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

Intubation Complication Clinical Trial

Official title:

Effect of Applying Cuff Air Leak Pressure as Intraoperative Cuff Pressure on Postoperative Complications: Prospective Randomized Control Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04302142
• Other study ID #: HSC-MS-20-0018
• Status: Withdrawn
• Phase: N/A
• Start date: June 2021
• Est. completion date: June 2021

Study information

• Verified date: August 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation Complication
• Postoperative Complications

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimum intracuff pressure at which there is no air leak around the cuff.		during surgery
Secondary	Number of patients with postoperative sore throat as measured by a standardized questionnaire	The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe	30 minutes post extubation
Secondary	Number of patients with postoperative sore throat as measured by a standardized questionnaire	The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe	2 hours post extubation
Secondary	Number of patients with postoperative sore throat as measured by a standardized questionnaire	The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe	24 hours post extubation
Secondary	Number of patients with postoperative coughing as measured by a standardized questionnaire	The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe	30 minutes post extubation
Secondary	Number of patients with postoperative coughing as measured by a standardized questionnaire	The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe	2 hours post extubation
Secondary	Number of patients with postoperative coughing as measured by a standardized questionnaire	The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe	24 hours post extubation
Secondary	Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire	The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe	30 minutes post extubation
Secondary	Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire	The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe	2 hours post extubation
Secondary	Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire	The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe	24 hours post extubation
Secondary	Number of patients with postoperative aspiration as measured by a standardized questionnaire	The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe	30 minutes post extubation
Secondary	Number of patients with postoperative aspiration as measured by a standardized questionnaire	The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe	2 hours post extubation
Secondary	Number of patients with postoperative aspiration as measured by a standardized questionnaire	The questionnaire utilizes a 4 point scale ,0 being mild and 3 being severe	24 hours post extubation