Thoracic SurgeryNCT00793936
Criteria for Choice of Right Double Lumen Tube (DLT)
An observational study of Thoracic Surgery, run by Assaf-Harofeh Medical Center.
Trial summary
There are specific guidelines for choice of Lt DLT size in correlation to patient's height and tracheal diameter on chest X-ray/CT scan. Accordingly to these criteria the RT DLT size is determined. Should the criteria for determining the appropriate size be the same for Rt and Lt DLT? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Dec 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: After obtaining informed consent, male and female patients over 18 years of age, candidates for elective thoracic surgery obliging DLT intubation, will be enrolled in the study. Children, pregnant and mentally incompetent patients will not be included.
Who may be able to join
- male and female patients over 18 years of age , candidates for elective thoracic surgery obliging DLT intubation, will be enrolled in the study
Who cannot join
- Children, pregnant and mentally incompetent patients will not be included
About this study
Official title: Criteria for Choice of Right Double Lumen Tube for Lung Surgery
There are specific guidelines for choice of Lt DLT size in correlation to patient's height and tracheal diameter on chest X-ray/CT scan. Accordingly to these criteria the RT DLT size is determined.
Should the criteria for determining the appropriate size be the same for Rt and Lt DLT?
Read the detailed description
Objective: Adequacy of criteria for Lt DLT size in the determination of RT DLT size before thoracic surgery.
Methods: A prospective, controlled, comparative study. After obtaining informed consent, male and female patients over 18 years of age , candidates for elective thoracic surgery obliging DLT intubation, will be enrolled in the study. Children, pregnant and mentally incompetent patients will not be included.
Preoperative evaluation will be performed by an anesthesiologist and the patients will receive premedication with respect to the planned operation and concurrent disease status. The age, gender, height and weight of the patient will be recorded. On the chest CT series, measurements of the tracheal length and diameter, both main bronchial, and RUL bronchial orifice diameter in millimeters will be performed, using an universal measurement system .
All patients will receive intravenous induction with Fentanyl 3-5 mcg/kg, Propofol 2-2.5 mg/kg, and Rocuronium 0.6-0.8 mg/kg. All patients will be intubated by the same anesthesiologist. Fiberoptic bronchoscopy will be performed for proper positioning of the DLT.
Accordingly to the indication , patients will be intubated with Lt or Rt DLT -Mallinkrodt Broncho-cath, routinely used for this kind of operations.
Patients scheduled for right lung operation will be intubated with Lt DLT. The size of the Lt DLT will be determined accordingly to the guidelines, in correlation with patient's height and CT measurements . Lt DLT intubation will be performed by the generally accepted technique, under FOB control. In case the Lt DLT size will prove to be inappropriate , a smaller/larger DLT will be inserted, accordingly.
Patients scheduled for left lung operation will be intubated with Rt DLT. The size of the Rt DLT will be determined in correlation with patient's height and CT measurements, accordingly to the guidelines for Lt DLT size . In case the Rt DLT positioning is impossible due to inappropriate adjustment of the ventilation slot against the RUL bronchus orifice and/or tracheal protrusion of the bronchial cuff, the Rt DLT will be substituted by a smaller/larger Rt DLT , respectively.
The number of attempts on intubation and repositionings of the DLT during surgery will be recorded.
The volume of air in the bronchial and tracheal cuff will be recorded. Information about the adequacy of lung separation will be obtained by the surgeons.
Postoperative clinical and X-ray follow up will be performed about lung recruitment and ventilatory complications ( atelectasis, pneumonia) Throughout the study no additional x-ray or laboratory checkup will be required, and no additional invasive procedures or treatment will be performed, than the usually accepted.
Statistical analysis of collected clinical and rentgenologic data will be performed .
- Conditions
- Thoracic Surgery
- Keywords
- Right Double Lumen Tube
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionAug 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Thoracic SurgeryStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793936
- Sponsor's protocol ID
- 160.08
- Status last verified
- Nov 2008
- First submitted
- 18 Nov 2008
- Last updated
- 19 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Campos JH, Massa FC, Kernstine KH. The incidence of right upper-lobe collapse when comparing a right-sided double-lumen tube versus a modified left double-lumen tube for left-sided thoracic surgery. Anesth Analg. 2000 Mar;90(3):535-40. doi: 10.1097/00000539-200003000-00007.
PubMed 10702432Chow MY, Liam BL, Lew TW, Chelliah RY, Ong BC. Predicting the size of a double-lumen endobronchial tube based on tracheal diameter. Anesth Analg. 1998 Jul;87(1):158-60. doi: 10.1097/00000539-199807000-00033.
PubMed 9661566Benumof JL, Partridge BL, Salvatierra C, Keating J. Margin of safety in positioning modern double-lumen endotracheal tubes. Anesthesiology. 1987 Nov;67(5):729-38. doi: 10.1097/00000542-198711000-00018.
PubMed 3674473Klein U, Karzai W, Bloos F, Wohlfarth M, Gottschall R, Fritz H, Gugel M, Seifert A. Role of fiberoptic bronchoscopy in conjunction with the use of double-lumen tubes for thoracic anesthesia: a prospective study. Anesthesiology. 1998 Feb;88(2):346-50. doi: 10.1097/00000542-199802000-00012.
PubMed 9477054Chow MY, Liam BL, Thng CH, Chong BK. Predicting the size of a double-lumen endobronchial tube using computed tomographic scan measurements of the left main bronchus diameter. Anesth Analg. 1999 Feb;88(2):302-5. doi: 10.1097/00000539-199902000-00014.
PubMed 9972745Amar D, Desiderio DP, Heerdt PM, Kolker AC, Zhang H, Thaler HT. Practice patterns in choice of left double-lumen tube size for thoracic surgery. Anesth Analg. 2008 Feb;106(2):379-83, table of contents. doi: 10.1213/ane.0b013e3181602e41.
PubMed 18227288Bussieres JS, Lacasse Y, Cote D, Beauvais M, St-Onge S, Lemieux J, Soucy J. Modified right-sided Broncho-Cath double lumen tube improves endobronchial positioning: a randomized study. Can J Anaesth. 2007 Apr;54(4):276-82. doi: 10.1007/BF03022772.
PubMed 17400979Eberle B, Weiler N, Vogel N, Kauczor HU, Heinrichs W. Computed tomography-based tracheobronchial image reconstruction allows selection of the individually appropriate double-lumen tube size. J Cardiothorac Vasc Anesth. 1999 Oct;13(5):532-7. doi: 10.1016/s1053-0770(99)90003-4.
PubMed 10527220Hannallah M, Benumof JL, Silverman PM, Kelly LC, Lea D. Evaluation of an approach to choosing a left double-lumen tube size based on chest computed tomographic scan measurement of left mainstem bronchial diameter. J Cardiothorac Vasc Anesth. 1997 Apr;11(2):168-71. doi: 10.1016/s1053-0770(97)90208-1.
PubMed 9105987Neustein SM. What is the best choice for size of double lumen tube? Anesth Analg. 2008 Jul;107(1):342-3. doi: 10.1213/ane.0b013e318173e773. No abstract available.
PubMed 18635507
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Criteria for Choice of Right Double Lumen Tube for Lung Surgery
- ClinicalTrials.gov ID
- NCT00793936
- Acronym / sponsor ID
- 160.08
- Conditions
- Thoracic Surgery
- Keywords
- Right Double Lumen Tube
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Nov 2008
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 19 Nov 2008 (estimated)
- 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.
There are specific guidelines for choice of Lt DLT size in correlation to patient's height and tracheal diameter on chest X-ray/CT scan. Accordingly to these criteria the RT DLT size is determined.
Should the criteria for determining the appropriate size be the same for Rt and Lt DLT?
Detailed description
Objective: Adequacy of criteria for Lt DLT size in the determination of RT DLT size before thoracic surgery.
Methods: A prospective, controlled, comparative study. After obtaining informed consent, male and female patients over 18 years of age , candidates for elective thoracic surgery obliging DLT intubation, will be enrolled in the study. Children, pregnant and mentally incompetent patients will not be included.
Preoperative evaluation will be performed by an anesthesiologist and the patients will receive premedication with respect to the planned operation and concurrent disease status. The age, gender, height and weight of the patient will be recorded. On the chest CT series, measurements of the tracheal length and diameter, both main bronchial, and RUL bronchial orifice diameter in millimeters will be performed, using an universal measurement system .
All patients will receive intravenous induction with Fentanyl 3-5 mcg/kg, Propofol 2-2.5 mg/kg, and Rocuronium 0.6-0.8 mg/kg. All patients will be intubated by the same anesthesiologist. Fiberoptic bronchoscopy will be performed for proper positioning of the DLT.
Accordingly to the indication , patients will be intubated with Lt or Rt DLT -Mallinkrodt Broncho-cath, routinely used for this kind of operations.
Patients scheduled for right lung operation will be intubated with Lt DLT. The size of the Lt DLT will be determined accordingly to the guidelines, in correlation with patient's height and CT measurements . Lt DLT intubation will be performed by the generally accepted technique, under FOB control. In case the Lt DLT size will prove to be inappropriate , a smaller/larger DLT will be inserted, accordingly.
Patients scheduled for left lung operation will be intubated with Rt DLT. The size of the Rt DLT will be determined in correlation with patient's height and CT measurements, accordingly to the guidelines for Lt DLT size . In case the Rt DLT positioning is impossible due to inappropriate adjustment of the ventilation slot against the RUL bronchus orifice and/or tracheal protrusion of the bronchial cuff, the Rt DLT will be substituted by a smaller/larger Rt DLT , respectively.
The number of attempts on intubation and repositionings of the DLT during surgery will be recorded.
The volume of air in the bronchial and tracheal cuff will be recorded. Information about the adequacy of lung separation will be obtained by the surgeons.
Postoperative clinical and X-ray follow up will be performed about lung recruitment and ventilatory complications ( atelectasis, pneumonia) Throughout the study no additional x-ray or laboratory checkup will be required, and no additional invasive procedures or treatment will be performed, than the usually accepted.
Statistical analysis of collected clinical and rentgenologic data will be performed .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- After obtaining informed consent, male and female patients over 18 years of age, candidates for elective thoracic surgery obliging DLT intubation, will be enrolled in the study. Children, pregnant and mentally incompetent patients will not be included.
Key inclusion criteria (1 listed)
- male and female patients over 18 years of age , candidates for elective thoracic surgery obliging DLT intubation, will be enrolled in the study
Key exclusion criteria (1 listed)
- Children, pregnant and mentally incompetent patients will not be included
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2008.
- Background: PubMed 10702432Campos JH, Massa FC, Kernstine KH. The incidence of right upper-lobe collapse when comparing a right-sided double-lumen tube versus a modified left double-lumen tube for left-sided thoracic surgery. Anesth Analg. 2000 Mar;90(3):535-40. doi: 10.1097/00000539-200003000-00007.
- Background: PubMed 9661566Chow MY, Liam BL, Lew TW, Chelliah RY, Ong BC. Predicting the size of a double-lumen endobronchial tube based on tracheal diameter. Anesth Analg. 1998 Jul;87(1):158-60. doi: 10.1097/00000539-199807000-00033.
- Background: PubMed 3674473Benumof JL, Partridge BL, Salvatierra C, Keating J. Margin of safety in positioning modern double-lumen endotracheal tubes. Anesthesiology. 1987 Nov;67(5):729-38. doi: 10.1097/00000542-198711000-00018.
- Background: PubMed 9477054Klein U, Karzai W, Bloos F, Wohlfarth M, Gottschall R, Fritz H, Gugel M, Seifert A. Role of fiberoptic bronchoscopy in conjunction with the use of double-lumen tubes for thoracic anesthesia: a prospective study. Anesthesiology. 1998 Feb;88(2):346-50. doi: 10.1097/00000542-199802000-00012.
- Background: PubMed 9972745Chow MY, Liam BL, Thng CH, Chong BK. Predicting the size of a double-lumen endobronchial tube using computed tomographic scan measurements of the left main bronchus diameter. Anesth Analg. 1999 Feb;88(2):302-5. doi: 10.1097/00000539-199902000-00014.
- Background: PubMed 18227288Amar D, Desiderio DP, Heerdt PM, Kolker AC, Zhang H, Thaler HT. Practice patterns in choice of left double-lumen tube size for thoracic surgery. Anesth Analg. 2008 Feb;106(2):379-83, table of contents. doi: 10.1213/ane.0b013e3181602e41.
- Background: PubMed 17400979Bussieres JS, Lacasse Y, Cote D, Beauvais M, St-Onge S, Lemieux J, Soucy J. Modified right-sided Broncho-Cath double lumen tube improves endobronchial positioning: a randomized study. Can J Anaesth. 2007 Apr;54(4):276-82. doi: 10.1007/BF03022772.
- Background: PubMed 10527220Eberle B, Weiler N, Vogel N, Kauczor HU, Heinrichs W. Computed tomography-based tracheobronchial image reconstruction allows selection of the individually appropriate double-lumen tube size. J Cardiothorac Vasc Anesth. 1999 Oct;13(5):532-7. doi: 10.1016/s1053-0770(99)90003-4.
- Background: PubMed 9105987Hannallah M, Benumof JL, Silverman PM, Kelly LC, Lea D. Evaluation of an approach to choosing a left double-lumen tube size based on chest computed tomographic scan measurement of left mainstem bronchial diameter. J Cardiothorac Vasc Anesth. 1997 Apr;11(2):168-71. doi: 10.1016/s1053-0770(97)90208-1.
- Background: PubMed 18635507Neustein SM. What is the best choice for size of double lumen tube? Anesth Analg. 2008 Jul;107(1):342-3. doi: 10.1213/ane.0b013e318173e773. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Surgery, run by Assaf-Harofeh Medical Center.
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 1 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: status not confirmed, as of the sponsor's last update on 19 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00793936, which also lists 10 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 19 Nov 2008.