maximum bronchial cuff pressure (BCP) which does not exceed 40 cmH2O with no air leak from supine to lateral decubitus position
A cuff-manometer will be connected to the valve of the pilot balloon of bronchial cuff via a three-way stopcock. And then, the BCP will be assessed, while inflating the cuff with air in 0.5 ml increments from 0 to 3.0 ml. If the BCP exceeds 40 cmH2O during expansion by increasing 0.5 ml from 0 to 3.0 ml, we will stop inflating the bronchial cuff with air and record the bronchial cuff volume (BCV) and BCP up to the last numerical value. During the pressure measurement, air leak or seal around the bronchial cuff will be assessed at each time point when inflating the cuff in 0.5 ml increments.
Measured: 1. In supine position, 2 minutes after the completion of confirming the double-lumen endotracheal tube (DLT) position via fiberoptic bronchoscope (FOB) 2. In lateral position, 2 minutes after the completion of confirming the DLT position via FOB
Secondary outcomes (2)
The incidence of the patients whose maximum BCP exceed 40 cmH2O after lateral positioning
Measured: 1. In supine position, 2 minutes after the completion of confirming the DLT position via FOB 2. In lateral position, 2 minutes after the completion of confirming the DLT position via FOB
The minimum BCV that is the smallest bronchial cuff volume without air leakage
Measured: 1. In supine position, 2 minutes after the completion of confirming the DLT position via FOB 2. In lateral position, 2 minutes after the completion of confirming the DLT position via FOB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start1 Sep 2018
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daegu Catholic University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Research Institute of Medical Science, Daegu Catholic University
- Responsible party
- Principal investigator, Sung Hye Byun, Daegu Catholic University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656406
- Sponsor's protocol ID
- CR-18-111
- Status last verified
- Aug 2020
- First submitted
- 30 Aug 2018
- Last updated
- 6 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu CY, Yeh YC, Wang MC, Lai CH, Fan SZ. Changes in endotracheal tube cuff pressure during laparoscopic surgery in head-up or head-down position. BMC Anesthesiol. 2014 Aug 31;14:75. doi: 10.1186/1471-2253-14-75. eCollection 2014.
PubMed 25210501Athiraman U, Gupta R, Singh G. Endotracheal cuff pressure changes with change in position in neurosurgical patients. Int J Crit Illn Inj Sci. 2015 Oct-Dec;5(4):237-41. doi: 10.4103/2229-5151.170841.
PubMed 26807392Araki K, Nomura R, Urushibara R, Yoshikawa Y, Hatano Y. Bronchial cuff pressure change caused by left-sided double-lumen endobronchial tube displacement. Can J Anaesth. 2000 Aug;47(8):775-9. doi: 10.1007/BF03019480.
PubMed 10958094Kim E, Kim IY, Byun SH. Effect of lateral positioning on the bronchial cuff pressure of a left-sided double-lumen endotracheal tube during thoracic surgery: study protocol for a prospective observational study. BMJ Open. 2019 Mar 30;9(3):e026606. doi: 10.1136/bmjopen-2018-026606.
PubMed 30928955
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lateral Positioning on Bronchial Cuff Pressure of Left-sided Double-lumen Endotracheal Tube During Thoracic Surgery: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03656406
- Acronym / sponsor ID
- CR-18-111
- Conditions
- Lung Cancer, Pneumothorax
- Keywords
- Double-lumen endotracheal tube, Cuff pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Daegu Catholic University Medical CenterUniversity, hospital or other
- Collaborators
- Research Institute of Medical Science, Daegu Catholic University
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 4 Sep 2018 (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 investigators evaluate the effect of postural change on the bronchial cuff pressure (BCP) of double-lumen endotracheal tube (DLT) in patients undergoing thoracic surgery, by observing the pressure of the bronchial cuff before and after lateral decubitus positioning.
Detailed description
It is essential to maintain proper cuff pressure in the endotracheal tube (ETT) when placing the ETT in the trachea in patients undergoing general anesthesia. Most of the literature recommend maintaining a pressure of 20-30 cmH2O to prevent cuff-related complications such as micro-aspiration or airway trauma. Proper pressure is also important for DLTs used in thoracic surgery. Furthermore, the cuff pressure of the ETT can change during the patient's positional changes. All things considered, we hypothesized that the change from supine to lateral decubitus position, which is essential for thoracic surgery would affect the BCP of the DLT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-70 years with an American Society of Anesthesiologists (ASA) physical status 1 or 2, who are scheduled to undergo elective lung surgery requiring lateral decubitus positioning and one-lung ventilation (OLV) using left-sided DLT
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status 1 or 2
- Elective lung surgery requiring lateral decubitus positioning and one-lung ventilation using left-sided DLT
Key exclusion criteria (5 listed)
- Patients requiring a right-sided DLT.
- Patients with an intraluminal lesion in the left mainstem bronchus (LMB).
- Patients with an anatomical problem in the tracheobronchial tree.
- Patients with impaired lung such as chronic obstructive pulmonary disease.
- Patients who refused to participate in this study.
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 |
|---|---|---|
| Lateral decubitus positioningAfter the DLT intubation, the patient is placed in lateral decubitus position | Behavioural | – |
| Cuff-manometerThe pressure of the bronchial cuff should be measured with cuff-manometer in supine position, and then measurement should be repeated after lateral positioning. | Device | – |
Primary outcome
Change of the maximum bronchial cuff pressure (BCP) which does not exceed 40 cmH2O with no air leak from supine to lateral decubitus position
Time frame: 1. In supine position, 2 minutes after the completion of confirming the double-lumen endotracheal tube (DLT) position via fiberoptic bronchoscope (FOB) 2. In lateral position, 2 minutes after the completion of confirming the DLT position via FOB
A cuff-manometer will be connected to the valve of the pilot balloon of bronchial cuff via a three-way stopcock. And then, the BCP will be assessed, while inflating the cuff with air in 0.5 ml increments from 0 to 3.0 ml. If the BCP exceeds 40 cmH2O during expansion by increasing 0.5 ml from 0 to 3.0 ml, we will stop inflating the bronchial cuff with air and record the bronchial cuff volume (BCV) and BCP up to the last numerical value. During the pressure measurement, air leak or seal around the bronchial cuff will be assessed at each time point when inflating the cuff in 0.5 ml increments.
2 secondary outcomes
The incidence of the patients whose maximum BCP exceed 40 cmH2O after lateral positioning
Time frame: 1. In supine position, 2 minutes after the completion of confirming the DLT position via FOB 2. In lateral position, 2 minutes after the completion of confirming the DLT position via FOB
The minimum BCV that is the smallest bronchial cuff volume without air leakage
Time frame: 1. In supine position, 2 minutes after the completion of confirming the DLT position via FOB 2. In lateral position, 2 minutes after the completion of confirming the DLT position via FOB
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 6 Aug 2020.
- Background: PubMed 25210501Wu CY, Yeh YC, Wang MC, Lai CH, Fan SZ. Changes in endotracheal tube cuff pressure during laparoscopic surgery in head-up or head-down position. BMC Anesthesiol. 2014 Aug 31;14:75. doi: 10.1186/1471-2253-14-75. eCollection 2014.
- Background: PubMed 26807392Athiraman U, Gupta R, Singh G. Endotracheal cuff pressure changes with change in position in neurosurgical patients. Int J Crit Illn Inj Sci. 2015 Oct-Dec;5(4):237-41. doi: 10.4103/2229-5151.170841.
- Background: PubMed 10958094Araki K, Nomura R, Urushibara R, Yoshikawa Y, Hatano Y. Bronchial cuff pressure change caused by left-sided double-lumen endobronchial tube displacement. Can J Anaesth. 2000 Aug;47(8):775-9. doi: 10.1007/BF03019480.
- Derived from this study: PubMed 30928955Kim E, Kim IY, Byun SH. Effect of lateral positioning on the bronchial cuff pressure of a left-sided double-lumen endotracheal tube during thoracic surgery: study protocol for a prospective observational study. BMJ Open. 2019 Mar 30;9(3):e026606. doi: 10.1136/bmjopen-2018-026606.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lung Cancer and Pneumothorax, run by Daegu Catholic University Medical Center at 1 site in South Korea.
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 5 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 6 Aug 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 South Korea. 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?
Change of the maximum bronchial cuff pressure (BCP) which does not exceed 40 cmH2O with no air leak from supine to lateral decubitus position (time frame: 1. In supine position, 2 minutes after the completion of confirming the double-lumen endotracheal tube (DLT) position via fiberoptic bronchoscope (FOB) 2. In lateral position, 2 minutes after the completion of confirming the DLT position via FOB). 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 NCT03656406, which also lists 4 linked publications.
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 6 Aug 2020.