Comparison of Different Bending Mode for Double-lumen Endotracheal Tube Intubation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01605591
First received: October 16, 2011
Last updated: May 21, 2012
Last verified: August 2011
  Purpose

The purpose of this study is to comparing the effects of different double-lumen endotracheal tube's bending type in tracheal intubation.


Condition Intervention
Anesthesia Intubation Complications
Procedure: the DLT bending to the right
Procedure: the DLT bending to the left

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Different Bending Mode for Double-lumen Endotracheal Tube Intubation

Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • Main outcome measure is the successful rate of the first intubation compared with the two bending modes of DLT [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the time needed to insert the DLT during the period of intubation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • mean blood pressure (MAP) before intubation, and after intubation 1, 3,and 5 min [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • the incidence of hypoxemia during the period of intubation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Hypoxemia is defined as the SPO2 is below 90%.

  • the heart rate (HR) before intubation, and after intubation 1, 3,and 5 min [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • the incidence of sore throat after extubation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • the incidence of hoarseness after extubation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: August 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: the DLT bending to the right Procedure: the DLT bending to the right
bending the bronchial lumen of DLT 60~90 degrees in the same side with the tracheal lumen
Other Name: different bending mode of DLT
Active Comparator: the DLT bending to the left Procedure: the DLT bending to the left
bending the bronchial lumen of DLT 60~90 degree opposed to the tracheal lumen
Other Name: different bending mode of DLT

Detailed Description:

Intubation with the double-lumen endotracheal tube (DLT) remains a great challenge for anesthesiologists. Although new upper airway devices, such as GlideScope(R) videolaryngoscope, had been developed for facilitating airway management, the larger size and the complexity of DLT than single-lumen tube (SLT) makes the difficulties for DLT intubation. Therefore, the investigators designed this study to investigate the effects of different bending type of DLT in tracheal intubation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. American Society of Anesthesiologists physical status I-III
  2. more than 18 years of age
  3. Receiving thoracic surgery with double-lumen endobronchial tube

Exclusion Criteria:

  1. risk of regurgitation and pulmonary aspiration
  2. history of gastroesophageal reflux
  3. pregnancy
  4. scheduled tracheostomy and postoperative prolonged ventilation in ICU
  5. limited neck extension (< 35°)
  6. a thyromental distance less than 7 cm
  7. a sternomental distance less than 12.5 cm with the head fully extended
  8. mouth can not open
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605591

Contacts
Contact: Hung-Te Hsu, VS +886-7-312-1101 ext 7033 hdhsu1228@hotmail.com

Locations
Taiwan
department of anesthesia, Kaohsiung medical university memorial hospital Recruiting
Kaohsiung, Taiwan, 807
Contact: Hung-Te Hsu, VS    +886-7-312-1101 ext 7033    hdhsu1228@hotmail.com   
Principal Investigator: Hung-Te Hsu, VS         
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
Principal Investigator: Hung-Te Hsu, VS Department of anesthesia, Kaoshiung medical university hospital
  More Information

No publications provided

Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01605591     History of Changes
Other Study ID Numbers: KMUH-IRB-20110172
Study First Received: October 16, 2011
Last Updated: May 21, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
left-side double lumen bronchial tube
bending type
GlideScope videolaryngoscope

ClinicalTrials.gov processed this record on July 29, 2014