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Heated Breathing Circuit on Postoperative Sore Throat After Double-lumen Endobronchial Tube Insertion

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ClinicalTrials.gov Identifier: NCT03689127
Recruitment Status : Not yet recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Hyun-Chang Kim, Keimyung University Dongsan Medical Center

Brief Summary:
This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of heated breathing circuit in patients undergoing double-lumen endotracheal intubation.

Condition or disease Intervention/treatment Phase
Lung Surgery Device: Heated breathing circuit on Device: Heated breathing circuit off Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Influence of Heated Breathing Circuit on Postoperative Sore Throat in Patients Undergoing Double-lumen Endobronchial Tube Insertion
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arm Intervention/treatment
Active Comparator: Control
Heated breathing circuit will be turned off.
Device: Heated breathing circuit off
Heated breathing circuit will be turned off.

Experimental: Heat
Heated breathing circuit will be turned on.
Device: Heated breathing circuit on
Heated breathing circuit will be turned on.




Primary Outcome Measures :
  1. Number of participants with postoperative sore throat for postoperative 24 h [ Time Frame: At 24 hours ]

Secondary Outcome Measures :
  1. Number of participants with postoperative sore throat [ Time Frame: At 1, 6, and 24 hours ]
  2. Postoperative sore throat scores [ Time Frame: At 1, 6, and 24 hours ]
  3. Number of participants with postoperative hoarseness [ Time Frame: At 1, 6, and 24 hours ]
  4. Number of participants with postoperative shivering [ Time Frame: At 1, 6, and 24 hours ]
  5. Wound pain scores [ Time Frame: At 1, 6, and 24 hours ]
    Visual anlogue scales will be used (10: most imaginable pain, 0: no pain).

  6. Jaw discomfort scores [ Time Frame: At 1, 6, and 24 hours ]
    Visual anlogue scales will be used (10: most imaginable pain, 0: no pain).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-III
  • Patients scheduled for double-lumen endotracheal intubation

Exclusion Criteria:

  • Difficult airway
  • Mallampatti scores greater than 2
  • Recent sore throat
  • Cervical spine disease
  • Recent upper respiratory infection
  • Recent analgesics
  • History of head and neck surgery
  • Friable teeth
  • Multiple intubation attempts

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689127


Contacts
Contact: Hyun Chang Kim +821028862876 onidori1979@gmail.com

Locations
Korea, Republic of
Hyun-Chang Kim
Daegu, Non-US/Canada, Korea, Republic of, 137-040
Sponsors and Collaborators
Keimyung University Dongsan Medical Center

Responsible Party: Hyun-Chang Kim, Assistant professor, Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier: NCT03689127     History of Changes
Other Study ID Numbers: Heated Circuit POST
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hyun-Chang Kim, Keimyung University Dongsan Medical Center:
intubation
pharyngitis

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases