Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02894177
Other study ID # P15/07_ tcPCO2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 4, 2017
Est. completion date August 31, 2020

Study information

Verified date October 2023
Source Versailles Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Difficult weaning from ventilation and extubation failure are major issues in intensive care, concerning 30% and 12% of patients respectively. These can be partly explained by the lack of accuracy of spontaneous breathing trial (SBT) failure criteria to predict extubation failure. The investigators performed a pilot study to evaluate transcutaneous carbon dioxide pressure (tcPCO2) monitoring during SBTs. The results showed that the difference between maximum and initial tcPCO2 (or ΔtcPCO2) was significantly higher in the group of patients who failed SBTs according to the usual criteria. Moreover, the results suggested that ΔtcPCO2 could be an accurate and early criterion for SBT failure. The size of the study could not examine ΔtcPCO2 regarding extubation failure. Therefore, the main objective of this study is to determine if Δ tcPCO2 during SBTs is associated with extubation failure.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date August 31, 2020
Est. primary completion date April 2, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - > 18 years old, - ICU indicated - invasive mechanical ventilation via orotracheal or nasotracheal intubation - presence of criteria for initiation of the weaning process as stated on our ICU's protocol - resolution of the disease leading to mechanical ventilation Exclusion Criteria: - mechanical ventilation during less than 24 hours - Tracheotomy and tracheostomy at ICU admission - Pregnancy - Patient under legal protection - Patient enrolled in another study regarding weaning or CO2 metabolism

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
tcPCO2 measurement
tcPCO2 continuous monitoring during spontaneous breathing trials

Locations

Country Name City State
France CH Versailles Le Chesnay

Sponsors (1)

Lead Sponsor Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference between maximum and initial tcPCO2 (?tcPCO2) during SBTs in patients who fail extubation compared to patients who have been successfully extubated. Extubation failure: need for reintubation, rescue non invasive ventilation or death within 7 days following extubation 7 days
Secondary Association between ?tcPCO2 and extubation failure after adjustment on post extubation ventilation protocols (preventive non invasive ventilation or preventive Optiflow) Different post-extubation ventilation protocols may include preventive non invasive ventilation or Optiflow. 7 days
Secondary Association between extubation decisions and ?tcPCO2. 1 week
Secondary Adverse Events associated with tcPCO2 monitoring. 1 week
Secondary Optimal ?tcPCO2 threshold to predict extubation failure by a ROC curve. 7 days
Secondary Compare ROC curves obtained by different extubation failure predictors ROC curves obtained with:
usual SBT failure criteria
deltatcPCO2 alone
usual criteria and ?tcPCO2 combined
shallow breathing index
shallow breathing index and ?tcPCO2 combined
?tcPCO2, shallow breathing index and usual SBT failure criteria combined
7 days
Secondary Determine if ?tcPCO2 is an early predictor of extubation failure (happening before other criteria of failed SBT) 7 days
See also
  Status Clinical Trial Phase
Recruiting NCT05114551 - ICU Predictive Score of WEaning Success in Patients At Risk of Extubation Failure
Completed NCT04011852 - The Role of Chest Electrical Impedance Tomography in the Pediatric Ventilator Weaning
Recruiting NCT02921334 - Early Tracheotomy for Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning N/A
Recruiting NCT02921347 - Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning in Difficult-weaning Patients N/A
Recruiting NCT06055413 - Home-based Optimization of Mechanical Ventilation in Children N/A
Active, not recruiting NCT04023643 - Pediatric Ventilation Weaning N/A
Completed NCT05254691 - WOB and Paediatric Mechanical Ventilation N/A
Recruiting NCT05999526 - Mechanical Ventilation Reconnection for One Hour After Spontaneous Breathing Trial N/A
Active, not recruiting NCT02820090 - The Predictive Effect of the Inflammatory Response on the Evacuation of Mechanical Ventilation and the Mechanism N/A
Recruiting NCT01131377 - Acetazolamide Facilitates Ventilator Weaning N/A
Completed NCT02412202 - Echocardiographic Detection of Extravascular Lung Water Increase During Weaning From Mechanical Ventilation N/A
Completed NCT00445289 - Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units N/A
Recruiting NCT05380687 - Time Course of Neuro-ventilatory Efficiency During a Spontaneous Breathing Training N/A
Terminated NCT01535755 - A Protocol to Wean From Noninvasive Mechanical Ventilation N/A
Completed NCT04711759 - Physiologic Effects of High-flow Nasal Cannula Versus Standard Oxygen Therapy Postextubation in Critically Ill Patients N/A
Completed NCT03433105 - Oxygen Uptake in Weaning of Patients From Prolonged Mechanical Ventilation
Completed NCT00505804 - A Comparison of Dexmedetomidine and Haloperidol in Patients With Intensive Care Unit (ICU)-Associated Agitation and Delirium Phase 2
Completed NCT02946502 - Handgrip Strength Value in Predicting Mechanical Ventilation Weaning N/A
Completed NCT03673683 - Sedation and Weaning in Children Requiring Invasive Mechanical Ventilation N/A
Terminated NCT03019107 - Breath Synchronized Abdominal Muscle Stimulation to Facilitate Ventilator Weaning: a Pilot Study