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Prevention of Gastric Insufflation During Positive Pressure Ventilation ?

14. december 2017 opdateret af: Jean François Brichant, University of Liege

Is Ultrasound-guided Left Paratracheal Esophagus Pressure More Effective Than Cricoid Pressure to Prevent Gastric Insufflation During Positive Pressure Ventilation ?

Evaluation of a new method to prevent gastric insufflation

Studieoversigt

Status

Ukendt

Detaljeret beskrivelse

After Ethics Committee approval of the University of Liège and written informed consent, 90 ASA 1-2 patients aged 18-65 years and scheduled for elective surgery under general anesthesia will be enrolled in the study. Exclusion criteria are body mass index (BMI) above 35; meeting criteria for difficult ventilation and/or intubation, such as oropharyngeal pathology or facial or cervical abnormalities; and risk for aspiration or previous gastric surgery. Patients will be randomly allocated 1:1:1 (30 patients/group) by the method of sealed envelopes to left low paratracheal esophageal compression (LPEC), cricoid pressure (CP), or no pressure intervention (Control). Neck circumference will be measured. No premedication will be given prior to the study interventions.

Part 1: Ultrasound assessment of the esophagus at the left lower paratracheal level

Esophageal examinations will be conducted by ultrasound with the patient supine and head in neutral position. Feasibility of imaging and compressing the esophagus approximately 2-3 cm above the clavicle was assessed as follows:

A linear ultrasound probe (Applio XG iStyle Toshiba with a 14-7 Mhz) was positioned in a transverse (axial) orientation over the left paratracheal area (Figure 1(A)), 2-3 cm above the clavicle. The position of the esophagus in relation to the trachea (left, right or not seen) will be recorded. Once the esophagus will be identified, the antero-posterior diameter (mm) will be measured and compared before and after applying an estimated pressure of 30 N (as described below) or until a bony contact will be established with the transducer. Esophageal compression will be re-assessed using a paramedian sagittal plane between the trachea and the sternocleidomastoid muscle with the esophagus in sagittal plane. The antero-posterior diameter (mm) measurements will be repeated before and after applying pressure with the transducer. Three consecutive measures for each probe position were recorded.

Part 2: Assessment of the presence of gastric (antral) air With the patients in supine position, a curvilinear transducer (Applio XG iStyle Toshiba with an 8-5 MHz) will be placed on the epigastrium in a paramedian sagittal orientation to identify the antrum. 9 The cross-sectional area of the antrum was measured at the level where both the aorta and upper mesenteric artery were visible. Three consecutive measures were taken (a) before the induction of anesthesia and (b) after 3 min of PPV via face mask. The presence of gastric air insufflation is defined as an increase in cross-sectional area and/or presence of artifacts in the antrum (comet tail, posterior acoustic shadow). 9 These assessments will be performed by a sonographer, blinded to group allocation by a surgical drape placed between the thorax and the abdomen.

Pressure maneuvers Two anesthesiology residents, not informed of the study outcome measurements, will be trained to apply sustained pressure of 30 ± 5 N using an electronic dynamometer (MicroFET2; Hoogan Industries, West Jordan, Utah), until 10 consecutive maneuvers will be measured successfully (30 ± 5 N). For cricoid pressure, the cartilage will be compressed with the thumb and index fingers toward the vertebral bodies (Sellick). For LPEC, the thumb will be placed over the base of the neck on the left side of the trachea 2-3 cm above the clavicle and medial to the sternocleidomastoid muscle (Figure 1(B)).

ASA monitoring will be applied, and anesthesia will be induced with propofol 2.5 mg/kg administered over 45 sec. Remifentanil will be administered with an infusion pump (2 to 3 μg/kg over 60 sec during induction, followed by continuous infusion of 0.05μg /kg/min). After general anesthesia will be induced, PPV was accomplished with a face-mask in pressure-control mode while maintaining a positive inspiratory pressure of 25 cm H2O, (Zeus ventilator, Dräger, Lübeck, Germany). The ventilator settings will be 100% oxygen, I:E ratio 1:2, 15 breaths/min, no positive end-expiratory pressure. Adequacy of ventilation will be documented by chest raise and capnography. Antral measurements will be taken after 3 min of face-mask ventilation by a sonographer blinded to group assignment. Thereafter, the management of anesthesia care will be continued as per institutional standards.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

90

Kontakter og lokationer

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Studiesteder

    • Liege
      • Liège, Liege, Belgien, 4000
        • Rekruttering
        • CHU de Liege
        • Kontakt:
        • 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 til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

patients undergoing anesthesia under general anesthesia

Beskrivelse

Inclusion Criteria:

  • elective surgery under general anesthesia

Exclusion Criteria:

  • body mass index above 35 meeting criteria for difficult ventilation and /or intubation risk for aspiration or gastric surgery

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
control,
control normal ventilation
sellick,
ventilation while sellick manoeuvre is applied
low paratracheal esophagus compression
ventilation while low paratracheal esophagus compression is applied

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
gastric volume
Tidsramme: within 10 min of induction of anesthesia
With the patients in supine position, a curvilinear transducer (Applio XG iStyle Toshiba with an 8-5 MHz) will be placed on the epigastrium in a paramedian sagittal orientation to identify the antrum. The cross-sectional area of the antrum will be measured at the level where both the aorta and upper mesenteric artery will be visible
within 10 min of induction of anesthesia

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
diameter of the esophagus
Tidsramme: within 10 min of induction of anesthesia
A linear ultrasound probe (Applio XG iStyle Toshiba with a 14-7 Mhz) will be positioned in a transverse (axial) orientation over the left paratracheal area (Figure 1(A)), 2-3 cm above the clavicle. The position of the esophagus in relation to the trachea (left, right or not seen) will be recorded. When the esophagus will be identified, the antero-posterior diameter (mm) will be measured and compared before and after applying an estimated pressure of 30 N.
within 10 min of induction of anesthesia

Samarbejdspartnere og efterforskere

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Datoer for undersøgelser

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Studer store datoer

Studiestart (Faktiske)

22. marts 2017

Primær færdiggørelse (Forventet)

1. februar 2018

Studieafslutning (Forventet)

1. februar 2018

Datoer for studieregistrering

Først indsendt

14. december 2017

Først indsendt, der opfyldte QC-kriterier

14. december 2017

Først opslået (Faktiske)

20. december 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. december 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. december 2017

Sidst verificeret

1. december 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • ULGANESGAU001

Plan for individuelle deltagerdata (IPD)

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