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

Not Applicable

Withdrawn

• Conditions: Intubation Complication
• Interventions: Device: ventilation with critical intracuff pressure (Pcr)

• Registration Number: NCT04302142
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-10
• Study Start: 2021-06
• Primary Completion: 2021-06
• Study Completion: 2021-06
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-26
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	ventilation with critical intracuff pressure (Pcr)	-
Intervention group	ventilation with critical intracuff pressure (Pcr)	-

Primary Outcome Measures

Name	Time	Method
Minimum intracuff pressure at which there is no air leak around the cuff.	during surgery

Secondary Outcome Measures

Name	Time	Method
Number of patients with postoperative sore throat as measured by a standardized questionnaire	24 hours 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	24 hours 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	24 hours 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	24 hours post extubation	The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States