Clinical trial NCT04302142: Effect of Applying Cuff Air Leak Pressure as Intraoperative Cuff Pressure on Postoperative Complications
Official title: Effect of Applying Cuff Air Leak Pressure as Intraoperative Cuff Pressure on Postoperative Complications: Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Intubation Complication
Keywords: anesthesia
endotracheal tube cuff pressure
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Minimum intracuff pressure at which there is no air leak around the cuff.
timeFrame: during surgery
Secondary outcomes:
measure: Number of patients with postoperative sore throat as measured by a standardized questionnaire
timeFrame: 30 minutes post extubation
measure: Number of patients with postoperative sore throat as measured by a standardized questionnaire
timeFrame: 2 hours post extubation
measure: Number of patients with postoperative sore throat as measured by a standardized questionnaire
timeFrame: 24 hours post extubation
measure: Number of patients with postoperative coughing as measured by a standardized questionnaire
timeFrame: 30 minutes post extubation
measure: Number of patients with postoperative coughing as measured by a standardized questionnaire
timeFrame: 2 hours post extubation
measure: Number of patients with postoperative coughing as measured by a standardized questionnaire
timeFrame: 24 hours post extubation
measure: Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire
timeFrame: 30 minutes post extubation
measure: Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire
timeFrame: 2 hours post extubation
measure: Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire
timeFrame: 24 hours post extubation
measure: Number of patients with postoperative aspiration as measured by a standardized questionnaire
timeFrame: 30 minutes post extubation
measure: Number of patients with postoperative aspiration as measured by a standardized questionnaire
timeFrame: 2 hours post extubation
measure: Number of patients with postoperative aspiration as measured by a standardized questionnaire
timeFrame: 24 hours post extubation
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Yandong Jiang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: