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Effect of Laryngeal Mask Cuff Pressure in Geriatric Patients

5. srpna 2015 aktualizováno: Sule Ozbilgin, Dokuz Eylul University

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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

90

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Izmi̇r, Krocan, 35320
        • Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

65 let a starší (Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Promítání
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Group Routine Care
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
Experimentální: Group Pressure Limiting
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)

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Postoperative Pharyngolaryngeal Morbidity Postoperative 1.Hour
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Postoperative Pharyngolaryngeal Morbidity at Postoperative 24.Hour
Časové okno: 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
Postoperative 24.hour

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: FERİM GÜNENÇ, M.D., Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. července 2011

Primární dokončení (Aktuální)

1. července 2012

Dokončení studie (Aktuální)

1. srpna 2012

Termíny zápisu do studia

První předloženo

28. června 2014

První předloženo, které splnilo kritéria kontroly kvality

11. července 2014

První zveřejněno (Odhad)

15. července 2014

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

31. srpna 2015

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

5. srpna 2015

Naposledy ověřeno

1. srpna 2015

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 269-GOA

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