The Effect of Endotracheal Tube Cuff Deflation at Different Train-of-Four Values on Bucking Against the Tube (TOF-BUCK)
The Effect of Endotracheal Tube Cuff Deflation at Different Train-of-Four Values on Involuntary Bucking Against the Tube: A Prospective, Randomized Controlled Study
This prospective, randomized controlled trial investigates the effect of deflating the endotracheal tube cuff at different Train of Four (TOF) recovery levels on the incidence of bucking (involuntary respiratory efforts and coughing against the tube) during emergence from general anesthesia. The study includes 60 patients scheduled for cholecystectomy procedures. Participants are randomly assigned to two distinct groups based on the predetermined TOF ratio at which their endotracheal tube cuff pressure is reduced prior to extubation. The primary objective is to determine if timing the cuff deflation according to objective neuromuscular monitoring minimizes airway complications and enhances overall patient safety and comfort. Secondary objectives include evaluating the effects of this intervention on hemodynamic stability and the incidence of postoperative nausea and vomiting.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients aged between 18 and 65 years
- Patients scheduled for cholecystectomy surgery
- Patients requiring tracheal intubation
- Patients successfully intubated on the first attempt and in less than 30 seconds.
- American Society of Anesthesiologists (ASA) physical status I or II.
- General anesthesia duration of less than 3 hours.
- Body Mass Index (BMI) < 30.
Exclusion Criteria:
- Patients who refuse to participate in the study
- Patients outside the specified age range
- Patients presenting with signs of a difficult airway.
- Patients with an increased risk of perioperative aspiration
- American Society of Anesthesiologists (ASA) physical status III, IV, V, or VI.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Group 1: TOF Ratio > 0.9
In this group, the endotracheal tube cuff is deflated when the patient's Train-of-Four (TOF) ratio reaches > 0.9 |
The procedure involves the deflation of the endotracheal tube cuff prior to extubation during emergence from general anesthesia. |
|
Experimentell: Group 2: TOF Ratio 0.75-0.85
In this group, the endotracheal tube cuff is deflated when the patient's Train-of-Four (TOF) ratio is between 0.75 and 0.85 |
The procedure involves the deflation of the endotracheal tube cuff prior to extubation during emergence from general anesthesia. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of Bucking
Tidsram: From endotracheal tube cuff deflation up to 1 hour
|
The number of participants experiencing involuntary respiratory efforts, coughing, or bucking against the endotracheal tube during the emergence phase from general anesthesia. |
From endotracheal tube cuff deflation up to 1 hour
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 2025.104.05.18
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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 .