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

NCT ID: NCT01305265

Last Updated: 2014-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

intervention

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

Group Type: ACTIVE_COMPARATOR

cuff manometer

Intervention Type: DEVICE

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

control

endotracheal tube cuff will be inflated using standard technique

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

cuff manometer

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

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of California San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

weottp

Identifier Type: -

Identifier Source: org_study_id