- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05574465
Esophageal Manometry During Recovery From Endotracheal Intubation
6 oktober 2022 uppdaterad av: University of California, San Francisco
- 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.
- In patients, while under medication to tolerate endotracheal intubation, it is postulated that an identifiable upper esophageal sphincter and esophageal peristalsis are not present.
- 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.
- 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
100
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: John P Cello, MD
- Telefonnummer: 628-206-4767
- E-post: john.cello@ucsf.edu
Studera Kontakt Backup
- Namn: Alex Rodas, MA
- Telefonnummer: 628-206-4746
- E-post: alex.rodas@ucsf.edu
Studieorter
-
-
California
-
San Francisco, California, Förenta staterna, 94143
- University of California, San Francisco
-
Huvudutredare:
- John P Cello, MD
-
Kontakt:
- Alex Rodas, MA
- Telefonnummer: 628-206-4746
- E-post: alex.rodas@ucsf.edu
-
Huvudutredare:
- Stanley J Rogers, MD
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Övrig: Manometry Device
At 10 minutes prior to anticipated removal of the endotracheal tube, pass the routine manometry catheter per naris to 30 cms.
|
The use of esophageal manometry device during removal of endotracheal tube by anesthesia
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
The Basal Pressures of patients during High-Resolution Motility/Manometry (HRM):
Tidsram: 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):
Tidsram: 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):
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Percentage of patients agreeing to study versus refusing study.
Tidsram: During enrollment
|
Percentage/number of patients/next of kin accepting protocol
|
During enrollment
|
Number of patients completing study.
Tidsram: At the completion of procedure
|
Percentage/number of patients completing esophageal motility/manometry study.
|
At the completion of procedure
|
Duration of HRM
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 juli 2025
Primärt slutförande (Förväntat)
30 juni 2027
Avslutad studie (Förväntat)
31 december 2027
Studieregistreringsdatum
Först inskickad
21 april 2022
Först inskickad som uppfyllde QC-kriterierna
6 oktober 2022
Första postat (Faktisk)
10 oktober 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 oktober 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 oktober 2022
Senast verifierad
1 oktober 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 22-36634
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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