Phase 4
N=90
Effect of Laryngeal Mask Cuff Pressure in Geriatric Patients
Anaesthesia
Bottom Line
View on ClinicalTrials.gov: NCT02189954 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Postoperative Pharyngolaryngeal Morbidity Postoperative 1.Hour — 1; 1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- The placement according to the manufacturer's instructions (Procedure); Cuff inner pressure was held below 44 mmHg (Procedure)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Dokuz Eylul University
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Pharyngolaryngeal Morbidity Postoperative 1.Hour |
1; 1 | — |
| SECONDARY Postoperative Pharyngolaryngeal Morbidity at Postoperative 24.Hour |
1; 1 | <0.05 sig |
Summary
Laryngeal Mask is widely used for air-way management during anaesthesia. Pharyngolaryngeal morbidity linked to laryngeal mask use is related to correct choice of mask size, placement technique, placement of the laryngeal mask in the correct position on the larynx, cuff volume and cuff pressure. It has been stated that keeping laryngeal mask cuff pressure below 45 mmHg (60 centimeter of water(cmH2O) ) can prevent pharyngolaryngeal morbidity related to laryngeal mask (throat pain, dysphonia, dysphagia) and shown that using a manometer after Laryngeal Mask Unique placement to limit pressure within the cuff can reduce this morbidity by nearly 70%. Studies commenting on pharyngolaryngeal morbidity generally do not choose a certain age group and cover stages including very young and middle-aged groups. In the literature only one similar study on the geriatric age group was found.
The aim of this study is to compare the postoperative pharyngolaryngeal morbidity in a group with cuff pressure held to 44 mmHg (60 cmH2O with a manometer and a group with Laryngeal Mask cuff inflated without reference to pressure in the geriatric age group with indications for Laryngeal Mask Unique placement.
Eligibility Criteria
Inclusion Criteria
- Above the age of 65
- ASA I-III
- Undergoing elective surgery
Exclusion Criteria
- Patients with recent history of upper respiratory infection
- Obese patients with body-mass index above 35 kg/m2
- Symptomatic hiatus hernia
- Severe gastroesophageal reflux
- Dementia
Data sourced from ClinicalTrials.gov (NCT02189954). 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.