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

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305265
• Other study ID #: weottp
• Status: Completed
• Phase: N/A
• First received: February 24, 2011
• Last updated: January 6, 2014
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dysphagia
• Dysphonia
• Hoarseness
• Pharyngitis
• Post Operative Sore Throat

Intervention

Device:
• cuff manometer
endotracheal tube cuff will be inflated to 22-26 cm H20 using cuff manometer

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Tracheopharyngeal Symptoms		within 2 hours after extubation	No