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

Esophageal Manometry During Recovery From Endotracheal Intubation

6. oktober 2022 opdateret af: University of California, San Francisco
  1. An intact pharyngoesophageal reflex is essential to protect the upper airway from aspiration of either mouth contents or regurgitated gastric refluxate. This reflex is essential at protecting the airway in all patients.
  2. In patients, while under medication to tolerate endotracheal intubation, it is postulated that an identifiable upper esophageal sphincter and esophageal peristalsis are not present.
  3. With the cessation of anesthetics, accompanied by the reversal of nerve block, normal pharyngoesophageal peristaltic activity correlates with awakening the patient from anesthesia. This would be identified by the performance of esophageal manometry.
  4. A return of normal verbally stimulated pharyngoesophageal swallowing sequence accurately identifies a safe time to remove endotracheal tubes and/or reverse anesthesia. This verbally stimulated swallowing sequence correlated precisely with the return of objective pharyngoesophageal function.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The emergence from routine general deep anesthesia with an endotracheal tube is a potentially dangerous time for patients. Patients cannot reliably maintain competence of the upper esophageal sphincter, thus aspiration of the contents from the mouth or regurgitated material from the stomach can be aspirated into the lungs leading to serious complications. In normal awake individuals the upper esophageal sphincter (also known as the cricopharyngeus or the inferior pharyngeal constrictor) is contracted and relaxes precisely timed with voluntary or involuntary swallowing. The swallowing sequence in normal awake persons begins with 1) the contraction of the upper and middle pharyngeal constrictors, 2) the posterior movement of the tongue and 3) the prompt relaxation of the contracted upper esophageal sphincter. Peristalsis then begins in the body of the esophagus leading contents to the stomach. The above is the normal sequence in humans, a process which maintains absolute separation of the airway and digestive passageways despite being in intimate proximity. During the early period of emergence from anesthesia, the aspiration risk is highest due to the sluggish return of the resting pressure in the upper esophagus and the lack of normal coordination with involuntary swallowing. Thus patients can't protect their airway by maintaining competence and appropriate relaxation of the upper esophageal sphincter. Routine high resolution solid state manometry is a standard routine technique is currently performed in awake patients sitting upright voluntarily requested to swallow small boluses of liquid. The entire sequence of events is studied using high resolution solid state manometry.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94143
        • University of California, San Francisco
        • Ledende efterforsker:
          • John P Cello, MD
        • Kontakt:
        • Ledende efterforsker:
          • Stanley J Rogers, MD

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 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients between 18 and 70 years of age (ASA I or II).
  • Already scheduled for endotracheal tube extubation.
  • Willing and able to give informed consent in either English or Spanish.

Exclusion Criteria:

  • Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
  • Patients not meeting entry criteria above.
  • Refusal to give informed consent.
  • Coagulopathy (INR > 2 and/or platelet count < 100,000.
  • White Blood Cell count < 5,000/mm3
  • Arrhythmia
  • Serum creatinine > 2 mg/dl
  • Prior known or suspected nasal obstruction.
  • Known or suspected Zenker's diverticulum of esophagus, esophageal stricture, head/neck radiation therapy, hereditary telangiectasis, esophageal varices, cirrhosis.
  • Anticoagulant usage such as heparin or Plavix

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Manometry Device
At 10 minutes prior to anticipated removal of the endotracheal tube, pass the routine manometry catheter per naris to 30 cms.
Enhed: High resolution solid state manometry
The use of esophageal manometry device during removal of endotracheal tube by anesthesia

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Basal Pressures of patients during High-Resolution Motility/Manometry (HRM):
Tidsramme: The change in Basal Pressures will be recorded at the end of procedure.

High-resolution manometry (HRM) determination of return of cricopharyngeal function

- Basal Pressures: Upper esophageal sphincter (mmHg) - normal (34-104)
The change in Basal Pressures will be recorded at the end of procedure.
The Residual Pressures of patients during High-Resolution Motility/Manometry (HRM):
Tidsramme: The change in Residual Pressures will be recorded at the end of procedure.
- Residual Pressures: Upper esophageal sphincter (mmHg) - normal (<12.0)
The change in Residual Pressures will be recorded at the end of procedure.
The Wave Duration of patients during High-Resolution Motility/Manometry (HRM):
Tidsramme: The change in Wave Duration will be recorded at the end of procedure.
- Motility: Wave Duration (seconds) - normal (2.7-5.4)
The change in Wave Duration will be recorded at the end of procedure.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of patients agreeing to study versus refusing study.
Tidsramme: During enrollment
Percentage/number of patients/next of kin accepting protocol
During enrollment
Number of patients completing study.
Tidsramme: At the completion of procedure
Percentage/number of patients completing esophageal motility/manometry study.
At the completion of procedure
Duration of HRM
Tidsramme: The HRM study of the cricopharyngeus will be measured for the 5 minute time period just before planned endotracheal extubation to the time during extubation and for the 5 minute period just after endotracheal extubation.
Duration (minutes) of motility/manometry research study during withdrawal of endotracheal intubation.
The HRM study of the cricopharyngeus will be measured for the 5 minute time period just before planned endotracheal extubation to the time during extubation and for the 5 minute period just after endotracheal extubation.

Samarbejdspartnere og efterforskere

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

Sponsor

University of California, San Francisco

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 (Forventet)

1. juli 2025

Primær færdiggørelse (Forventet)

30. juni 2027

Studieafslutning (Forventet)

31. december 2027

Datoer for studieregistrering

Først indsendt

21. april 2022

Først indsendt, der opfyldte QC-kriterier

6. oktober 2022

Først opslået (Faktiske)

10. oktober 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. oktober 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. oktober 2022

Sidst verificeret

1. oktober 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 22-36634

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

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 Motilitetsfunktion

Kliniske forsøg med High resolution solid state manometry

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Morocco

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner