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NCT Number: NCT04591769

Tracheal Tube Cuff Shape and Pressure

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.

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Key information

Conditions

Intubation, Intratracheal Dysphonia Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiratory Tract Diseases Signs and Symptoms Voice Disorders

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Different tracheal tube cuff design

Device

Comparison of effect between 2 different designs of tracheal tube cuff

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2020
Registry last updated
Sep 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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