Effects of Different Postures and Ventilator Flow Waveforms on the Cuff Leak Test

Effects of Different Postures and Ventilator Flow Waveforms on the Cuff Leak Test: A Prospective Cohort Study

the purpose of this study is to analyzes the factors influencing the results of cuff leak test, in order to improve the cuff leak test on the accuracy of the prediction on airway edema after extubation.

Study Overview

• Status: Completed
• Conditions: Cuff Leak Volume
• Intervention / Treatment: Behavioral: Position, waveform

• Study Type: Observational
• Enrollment (Actual): 143

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Beijing Chao Yang Hospital RICU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients in RICU of Beijing chaoyang hospital with tracheal intubation

Description

Inclusion Criteria:

• Intubation less than 24 hours before amitting respiratory intensive care unit;

Exclusion Criteria:

• unstable hemodynamics;PEEP≥10cmH2O or FiO2≥0.8

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

observation; this study measure the cuff leak volume and cuff leak ratio according to the cuff leak test with different positions and waveform,, at the same time observe the patient general condition, vital signs, oxygen saturation, cuff leak test results under different conditions and the breathing machine parameters, the diameter of the airway, the use of sedatives and hormones, after extubation stridor and intubation is happening again, the use of NPPV after extubation, patient outcomes

Behavioral: Position, waveform; different positions and waveform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-extubation stridor	Inspiratory stridor within 48 hours of extubation and was usually associated with respiratory distress	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extubation failure due to PES	the need for reintubation in the 48 hours following extubation in a patient with post-extubation stridor.	48 hours

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital
• Investigators: Study Director: Huiwen Chu, bachelor, Beijing Chao Yang Hospital

Publications and helpful links

General Publications

• Prinianakis G, Alexopoulou C, Mamidakis E, Kondili E, Georgopoulos D. Determinants of the cuff-leak test: a physiological study. Crit Care. 2005 Feb;9(1):R24-31. doi: 10.1186/cc3012. Epub 2004 Nov 29.
• Kemper KJ, Benson MS, Bishop MJ. Predictors of postextubation stridor in pediatric trauma patients. Crit Care Med. 1991 Mar;19(3):352-5. doi: 10.1097/00003246-199103000-00012.
• Potgieter PD, Hammond JM. "Cuff" test for safe extubation following laryngeal edema. Crit Care Med. 1988 Aug;16(8):818. doi: 10.1097/00003246-198808000-00020. No abstract available.
• El-Orbany M, Salem MR. Endotracheal tube cuff leaks: causes, consequences, and management. Anesth Analg. 2013 Aug;117(2):428-34. doi: 10.1213/ANE.0b013e318292ee21. Epub 2013 Jun 6.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2015
• Primary Completion (Actual): March 29, 2019
• Study Completion (Actual): April 2, 2019

Study Registration Dates

• First Submitted: November 13, 2015
• First Submitted That Met QC Criteria: December 3, 2015
• First Posted (Estimate): December 8, 2015

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 11, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Cuff leak test, relative factors
• Other Study ID Numbers: Bei Jing Chao Yang Hospital