N/A
Completed N=100
No Post Intubation Laryngeal Symptoms
Sore throat · Dysphonia · Dysphagia · Intubation Complication
Source: ClinicalTrials.gov NCT05383417 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: Sore Throat on a Scale From 0 (no Sore Throat) to 10 (Worst Possible Sore Throat) — 1.85; 1.9; 1.1; 1.62 score on a scale — p=0.03
Summary
The purpose of the study is to test a novel endotracheal tube support device that reduces pressure of the tube on the voice box for prevention of post intubation laryngeal symptoms including sore throat, change in voice and trouble swallowing.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sore Throat on a Scale From 0 (no Sore Throat) to 10 (Worst Possible Sore Throat) |
1.85; 1.9; 1.1; 1.62; 0.53; 1.12 | 0.03 sig |
| PRIMARY Change in Voice on a Scale From 0 (no Voice Change) to 10 (Most Severe Voice Change) |
1.87; 2.21; 1.13; 1.30; 0.59; 0.83 | 0.18 |
| PRIMARY Difficulty Swallowing on a Scale From 0 (no Difficulty Swallowing) to 10 (Complete Inability to Swallow) |
1.04; 1.21; 0.58; 1.13; 0.20; 0.94 | 0.007 sig |
| PRIMARY Pain in the Mouth on a Scale From 0 (no Mouth Pain) to 10 (Worst Possible Mouth Pain) |
0.07; 0.42; 0.06; 0.28; 0.04; 0.27 | 0.03 sig |
| PRIMARY Difficulty Talking on a Scale From 0 (no Difficulty Talking) to 10 (Complete Inability to Talk) |
0.87; 1.09; 0.35; 0.96; 0.29; 0.61 | 0.04 sig |
| PRIMARY Pain in the Neck/Chest on a Scale From 0 (no Neck/Chest Pain) to 10 (Worst Possible Neck/Chest Pain) |
0.37; 0.77; 0.25; 0.68; 0.16; 0.71 | 0.02 sig |
| PRIMARY Patients With Post Operative Mouth Pain |
6; 24 | <0.001 sig |
| PRIMARY Patients With Post Operative Sore Throat |
65; 82 | 0.007 sig |
| PRIMARY Patients With Post Operative Neck/Chest Pain |
16; 35 | <0.001 sig |
| PRIMARY Patients With Post Operative Voice Change |
66; 67 | 0.39 |
| PRIMARY Patients With Post Operative Difficulty Talking |
24; 49 | <0.001 sig |
| PRIMARY Patients With Post Operative Difficulty Swallowing |
31; 60 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patient undergoing general endotracheal anesthesia with an endotracheal tube
- Patient is not undergoing a procedure in the head and neck region
Exclusion Criteria
- Patient with pre-existing severe sore throat, voice change, or trouble swallowing
- Patient undergoing surgery in the head and neck region
Data sourced from ClinicalTrials.gov (NCT05383417). 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. Informational only — not medical advice.