Intubation Complication
Conditions
Keywords
anesthesia, endotracheal tube cuff pressure
Brief summary
The purpose of the study is to achieve effective ventilation with critical intracuff pressure (Pcr) and determine if application of Pcr reduces the risks associated with over-insufflation of endotracheal cuff including postoperative sore throat, cough,nausea, vomiting, aspiration, and pneumonia.
Interventions
DEVICEventilation with critical intracuff pressure (Pcr)
Once the intra-cuff pressure is measured and recorded, the cuff will be deflated by drawing the air 0.5ml per step with each step lasting 3 breaths until a leak, in which a 10% reduction in expiratory volume over the inspiratory tidal volume, is detected.Cuff will then be reinflated until the expiratory tidal volume reaches the inspiratory tidal volume and the discrepancy between the inspiratory and expiratory tidal volume is less than 10 percent. If the intra-cuff pressure applied by the anesthesia care team is inadequate and the discrepancy between the inspiratory and expiratory tidal volume is 10% or greater, the cuff will be further inflated with air 0.5ml per step with each step lasting 3 breaths until it reaches Pcr. This Pcr will be maintained during the entire anesthesia time until extubation.During the course of surgery, if any leak is detected, the cuff will be re-inflated by 0.5ml of air until the leak is not detectable.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Elective Surgery under general anesthesia requiring endotracheal tube with mechanical ventilation and expected anesthesia duration of at least 2 hours. * No contra-indication for intra-operative volume controlled mechanical ventilation * Flat supine surgeries without expected positional adjustments * American Society of Anesthesiologists (ASA) physical status I-III
Exclusion criteria
* Use of Nitrous Oxide * BMI \> 40 * Ventilation through Nasal intubation or Tracheostomy * Preexisting sore throat, coughing, nausea/vomiting * Recent history of upper respiratory infection * Pregnancy * Expected to be kept intubated after surgery completion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimum intracuff pressure at which there is no air leak around the cuff. | during surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with postoperative sore throat as measured by a standardized questionnaire | 30 minutes post extubation | The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe |
| Number of patients with postoperative coughing as measured by a standardized questionnaire | 30 minutes post extubation | The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe |
| Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire | 30 minutes post extubation | The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe |
| Number of patients with postoperative aspiration as measured by a standardized questionnaire | 30 minutes post extubation | The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe |
Countries
United States
Outcome results
None listed