Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03524586
Other study ID # 2017-12-001-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2, 2018
Est. completion date May 1, 2018

Study information

Verified date May 2018
Source Kyungpook National University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the endotracheal tube cuff pressure of a taper-guard cuffed tube during tympanoplasty with ipsilateral rotation of head, compared to the contralateral rotation of head.

The investigators will performed the ipsilateral rotation of head against the fixed tube in half of participants or the contralateral rotation of head in the other half.


Description:

The inflation of the endotracheal tube cuff is very useful to prevent aspiration of contaminated substances into lung past endotracheal tube and leakage of gas during positive pressure ventilation. However, excessive inflation of endotracheal tube cuff frequently causes tracheal mucosal damage, which can increase the incidence of sore throat, hoarseness, and coughing after surgery.

Taper-guard cuffed tube was newly developed. Taper-guard endotracheal tube is more effective in providing a sealing effect than a cylindrical endotracheal tube in an in vitro study. However, recently, it was reported that the cuff pressure of a Taper-guard endotracheal tube significantly increased after a positional change from the supine to the lateral flank position, compared to that of a cylindrical endotracheal tube. However, during tympanoplasty, the investigators need to rotate head for proper position.

In this study, therefore, the investigators investigate the difference of the endotracheal tube cuff pressure of a taper-guard cuffed tube between ipsilateral and contralateral rotation of head against the fixed tube during tympanoplasty.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date May 1, 2018
Est. primary completion date April 5, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- American Society of Anesthesiologists physical status classification I-III for a tympanoplasty under general anesthesia

Exclusion Criteria:

- history of difficult intubation, limited neck movement, respiratory diseases, and body mass index >35kg/m2

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ipsilateral rotation of head
Ipsilateral rotation of head against fixed tube
Contralateral rotation of head
Contralateral rotation of head against fixed tube

Locations

Country Name City State
Korea, Republic of Kyungpook national university hospital Daegu

Sponsors (1)

Lead Sponsor Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary The endotracheal tube cuff pressure The endotracheal tube cuff pressure was checked using a manometer During procedure
Secondary The distance from the endotracheal tube tip to the carina The distance from the endotracheal tube tip to the carina was recorded again using a fiberoptic bronchoscope. During procedure
See also
  Status Clinical Trial Phase
Completed NCT03908411 - The Effect of Paratracheal Pressure on the Glottic View N/A
Completed NCT04564105 - Simulation Training and Teamwork Concerning Intubation on the Icu N/A
Completed NCT02988336 - TMHT - New Method of Difficult Intubation Prediction N/A
Completed NCT03002857 - Comparison of I-gel LMA, Classical LMA With a New Supraglottic Airway the Baska Mask® in Urological Surgery N/A
Recruiting NCT06337006 - Laryngeal Mask Airway Failure in Pediatric Patients
Completed NCT03443219 - RCT- LMA Supremeā„¢ Versus the Spritztube® Tracheal Cannula in Anesthetized Adult Patients N/A
Completed NCT05044416 - VieScope in Patients With an Expected Difficult Airway N/A
Not yet recruiting NCT05534451 - Comparison Among Three Different Video Scope Guided Nasotracheal Intubation. N/A
Recruiting NCT06073977 - Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation
Not yet recruiting NCT03687385 - The Effect of High-flow Nasal Oxygenation to the Saturation During Analgo-sedation in Different ASA Risk Class Patients N/A
Not yet recruiting NCT03687424 - Can High-flow Nasal Oxygenation Improve Oxygen Saturation During Analgo-sedation in Obese Adults? N/A
Enrolling by invitation NCT05055401 - Airway Management Skills Amongst Anesthesia Providers
Not yet recruiting NCT02920879 - Airway Effects of PEEP During Anesthesia Induction. N/A
Terminated NCT02644837 - AuraGain and iGel Crossover Comparison N/A
Completed NCT02263300 - Spatial Orientation and Fiberoptic Intubation Skills in the Novice: A Randomized Controlled Trial
Completed NCT01718561 - The Difficult Airway Management Trial: "The DIFFICAIR-Trial" N/A
Completed NCT01635660 - Out-of-Hospital Randomized Comparison of Video-assisted Endotracheal Intubation N/A
Completed NCT00956592 - Clinical Evaluation of the Storz CMAC Laryngoscope N/A
Completed NCT00892671 - Airway Management and Vascular Access Simulation N/A
Completed NCT03848559 - Airway Management With Simulated Microgravity Using a Submerged Model N/A