Criteria for Choice of Right Double Lumen Tube (DLT)

Thoracic Surgery Clinical Trial

Official title:

Criteria for Choice of Right Double Lumen Tube for Lung Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00793936
• Other study ID #: 160.08
• Status: Not yet recruiting
• Phase: N/A
• First received: November 18, 2008
• Last updated: November 18, 2008
• Start date: November 2008
• Est. completion date: December 2009

Study information

• Verified date: November 2008
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical 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?

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• male and female patients over 18 years of age , candidates for elective thoracic surgery obliging DLT intubation, will be enrolled in the study

Exclusion Criteria:

• Children, pregnant and mentally incompetent patients will not be included

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thoracic Surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

References & Publications (10)

Amar 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. — View Citation

Benumof JL, Partridge BL, Salvatierra C, Keating J. Margin of safety in positioning modern double-lumen endotracheal tubes. Anesthesiology. 1987 Nov;67(5):729-38. — View Citation

Bussières JS, Lacasse Y, Côté 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. — View Citation

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. — View Citation

Chow 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. — View Citation

Chow 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. — View Citation

Eberle 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. — View Citation

Hannallah 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. — View Citation

Klein 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. — View Citation

Neustein 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. — View Citation