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N/A N=141 Randomized Double-blind Prevention

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

Post Operative Sore Throat · Dysphagia · Hoarseness

Enrolled (actual)
141
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Incidence of Tracheopharyngeal Symptoms — 53; 49 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
cuff manometer (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of California, San Francisco
Primary completion
Dec 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Incidence of Tracheopharyngeal Symptoms
53; 49

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.

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01305265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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