Effect of Applying Cuff Air Leak Pressure as Intraoperative Cuff Pressure on Postoperative Complications

The University of Texas System (UT)

Status: Withdrawn

Conditions: Intubation Complication

Treatments: Device: ventilation with critical intracuff pressure (Pcr)

Study type: Interventional

Funder types: Other

Identifiers

NCT04302142

HSC-MS-20-0018

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Treatment:

Device: ventilation with critical intracuff pressure (Pcr)

Device: ventilation with critical intracuff pressure (Pcr)

Control Group

Placebo Comparator group

Treatment:

Device: ventilation with critical intracuff pressure (Pcr)

Device: ventilation with critical intracuff pressure (Pcr)