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

NCT01305265 | Completed Results

• 1 other identifier: weottp
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Sore Throat; Dysphagia; Hoarseness

Keywords

sore throat; dysphagia; hoarseness; post operative; endotracheal intubation

Outcome Measures

Primary Outcomes (1)

• Incidence of Tracheopharyngeal Symptoms

  within 2 hours after extubation

Study Arms (2)

intervention

ACTIVE COMPARATOR

Endotracheal tube will be adjusted to 22-26 cm H20 pressure immediately post intubation using a cuff manometer

Device: cuff manometer

control

NO INTERVENTION

endotracheal tube cuff will be inflated using standard technique

Interventions

cuff manometer DEVICE

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

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Deglutition Disorders; Hoarseness; Pharyngitis

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Respiratory Tract Infections; Infections; Stomatognathic Diseases

Results Point of Contact

• Title: Kolodzie, Kerstin M.D, PhD, Principal Investigator
• Organization: Dept. of Anesthesia & Perioperative Care, UCSF San Francisco

kolodziek@anesthesia.ucsf.edu

4158853647

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: February 28, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 26, 2014
• Results First Posted: February 26, 2014

Record last verified: 2014-01

Locations

US (1)