Post-operative Sore Throat as Determined by Endotracheal Tube Inflation Technique

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01305265
First received: February 24, 2011
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to test whether the incidence of sore throat and other tracheal co-morbidities such as dysphagia and hoarseness can be lessened by use of a cuff manometer at the beginning of surgery to inflate to the proper pressure compared to the standard technique.

The investigators hypothesis is that inflation of the endotracheal balloon using a cuff manometer immediately after intubation will reduce the incidence of sore throat and other tracheal co-morbidities.


Condition Intervention
Post Operative Sore Throat
Dysphagia
Hoarseness
Device: cuff manometer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Post-operative Sore Throat as Determines by Endotracheal Tube Inflation Technique

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Incidence of Tracheopharyngeal Symptoms [ Time Frame: within 2 hours after extubation ] [ Designated as safety issue: No ]

Enrollment: 141
Study Start Date: November 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: intervention
Endotracheal tube will be adjusted to 22-26 cm H20 pressure immediately post intubation using a cuff manometer
Device: cuff manometer
endotracheal tube cuff will be inflated to 22-26 cm H20 using cuff manometer
No Intervention: control
endotracheal tube cuff will be inflated using standard technique

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Scheduled for general anesthesia requiring endotracheal intubation with planned duration of at least 2 hours
  • ASA I-3

Exclusion Criteria:

  • Planned prolonged intubation
  • Planned postoperative ICU admission
  • Non English speaking
  • Mentally impaired
  • Existing tracheal stoma
  • Nasogastric tube in place preoperative
  • Thyroid / intra-oral surgery
  • Previous general anesthesia within the last 2 weeks
  • Use of steroids within one week before surgery (IV,inhaled, oral)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305265

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01305265     History of Changes
Other Study ID Numbers: weottp
Study First Received: February 24, 2011
Results First Received: January 6, 2014
Last Updated: January 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
sore throat
dysphagia
hoarseness
post operative
endotracheal intubation

Additional relevant MeSH terms:
Deglutition Disorders
Hoarseness
Pharyngitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Respiration Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Stomatognathic Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 22, 2014