Effect of Laryngeal Mask Cuff Pressure in Geriatric Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02189954 |
Recruitment Status :
Completed
First Posted : July 15, 2014
Results First Posted : August 31, 2015
Last Update Posted : August 31, 2015
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anaesthesia | Procedure: The placement according to the manufacturer's instructions Procedure: Cuff inner pressure was held below 44 mmHg | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Screening |
Official Title: | Effect of Laryngeal Mask Cuff Pressure on Postoperative Pharyngolaryngeal Complications in Geriatric Patients |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | August 2012 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Group Routine Care
The placement according to the manufacturer's instructions.
|
Procedure: The placement according to the manufacturer's instructions
Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®(LMU)) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience |
Experimental: Group Pressure Limiting
Cuff inner pressure was held below 44 mmHg
|
Procedure: Cuff inner pressure was held below 44 mmHg
cuff pressure limitation (Group Pressure Limiting (PL), n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg) |
- Postoperative Pharyngolaryngeal Morbidity Postoperative 1.Hour [ Time Frame: Postoperative 1.hour ]The primary outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert scale ranges from 1 (none) to 4 (severe) at postoperative 1.hour
- Postoperative Pharyngolaryngeal Morbidity at Postoperative 24.Hour [ Time Frame: Postoperative 24.hour ]The primer outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert scale ranges from 1 (none) to 4 (severe) at postoperative 24.hour

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189954
Turkey | |
Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation | |
Izmi̇r, Turkey, 35320 |
Principal Investigator: | FERİM GÜNENÇ, M.D. | Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation |
Responsible Party: | Sule Ozbilgin, Anaesthesiology and Reanimation, Dokuz Eylul University |
ClinicalTrials.gov Identifier: | NCT02189954 |
Other Study ID Numbers: |
269-GOA |
First Posted: | July 15, 2014 Key Record Dates |
Results First Posted: | August 31, 2015 |
Last Update Posted: | August 31, 2015 |
Last Verified: | August 2015 |
elderly; laryngeal masks; postoperative complications |