Criteria for Choice of Right Double Lumen Tube (DLT)

Sponsor
Assaf-Harofeh Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00793936
Collaborator
(none)
40
13

Study Details

Study Description

Brief 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?

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Criteria for Choice of Right Double Lumen Tube for Lung Surgery
    Study Start Date :
    Nov 1, 2008
    Anticipated Primary Completion Date :
    Aug 1, 2009
    Anticipated Study Completion Date :
    Dec 1, 2009

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Assaf-Harofeh Medical Center

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00793936
      Other Study ID Numbers:
      • 160.08
      First Posted:
      Nov 19, 2008
      Last Update Posted:
      Nov 19, 2008
      Last Verified:
      Nov 1, 2008
      Keywords provided by , ,

      Study Results

      No Results Posted as of Nov 19, 2008