Clinical Trials Logo
  1. Home
  2. Respiratory Insufficiency
  3. NCT01953484
  4. Details
NCT01953484 Clinical Trial

Changes in Spontaneous Ventilation in Response to Changes in Extracorporeal Carbon Dioxide Removal

Respiratory Insufficiency Clinical Trial

Official title:
Changes in Spontaneous Ventilation in Response to Changes in Extracorporeal Carbon Dioxide Removal

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01953484
Other study ID # VECLA-ECMO
Secondary ID
Status Recruiting
Phase N/A
First received September 9, 2013
Last updated October 14, 2013
Start date July 2013

Study information
Verified date October 2013
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact Luciano Gattinoni, Prof.
Phone +39-02-55033285
Email gattinon@policlinico.mi.it
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial Summary

In physiological conditions, spontaneous ventilation is controlled by blood carbon dioxide (and pH) levels. In healthy animals, extracorporeal carbon dioxide removal leads to hypoventilation or apnea (Kolobow et al., 1977). During acute respiratory insufficiency, extracorporeal carbon dioxide removal may be used to control spontaneous ventilation, limiting risks of lung damage and relieving dyspnea (Crotti et al., 2012). However, little is known about how spontaneous ventilation changes in response to changes in extracorporeal carbon dioxide removal during acute respiratory insufficiency, especially in humans.

Aim of this study is to monitor changes in spontaneous ventilation in awake patients treated with extracorporeal gas exchange support because of acute respiratory insufficiency, in response to changes in extracorporeal carbon dioxide removal.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Acute Respiratory Insufficiency

- Extracorporeal gas exchange support

- The patient is spontaneously breathing (including assisted ventilation)

Exclusion Criteria:

- age below 18 yrs

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Change in extracorporeal carbon dioxide removal

Locations
Country Name City State
Italy Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Milan

Sponsors (1)
Lead Sponsor Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Spontaneous ventilation Extracorporeal carbon dioxide removal will be increased or decreased changing the gas flow to the extracorporeal membrane lung. Actual extracorporeal carbon dioxide removal will be measured. Spontaneous respiratory rate, tidal volume, minute ventilation, esophageal pressure swings and comfort of the patient will be recorded 30-60 minutes after changing extracorporeal carbon dioxide removal. 30-60 minutes after changing extracorporeal carbon dioxide removal No
See also
  Status Clinical Trial Phase
Recruiting NCT05904652 - High Flow Nasal Oxygen at Extubation for Adults Requiring a Breathing Tube for Treating Severe Breathing Difficulties N/A
Completed NCT04030208 - Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation N/A
Recruiting NCT03697785 - Weaning Algorithm for Mechanical VEntilation N/A
Recruiting NCT02989051 - Fluid Restriction Keeps Children Dry Phase 2/Phase 3
Completed NCT02930525 - Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation N/A
Recruiting NCT02539732 - Prediction of Outcome of Weaning From Mechanical Ventilation Using the Electrical Activity of the Diaphragm
Enrolling by invitation NCT02290236 - Monitored Saturation Post-ICU N/A
Completed NCT02056119 - RCT of Mesh Versus Jet Nebulizers on Clinical Outcomes During Mechanical Ventilation in the Intensive Care Unit N/A
Terminated NCT01583088 - Early Stage Amyotrophic Lateral Sclerosis Phrenic Stimulation Phase 3
Withdrawn NCT00990119 - High Flow Therapy (HFT) to Treat Respiratory Insufficiency in Chronic Obstructive Pulmonary Disease (COPD) N/A
Completed NCT01411722 - Electrical Activity of the Diaphragm During the Weaning Period Phase 2
Completed NCT00741949 - Broncho-alveolar Lavage Under Noninvasive Ventilation With Propofol TCI in Patient With AHRF Phase 3
Recruiting NCT00339053 - Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair Phase 4
Recruiting NCT00187434 - Comparison of Two Methods of Continuous Positive Airway Pressure (CPAP) to Support Successful Extubation of Infants of Birth Weights ≤ 1500 Grams (C2CPAP) N/A
Completed NCT02687802 - Respiratory Mechanics and Patient-ventilator Asynchrony Index in Patients With Invasive Mechanical Ventilation
Not yet recruiting NCT05906030 - Diaphragm Dysfunction and Ultrasound Perioperatively
Completed NCT03850977 - Is There an Association Between Chronic Pancreatitis and Pulmonary Function
Completed NCT02845375 - Effect of Neuromuscular Blockade and Reversal on Breathing Phase 4
Recruiting NCT03309423 - Is Venous to Arterial Conversion (v-TAC) of Blood Gas Reliable in Critical Ill Patients in the ICU? N/A
Completed NCT04115969 - Outcome After Non-invasive Ventilation.