Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Ventilation and Gastric Insufflation During Three Levels of Inspiratory Pressure During Mask Ventilation

10. september 2021 opdateret af: Maha Mostafa Ahmad, MD, Kasr El Aini Hospital

Evaluation of Adequacy of Ventilation and Gastric Insufflation During Three Levels of Inspiratory Pressure for Pressure-controlled Mask Ventilation During Induction of Anesthesia: a Randomized Controlled Study

Pulmonary aspiration of gastric contents is one of the leading causes of general anesthesia-related mortality. Gastric insufflation during positive pressure mask ventilation increases the gastric volume, and consequently the risk of regurgitation. Thus, positive pressure mask ventilation should be avoided during rapid sequence induction of anesthesia when full-stomach is suspected (e.g. inadequate fasting hours, gastrointestinal obstruction, delayed gastric emptying, and lower esophageal disease) Although avoidance of positive pressure mask ventilation during induction would potentially minimize the risk of aspiration, this would lead to rapid hypoxia . Hence, finding a proper regimen for mask ventilation would avoid hypoxia which might be serious in high-risk patients.

Pressure-controlled face mask ventilation previously proved to be the least regimen to cause gastric insufflation in comparison to manual, and volume-controlled mask ventilation during induction of anesthesia. Later, a pressure of 15 cmH2O during face mask ventilation had been reported optimum to achieve the balance between adequate ventilation and reduced gastric insufflation in non-paralyzed patients. This finding was not yet replicated in paralyzed patients who represent the majority of population who receive mask ventilation during induction of anesthesia. We hypothesize that in paralyzed patient, the optimum pressure during face mask ventilation might be lower than the pressure which was previously reported in non-paralyzed patients. However, no studies to the best of our knowledge had confirmed this hypothesis.

Gastric insufflation was previously evaluated using auscultation with stethoscope, microphone placed in the epigastric area, or esophageal manometry. Recently, gastric antrum ultrasound was used successfully to gastric insufflation in real time by measuring the cross sectional area of gastric antrum before and after face mask ventilation. This newly developed method is more sensitive than the auscultatory method and less invasive than esophageal manometry method.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Upon arrival to the operating room, routine monitors (ECG, pulse oximetry, and non-invasive blood pressure monitor) will be applied, intravenous line will be secured, and routine pre-medications (ranitidine 50 mg and midazolam 3-5 mg) will be administrated. End-tidal CO2 monitoring will be initiated after induction of general anesthesia and starting face-mask ventilation. Induction of anesthesia will be achieved using fentanyl (2 mcg/Kg), propofol (2 mg/Kg), and rocuronium (0.6 mg/Kg). After loss of verbal response, mask ventilation will be achieved by appropriate size face mask and oropharyngeal airway with 100% oxygen and double hand jaw thrust head tilt maneuver. The included patients will be randomly allocated to receive the assigned pressure-controlled mask ventilation. The 3 study groups will receive the planned inspiratory pressure, without positive end-expiratory pressure, with a respiratory rate of 15, and inspiratory to expiratory ratio of 1:2 for 180 seconds.

Assessment gastric insufflation during mask ventilation will be achieved by ultrasound assessment of gastric antrum (in the sagittal plane between left lobe of the liver and pancreas at level of the aorta) and auscultation by two blinded investigators to the assigned pressure. The ultrasound screen will be positioned to be not visible to the investigator responsible for auscultation. Gastric insufflation will be identified by comet-tail sign by gastric ultrasound and gurgling sound by auscultation.

Gastric antrum cross sectional area [ D1(longitudinal diameter) X D2 (anteroposterior diameter) X π /4] in between contractions in supine position before face mask ventilation and after insertion of endotracheal tube will be recorded. gastric insufflation will be identified if gastric antrum cross sectional area increased by > 30% after endotracheal intubation in relation to the baseline.

During mask ventilation, the following parameter will be recorded at 30, 60, 90,120, 150 and 180 seconds; peripheral oxygen saturation, the end-tidal carbon dioxide concentration , peak airway measured pressure, and tidal volume Demographic data (age, sex, weight, height, BMI, comorbidities) will be recorded.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

111

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Egypten
      • Cairo, Egypten, 11562
        • Rekruttering
        • Kasr Alaini hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • adult patients (above 18 years)
  • American society of anesthesiologist I-II
  • scheduled for elective non-cardiac surgery under general anesthesia

Exclusion Criteria:

  • increased risk of difficult mask ventilation
  • patients at risk of aspiration
  • Patients with craniofacial anomalies
  • BMI >35 kg/m2
  • pregnant patients

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: pressure 10
mask ventilation with peak inspiratory pressure of 10 cmH2O
Andet: peak inspiratory pressure 10 cmH2O
pressure controlled mask ventilation with peak inspiratory pressure of 10 cmH2O
Aktiv komparator: pressure 15
mask ventilation with peak inspiratory pressure of 15 cmH2O
Andet: peak inspiratory pressure 15 cmH2O
pressure controlled mask ventilation with peak inspiratory pressure of 15 cmH2O
Aktiv komparator: pressure 20
mask ventilation with peak inspiratory pressure of 20 cmH2O
Andet: peak inspiratory pressure 20 cmH2O
pressure controlled mask ventilation with peak inspiratory pressure of 20 cmH2O

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
incidence of gastric insufflation by ultrasonography
Tidsramme: within 1 minute after endotracheal intubation
gastric antrum cross sectional area increased by > 30% after endotracheal intubation in relation to the baseline
within 1 minute after endotracheal intubation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gastric antrum cross sectional area
Tidsramme: 1 minute before mask ventilation and within 1 minute after endotracheal intubation
gastric antrum longitudinal diameter X anteroposterior diameter X π /4 in between contractions in supine position
1 minute before mask ventilation and within 1 minute after endotracheal intubation
tidal volume
Tidsramme: at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
mL
at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
endtidal CO2
Tidsramme: at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
mmHg
at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
peripheral O2 saturation
Tidsramme: at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
percentage
at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
incidence of gastric insufflation by auscultation
Tidsramme: 1 minute after onset of mask ventilation
gurgling sound by stethoscope
1 minute after onset of mask ventilation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kasr El Aini Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

9. september 2021

Primær færdiggørelse (Forventet)

1. december 2021

Studieafslutning (Forventet)

1. december 2021

Datoer for studieregistrering

Først indsendt

19. august 2021

Først indsendt, der opfyldte QC-kriterier

19. august 2021

Først opslået (Faktiske)

25. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. september 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2021

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MD-250-2019

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Maveinsufflation

Kliniske forsøg med peak inspiratory pressure 10 cmH2O

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Saudi Arabia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner