ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01305265
Recruitment Status : Completed
First Posted : February 28, 2011
Results First Posted : February 26, 2014
Last Update Posted : February 26, 2014
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

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 or disease Intervention/treatment Phase
Post Operative Sore Throat Dysphagia Hoarseness Device: cuff manometer Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Post-operative Sore Throat as Determines by Endotracheal Tube Inflation Technique
Study Start Date : November 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Incidence of Tracheopharyngeal Symptoms [ Time Frame: within 2 hours after extubation ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

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): NCT01305265


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

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01305265     History of Changes
Other Study ID Numbers: weottp
First Posted: February 28, 2011    Key Record Dates
Results First Posted: February 26, 2014
Last Update Posted: February 26, 2014
Last Verified: January 2014

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

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