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

NCT ID: NCT04302142

Last Updated: 2022-09-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2021-06-30

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.

Conditions

Intubation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

Group Type: EXPERIMENTAL

ventilation with critical intracuff pressure (Pcr)

Intervention Type: DEVICE

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.

Control Group

Group Type: PLACEBO_COMPARATOR

ventilation with critical intracuff pressure (Pcr)

Intervention Type: DEVICE

Pcr is obtained just as it is done in the intervention group. The cuff will then be reinsufflated to the actual cuff pressure the care team initially chose. The care team will be blinded to the measured critical cuff pressures and hence will maintain the usual level of intracuff pressure in the control group during the entire anesthesia time.

Interventions

ventilation 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.

Intervention Type: DEVICE

ventilation with critical intracuff pressure (Pcr)

Pcr is obtained just as it is done in the intervention group. The cuff will then be reinsufflated to the actual cuff pressure the care team initially chose. The care team will be blinded to the measured critical cuff pressures and hence will maintain the usual level of intracuff pressure in the control group during the entire anesthesia time.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Yandong Jiang

Visiting Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yandong Jiang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-20-0018

Identifier Type: -

Identifier Source: org_study_id