AnaesthesiaPhase 4NCT02189954
Effect of Laryngeal Mask Cuff Pressure in Geriatric Patients
A Phase 4 study testing The placement according to the manufacturer's instructions and Cuff inner pressure was held below 44 mmHg in people with Anaesthesia, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anaesthesia
- What is being tested?
- The placement according to the manufacturer's instructions and Cuff inner pressure was held below 44 mmHg
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2011to Aug 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Above the age of 65
- ASA I-III
- Undergoing elective surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
Izmi̇r, 35320
About this study
Official title: Effect of Laryngeal Mask Cuff Pressure on Postoperative Pharyngolaryngeal Complications in Geriatric Patients
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.
Read the detailed description
This study received permission from Dokuz Eylül University Medical Faculty Non-Interventional Ethics Committee and informed consent was obtained from the patients. Ninety patients above the age of 65 with American Society of Anesthesiologists (ASA) physiological classification group I-III, undergoing elective surgery and with indications for laryngeal mask placement participated in this prospective, randomized and double blind study.
Patients taken to the operating room were given standard monitoring (ECG, pulse oxymetry, non-invasive blood pressure) and BIS monitoring [BIS-Vista ™ (Aspect Medical Systems, USA)] before anesthesia induction.
After patients were preoxygenated with 6 L/min oxygen through a face mask for 3 minutes anesthesia induction was provided by 0.02 mg/kg midazolam, 1-2 µg/kg fentanyl and 1-2 mg/kg propofol. During respiration Airway was not used, unless there was ventilation difficulty with the face mask. 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. The placement method was according to the manufacturer's instructions. All patients were respirated by a breathing circuit with heat and moisture filter.
After the laryngeal mask was inserted the cases were manually respirated so peak inspiratory pressure was less than 20 cmH2O and the cuff of both groups was inflated with a 20 ml injector until the leak sound ceased. To evaluate ventilation the capnogram showed square wave forms and the patients' chest movements were observed, in unsuccessful situations the procedure was repeated. During attempts depending on the patients' reactions and with the requirement of keeping BIS values between 40 and 60, an additional dose of 0.5 mg/kg propofol was administered.
After Laryngeal Mask was determined and when anesthetic depth was sufficient (BIS 40-60) the inner pressure of the LMU cuff was measured and recorded by a manometer (cuff pressure manometer, Rusch, Germany). Later groups were divided in two using a random number table. In the group with cuff pressure limitation (Group Pressure Limiting (PL), n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg), while the routine group (Group Routine Care, n=45) pressure was only recorded.
Anesthesia was maintained by 50% O2:50% air mix with 1.5-2.5% sevoflurane, with sevoflurane concentration and additional fentanyl doses arranged to keep BIS between 40 and 60. All patients were respirated with positive pressure ventilation tidal volume 7-8 ml/kg, inspiring: expiring rate 1:2, respiration frequency on the capnograph end tidal carbon dioxide held between 30-35 mmHg. Oropharyngeal leak pressure measurement was recorded as the pressure value when a leak sound was heard from the mouth after the expiring valve was closed and fresh gas flow was reduced to 3 L/min. Immediately after the laryngeal mask was inserted, every 5 minutes in the first half hour and every 15 minutes after that, tidal volume, mean airway pressure, end tidal carbon dioxide levels and peripheral oxygen saturation values were recorded. If the operation lasted more than one hour a second manometric measurement was taken and stable values were maintained.
After the operation, the LMU's were removed when the patients were awake and could open their mouths on an oral command and unless necessary, aspiration was not applied.After anesthesia the patients were monitored in the recovery unit and analgesia was provided by 5-10 mg intravenous dolantin titration. A researcher blind to the groups recorded throat pain, voice loss and difficulty swallowing in the 1st and 24th hour, classifying as Likert scale ranges from 1 (none) to 4 (severe). Cases developing rare complications of recurrent laryngeal nerve, hypoglossal nerve and lingual nerve paralysis were recorded. The cases were brought to the ward when Aldrete scoring criteria were appropriate. Cases discharged early from the ward had 24th hour evaluation by telephone communication.
- Conditions
- Anaesthesia
- Being tested
- The placement according to the manufacturer's instructions, Cuff inner pressure was held below 44 mmHg
- Keywords
- elderly; laryngeal masks; postoperative complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The placement according to the manufacturer's instructionsProcedure or surgery
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
Cuff inner pressure was held below 44 mmHgProcedure or surgery
cuff pressure limitation (Group Pressure Limiting (PL), n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)
| Study group | Role | What they receive |
|---|---|---|
| Group Routine Care | Active comparator | The placement according to the manufacturer's instructions. Receives: Procedure: The placement according to the manufacturer's instructions |
| Group Pressure Limiting | Experimental | Cuff inner pressure was held below 44 mmHg Receives: Procedure: Cuff inner pressure was held below 44 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Postoperative 1.hour
Secondary outcomes (1)
Postoperative Pharyngolaryngeal Morbidity at 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
Measured: Postoperative 24.hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sule Ozbilgin, Dokuz Eylul University
- Investigators
- FERİM GÜNENÇ, M.D., Principal investigator, Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189954
- Sponsor's protocol ID
- 269-GOA
- Status last verified
- Aug 2015
- First submitted
- 28 Jun 2014
- Last updated
- 31 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laryngeal Mask Cuff Pressure on Postoperative Pharyngolaryngeal Complications in Geriatric Patients
- ClinicalTrials.gov ID
- NCT02189954
- Acronym / sponsor ID
- 269-GOA
- Conditions
- Anaesthesia
- Keywords
- elderly; laryngeal masks; postoperative complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Posted 31 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study received permission from Dokuz Eylül University Medical Faculty Non-Interventional Ethics Committee and informed consent was obtained from the patients. Ninety patients above the age of 65 with American Society of Anesthesiologists (ASA) physiological classification group I-III, undergoing elective surgery and with indications for laryngeal mask placement participated in this prospective, randomized and double blind study.
Patients taken to the operating room were given standard monitoring (ECG, pulse oxymetry, non-invasive blood pressure) and BIS monitoring [BIS-Vista ™ (Aspect Medical Systems, USA)] before anesthesia induction.
After patients were preoxygenated with 6 L/min oxygen through a face mask for 3 minutes anesthesia induction was provided by 0.02 mg/kg midazolam, 1-2 µg/kg fentanyl and 1-2 mg/kg propofol. During respiration Airway was not used, unless there was ventilation difficulty with the face mask. 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. The placement method was according to the manufacturer's instructions. All patients were respirated by a breathing circuit with heat and moisture filter.
After the laryngeal mask was inserted the cases were manually respirated so peak inspiratory pressure was less than 20 cmH2O and the cuff of both groups was inflated with a 20 ml injector until the leak sound ceased. To evaluate ventilation the capnogram showed square wave forms and the patients' chest movements were observed, in unsuccessful situations the procedure was repeated. During attempts depending on the patients' reactions and with the requirement of keeping BIS values between 40 and 60, an additional dose of 0.5 mg/kg propofol was administered.
After Laryngeal Mask was determined and when anesthetic depth was sufficient (BIS 40-60) the inner pressure of the LMU cuff was measured and recorded by a manometer (cuff pressure manometer, Rusch, Germany). Later groups were divided in two using a random number table. In the group with cuff pressure limitation (Group Pressure Limiting (PL), n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg), while the routine group (Group Routine Care, n=45) pressure was only recorded.
Anesthesia was maintained by 50% O2:50% air mix with 1.5-2.5% sevoflurane, with sevoflurane concentration and additional fentanyl doses arranged to keep BIS between 40 and 60. All patients were respirated with positive pressure ventilation tidal volume 7-8 ml/kg, inspiring: expiring rate 1:2, respiration frequency on the capnograph end tidal carbon dioxide held between 30-35 mmHg. Oropharyngeal leak pressure measurement was recorded as the pressure value when a leak sound was heard from the mouth after the expiring valve was closed and fresh gas flow was reduced to 3 L/min. Immediately after the laryngeal mask was inserted, every 5 minutes in the first half hour and every 15 minutes after that, tidal volume, mean airway pressure, end tidal carbon dioxide levels and peripheral oxygen saturation values were recorded. If the operation lasted more than one hour a second manometric measurement was taken and stable values were maintained.
After the operation, the LMU's were removed when the patients were awake and could open their mouths on an oral command and unless necessary, aspiration was not applied.After anesthesia the patients were monitored in the recovery unit and analgesia was provided by 5-10 mg intravenous dolantin titration. A researcher blind to the groups recorded throat pain, voice loss and difficulty swallowing in the 1st and 24th hour, classifying as Likert scale ranges from 1 (none) to 4 (severe). Cases developing rare complications of recurrent laryngeal nerve, hypoglossal nerve and lingual nerve paralysis were recorded. The cases were brought to the ward when Aldrete scoring criteria were appropriate. Cases discharged early from the ward had 24th hour evaluation by telephone communication.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Routine Care | Active comparator | Procedure: The placement according to the manufacturer's instructionsThe placement according to the manufacturer's instructions. |
| Group Pressure Limiting | Experimental | Procedure: Cuff inner pressure was held below 44 mmHgCuff inner pressure was held below 44 mmHg |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Above the age of 65
- ASA I-III
- Undergoing elective surgery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The placement according to the manufacturer's instructionsBefore 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 | Procedure or surgery | Group Routine Care |
| Cuff inner pressure was held below 44 mmHgcuff pressure limitation (Group Pressure Limiting (PL), n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg) | Procedure or surgery | Group Pressure Limiting |
Primary outcome
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
1 secondary outcome
Postoperative Pharyngolaryngeal Morbidity at Postoperative 24.Hour
Time frame: Postoperative 24.hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FERİM GÜNENÇ, M.D. principal investigator
Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing The placement according to the manufacturer's instructions and Cuff inner pressure was held below 44 mmHg in people with Anaesthesia, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pharyngolaryngeal Morbidity Postoperative 1.Hour (time frame: Postoperative 1.hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2015.