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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Bucking
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2025.104.05.18
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