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

NCT04302142 | Withdrawn FDA Device

• 1 other identifier: HSC-MS-20-0018
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

anesthesia; endotracheal tube cuff pressure

Outcome Measures

Primary Outcomes (1)

• Minimum intracuff pressure at which there is no air leak around the cuff.

  during surgery

Secondary Outcomes (12)

• Number of patients with postoperative sore throat as measured by a standardized questionnaire

  30 minutes post extubation

• Number of patients with postoperative sore throat as measured by a standardized questionnaire

  2 hours post extubation

• Number of patients with postoperative sore throat as measured by a standardized questionnaire

  24 hours post extubation

• Number of patients with postoperative coughing as measured by a standardized questionnaire

  30 minutes post extubation

• Number of patients with postoperative coughing as measured by a standardized questionnaire

  2 hours post extubation

Study Arms (2)

Intervention group

EXPERIMENTAL

Device: ventilation with critical intracuff pressure (Pcr)

Control Group

PLACEBO COMPARATOR

Device: ventilation with critical intracuff pressure (Pcr)

Interventions

ventilation with critical intracuff pressure (Pcr) 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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Polymerase Chain Reaction

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Officials

• Yandong Jiang, MD,PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Professor

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 10, 2020
• Study Start: June 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)