Effect of Laryngeal Mask Cuff Pressure in Geriatric Patients

NCT02189954 | Completed Phase 4 Results

• 1 other identifier: 269-GOA
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anaesthesia

Keywords

elderly; laryngeal masks; postoperative complications

Outcome Measures

Primary Outcomes (1)

• Postoperative Pharyngolaryngeal Morbidity 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 1.hour

Secondary Outcomes (1)

• Postoperative Pharyngolaryngeal Morbidity at Postoperative 24.Hour

  Postoperative 24.hour

Study Arms (2)

Group Routine Care

ACTIVE COMPARATOR

The placement according to the manufacturer's instructions.

Procedure: The placement according to the manufacturer's instructions

Group Pressure Limiting

EXPERIMENTAL

Cuff inner pressure was held below 44 mmHg

Procedure: Cuff inner pressure was held below 44 mmHg

Interventions

The placement according to the manufacturer's instructions PROCEDURE

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

Group Routine Care

Cuff inner pressure was held below 44 mmHg PROCEDURE

cuff pressure limitation (Group Pressure Limiting (PL), n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)

Group Pressure Limiting

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Above the age of 65
• ASA I-III
• Undergoing elective surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation

Izmi̇r, 35320, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitations of our study include the lack of imaging with a fiberoptic bronchoscope after LMU placement and not evaluating the position in the hypopharynx of the supraglottic airway device in the geriatric age group.

Results Point of Contact

• Title: Anaesthesiology and Reanimation, Dr. Sule Ozbilgin
• Organization: DorkuzEU

ozbilginsule@gmail.com

0905055252901

Study Officials

• FERİM GÜNENÇ, M.D.

  Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anaesthesiology and Reanimation

Study Record Dates

• First Submitted: June 28, 2014
• First Posted: July 15, 2014
• Study Start: July 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 31, 2015
• Results First Posted: August 31, 2015

Record last verified: 2015-08

Locations

TU (1)