Intubation, Intratracheal Clinical Trial
Official title:
Comparison of Individually Modified Angled Tube and Conventional Angled Tube in Double-lumen Endotracheal Tube Intubation: A Randomized Clinical Trial
Verified date | February 2015 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Institutional Review Board |
Study type | Interventional |
The investigators are trying to compare the individually modified-angled tube and the conventional-angled tube in ease of double lumen endotracheal tube insertion and the incidence of related postoperative complications.
Status | Completed |
Enrollment | 108 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Subjects undergoing thoracic surgery under one lung ventilation - Subjects older than 20 yrs who can give written informed consent Exclusion Criteria: - Those who need rapid sequence intubation - Those with cervical spinal disease (cervical spinal injury, rheumatoid arthritis with atlantoaxial subluxation) - Those with oropharyngeal obstructive disease (including tumor, foreign body) - Those who are expected prolonged intubation after surgery - Those who are pregnant |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hemodynamic change | We will record patient's heart rate, blood pressure and any used cardiovascular drugs at 1, 3 and 5 min after intubation | 1, 3 and 5 min after intubation | No |
Other | Intubation difficulty scale score | Intubation difficulty Scale score is a function of seven parameters : number of attempts, number of operators, number of alternative techniques, cormack grade, lifting force needed, laryngeal pressure and vocal cord mobility. (Ref: Intubation Difficulty Scale, Anesthesiology 1997;87:1290-7) |
At intubation | No |
Primary | The time taken to intubate a double-lumen tube | The time taken to insert the tube begins when the laryngoscope passes the patient's lips and ends when the tube passes the vocal cords | within 60 sec | No |
Secondary | The number of attempts needed for successful intubation | Intubation | No | |
Secondary | The time taken for the first attempt of intubation | within 60 sec | No | |
Secondary | Postoperative sore throat, hoarseness or dysphagia | 30 minutes and 24hours after extubation | No |
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