Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Sule Ozbilgin, Dokuz Eylul University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Screening
Condition Anaesthesia
Interventions Procedure: The placement according to the manufacturer's instructions
Procedure: Cuff inner pressure was held below 44 mmHg
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group Routine Care Group Pressure Limiting
Hide Arm/Group Description

The placement according to the manufacturer's instructions.

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 bispectral index (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

Cuff inner pressure was held below 44 mmHg

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

Period Title: Overall Study
Started 45 45
Completed 45 45
Not Completed 0 0
Arm/Group Title Group Routine Care Group Pressure Limiting Total
Hide Arm/Group Description

The placement according to the manufacturer's instructions.

The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) 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

Cuff inner pressure was held below 44 mmHg

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

Total of all reporting groups
Overall Number of Baseline Participants 45 45 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 45 participants 90 participants
71.9  (5.4) 72.8  (6.2) 72.4  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
Female
22
  48.9%
23
  51.1%
45
  50.0%
Male
23
  51.1%
22
  48.9%
45
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Turkey Number Analyzed 45 participants 45 participants 90 participants
45 45 90
1.Primary Outcome
Title Postoperative Pharyngolaryngeal Morbidity Postoperative 1.Hour
Hide Description 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
Time Frame Postoperative 1.hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group Routine Care Group Pressure Limiting
Hide Arm/Group Description:

The placement according to the manufacturer's instructions.

The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) 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

Cuff inner pressure was held below 44 mmHg

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

Overall Number of Participants Analyzed 45 45
Median (Full Range)
Unit of Measure: units on a scale
1
(1 to 4)
1
(1 to 2)
2.Secondary Outcome
Title Postoperative Pharyngolaryngeal Morbidity at Postoperative 24.Hour
Hide Description 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
Time Frame Postoperative 24.hour
Hide Outcome Measure Data
Hide Analysis Population Description
Chi Square Test for categorical variables, for constant variables t test when suitable for normal distribution and when unsuitable for normal distrubition Mann Whitney U have been used for analysis. p < 0.05 was considered significant.
Arm/Group Title Group Routine Care Group Pressure Limiting
Hide Arm/Group Description:

The placement according to the manufacturer's instructions.

The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) 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

Cuff inner pressure was held below 44 mmHg

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

Overall Number of Participants Analyzed 45 45
Median (Full Range)
Unit of Measure: units on a scale
1
(1 to 3)
1
(1 to 1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group Routine Care, Group Pressure Limiting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group Routine Care, Group Pressure Limiting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mann Whitney U
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group Routine Care Group Pressure Limiting
Hide Arm/Group Description

The placement according to the manufacturer's instructions.

The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) 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

Cuff inner pressure was held below 44 mmHg

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

All-Cause Mortality
Group Routine Care Group Pressure Limiting
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Group Routine Care Group Pressure Limiting
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/45 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group Routine Care Group Pressure Limiting
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/45 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anaesthesiology and Reanimation, Dr. Sule Ozbilgin
Organization: DorkuzEU
Phone: 0905055252901
EMail: ozbilginsule@gmail.com
Layout table for additonal information
Responsible Party: Sule Ozbilgin, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT02189954    
Other Study ID Numbers: 269-GOA
First Submitted: June 28, 2014
First Posted: July 15, 2014
Results First Submitted: April 26, 2015
Results First Posted: August 31, 2015
Last Update Posted: August 31, 2015