Trial Outcomes & Findings for Effect of Laryngeal Mask Cuff Pressure in Geriatric Patients (NCT NCT02189954)
NCT ID: NCT02189954
Last Updated: 2015-08-31
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
90 participants
Primary outcome timeframe
Postoperative 1.hour
Results posted on
2015-08-31
Participant Flow
Participant milestones
| Measure |
Group Routine Care
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
|
Group Pressure Limiting
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)
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
45
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Laryngeal Mask Cuff Pressure in Geriatric Patients
Baseline characteristics by cohort
| Measure |
Group Routine Care
n=45 Participants
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
|
Group Pressure Limiting
n=45 Participants
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
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.9 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
72.8 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
72.4 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
45 participants
n=5 Participants
|
45 participants
n=7 Participants
|
90 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Postoperative 1.hourThe 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
Outcome measures
| Measure |
Group Routine Care
n=45 Participants
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
|
Group Pressure Limiting
n=45 Participants
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)
|
|---|---|---|
|
Postoperative Pharyngolaryngeal Morbidity Postoperative 1.Hour
|
1 units on a scale
Interval 1.0 to 4.0
|
1 units on a scale
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: Postoperative 24.hourPopulation: 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.
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
Outcome measures
| Measure |
Group Routine Care
n=45 Participants
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
|
Group Pressure Limiting
n=45 Participants
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)
|
|---|---|---|
|
Postoperative Pharyngolaryngeal Morbidity at Postoperative 24.Hour
|
1 units on a scale
Interval 1.0 to 3.0
|
1 units on a scale
Interval 1.0 to 1.0
|
Adverse Events
Group Routine Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group Pressure Limiting
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Anaesthesiology and Reanimation, Dr. Sule Ozbilgin
DorkuzEU
Phone: 0905055252901
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place