Sevoflurane in Chronic Obstructive Pulmonary Disease Exacerbation

Not Applicable

Terminated

• Conditions: Invasive Mechanical Ventilation; COPD Exacerbation
• Interventions: Drug: Sevoflurane; Drug: Propofol

• Registration Number: NCT03460015
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Prospective, open-label, single-center, study to investigate the effect of sevoflurane sedation compared to a propofol-controlled arm during COPD exacerbation requiring invasive mechanical ventilation in ICU.

Primary outcome measure:

Evolution of airway resistance before and after sevoflurane in COPD patients,

Secondary outcomes measures:

Respiratory mechanics (Maximum pressure, PEEPi and PEEPtot, trapped volume), Gas exchange by the help of blood gases, The heterogeneity of alveolar ventilation by electro-impedancemetry, Evolution of pulmonary inflammation, Trophicity and contractility of the diaphragm,

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-01
• Study Start: 2018-03-01
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-09
• Primary Completion: 2020-09-19
• Study Completion: 2020-12-16
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-23
• Last Update Posted: 2021-12-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane group	Sevoflurane	-
Sevoflurane group	Propofol	-
Propofol group	Propofol	-

Primary Outcome Measures

Name	Time	Method
Evolution of airway resistance before and after sevoflurane in COPD patients	Hour 48	Total airway resistance will be measured using the ventilator by setting a 5s inspiratory pause and to measure the sum of (Pmax-P1)/Flow + (P1-Pplat)/Flow. The mechanical ventilation setting will be standardised during the study period and will be similar between the two groups.

Secondary Outcome Measures

Name	Time	Method
Maximum pressure	Evolution between Hour 0 and Hour 48
PEEPi	Evolution between Hour 0 and Hour 48
PEEPtot	Evolution between Hour 0 and Hour 48
Heterogeneity of alveolar ventilation by electro-impedancemetry	Evolution between Hour 0 and Hour 48
Thickness of the diaphragm measured by ultrasound	Evolution between Hour 0 and Hour 48
Trapped volume	Evolution between Hour 0 and Hour 48
Gas exchange by the help of blood gases	Evolution between Hour 0 and Hour 48
Proinflammatory cytokines (IL1, IL6, TNFalpha) and sRAGE measurements in miniBroncho-Alveolar lavages	Evolution between Hour 0 and Hour 48

Trial Locations

Locations (1)

University hospital; 🇫🇷 Montpellier, Hérault, France