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Trial record 3 of 149 for:    shape, cervical

Tracheal Tube Cuff Shape and Pressure

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ClinicalTrials.gov Identifier: NCT04591769
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan

Brief Summary:
This is a randomized controlled trial focusing on the effect of different tracheal tube cuff shape; the tapered-shaped tracheal tube cuff versus the cylindrical-shaped tracheal cuff in anterior cervical spine surgery.

Condition or disease Intervention/treatment Phase
Intubation, Intratracheal Pain, Postoperative Dysphonia Device: Different tracheal tube cuff design Not Applicable

Detailed Description:
High endotracheal cuff pressure (ETCP) during surgical retractor splay associates with recurrent laryngeal nerve paresis/ palsy and results in post-anterior cervical spine surgery (post-ACSS) dysphonia. Control of intraoperative ETCP during ACSS may benefit voice outcome. The taper-shaped tracheal tube cuff was originally designed as a new strategy to reduce fluid leakage across the conventional cylindrical cuff and prevention of ventilator associated pneumonia. Literature has revealed the just seal pressure for the tapered-shaped tracheal tube (TT) cuff was lower than conventional cylindrical cuff. Therefore the investigators hypothesize that use of a tapered-shaped ET cuff during the surgery can lead to a lower ETCP during retractors splay and improve voice recovery after ACSS. In this study, 80 patients were randomized into 2 groups, to receive endotracheal intubation using TaperGuard tracheal tube (tapered- shaped cuff) or a conventional tracheal tube (a cylindrical cuff). The just seal pressure, intraoperative cuff pressure, and postoperative sore throat and voice outcome are recorded and compared.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The patient will be intubated by an anesthesiologist who is aware of the grouping. After tracheal intubation is finished, the cuff is connected to the pressure monitor system and another blinded assessor will adjust and record the minimal volume that is required for sealing the tracheal tube-ventilator. The cuff pressure will be monitored and recorded all throughout the surgical period. A blinded assessor will follow up the patient after the surgery and do the voice analysis. Patients are unaware of the type of tracheal tube they used and will score subjectively for the sore throat and postoperative dysphonia.
Primary Purpose: Prevention
Official Title: Cuff Pressure During Surgical Retractor Splay and Postoperative Voice Outcome After Anterior Cervical Spine Surgery: Comparison Between Tapered-shaped and Conventional Cylindrical-shaped Endotracheal Tube
Actual Study Start Date : November 5, 2020
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : November 30, 2022

Arm Intervention/treatment
Experimental: Group T(Tapered- shaped)
Tracheal intubation using TaperedGuard Tracheal Tube
Device: Different tracheal tube cuff design
Comparison of effect between 2 different designs of tracheal tube cuff

Active Comparator: Group C(Cylindrical-shaped)
Tracheal intubation using Hi-Contour Tracheal Tube
Device: Different tracheal tube cuff design
Comparison of effect between 2 different designs of tracheal tube cuff




Primary Outcome Measures :
  1. Just seal tracheal tube cuff pressure [ Time Frame: 1 minute after anesthesia and tracheal intubation ]
    Minimal tracheal tube cuff pressure that prevent leakage of the ventilator system

  2. Tracheal tube cuff pressure on retractor splay [ Time Frame: Intraoperative monitoring ]
    Cuff pressure when the retractors are set-up and removed


Secondary Outcome Measures :
  1. Sore throat-NRS [ Time Frame: preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7 ]
    Postoperative sore throat, Numeric Rating Scale(NRS) 0~10; 0=no sore throat; 10=maximal sore throat

  2. Sore throat-VAS [ Time Frame: preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7 ]
    Postoperative sore throat, Visual Analogue Scale (VAS) 0~10; 0=no sore throat; 10=maximal sore throat

  3. Subjective dysphonia [ Time Frame: preOP day 1, post OP 2 hours, day 1, 2, 3, 7 ]
    Hoarseness; Pitch; Loudness (0= none; 1= mild; 2= severe); compared with baseline

  4. Subjective dysphonia-GRBAS score [ Time Frame: One day before operation, and post operation day 1 ]
    GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) score (normal, slight, moderate, severe); compared with baseline

  5. Subjective dysphonia- Voice Handicap Index-10(VHI-10) [ Time Frame: One day before operation, and post operation day 7 ]
    VHI-10 questionnaire (0 best~40 worst; >15 may be abnormal)

  6. Objective dysphonia [ Time Frame: One day before operation(baseline), and post operation day 1 ]
    Software voice analysis; compared with baseline

  7. Postoperative complication [ Time Frame: After operation to post operation day 7 ]
    Any postoperative complication related complication



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Receiving elective anterior cervical spine surgery
  • Right side approach

Exclusion Criteria:

  • Unstable cervical spine (acute trauma history, or dislocation/ subluxation in image studies)
  • Anticipated difficult airway
  • Facial anomaly that may hinder facemask ventilation
  • Preoperative hoarseness or vocal cord palsy regardless of etiology
  • Re-operation of cervical spine surgery or left side approach
  • BMI >35
  • Operation field involved cervical spine C1 or C2
  • Unwilling to sign the informed consent
  • Unwilling to finish the study

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): NCT04591769


Contacts
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Contact: Ya-Chun Chu, MD, PhD 886-2-28757549 yachunchu@gmail.com

Locations
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Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Ya-Chun Chu       yachunchu@gmail.com   
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Study Chair: Ya-Chun Chu, MD, PhD Taipei Veterans General Hospital, Taiwan
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Responsible Party: vghtpe user, Ya-Chun Chu, MD, PhD, Chief of Division of Neuroanesthesia, Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT04591769    
Other Study ID Numbers: 2020-10-002C
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Beginning 9 months and ending 36 months following article publication.
Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee. Proposals should be directed to yachunchu@gmail.com. To gain access, data requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dysphonia
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Nervous System Diseases