Respiration, ArtificialNCT00853060
Energy Expenditure in Weaning From Mechanical Ventilation
An observational study of Respiration, Artificial and Energy Metabolism, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
During weaning from mechanical ventilation process, the energy expenditure in T tube is greater than pressure support ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration, Artificial, Energy Metabolism
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2006to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with respiratory failure receiving MV fore more than 24 hours, who had been admitted to the Intensive Care Unit (ICU) of the Hospital de Clínicas de Porto Alegre and who met the criteria for weaning from MV according to the parameters previously defined were selected to participate in the study.
Who may be able to join
- Patients with acute respiratory failure receiving MV for over 24 hours, in the ICU of the Hospital de Clínicas de Porto Alegre
Who cannot join
- Patients with chest drainage, hemodynamic instability (characterized by the use of vasoactive drugs), renal failure, mental status change, agitation, sudoresis, tachycardia, axillary temperature above 38°C and inspiratory oxygen fraction (FiO2) over 0.6.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio Grande do Sul/Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
Official title: Energy Expenditure During Weaning From Mechanical Ventilation: Is There Any Difference Between Pressure Support and T-Tube?
During weaning from mechanical ventilation process, the energy expenditure in T tube is greater than pressure support ventilation.
Read the detailed description
The energy expenditure (EE) was measured during the two periods of 30-minutes, with the 10 first minutes being discarded for analysis purposes. The other variables were recorded and monitored during the 10th and the 30th minute, in both pressure support (PS) and t-Tube (TT) modes. Patients were randomized in terms of sequence selection: PS - TT or TT - PS. In the baseline period, patients were receiving mechanical ventilation (Servo 900C and Servo 300; Siemens-Elema, Solna, Sweden), with PS ranging from 10 to 15cmH2O. During the PS mode, patients received assisted pressure ventilation of 10 cmH2O, 5 cmH2O of final positive expiratory pressure, the sensitivity of -1cmH2O and FiO2 of 0.4. During TT mode, oxygen flow was delivered in order to keep the same FiO2 that was provided in PS (0.4) as controlled by monitor screen (Datex Ohmeda S/5 - Compact Airway Module, M-COVX model, Finland). In this mode, an extensor was employed, one end of which was connected to the oxygen-enriched and the other end was secured to a 3-output ("T") connector, which was attached to the patient's ventilatory prosthesis. During the rest period (30 minutes), patients returned to the mechanical ventilation parameters utilized in the baseline period.
- Conditions
- Respiration, Artificial, Energy Metabolism
- Keywords
- energy expenditure, mechanical ventilation, weaning, pressure support ventilation, T-tube
- Medical subject headings
- Respiratory Aspiration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startMar 2006
- Primary completionMar 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration, ArtificialStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Silvia Vieira, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853060
- Sponsor's protocol ID
- 04-415
- Status last verified
- Feb 2009
- First submitted
- 25 Feb 2009
- Last updated
- 27 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Expenditure During Weaning From Mechanical Ventilation: Is There Any Difference Between Pressure Support and T-Tube?
- ClinicalTrials.gov ID
- NCT00853060
- Acronym / sponsor ID
- 04-415
- Conditions
- Respiration, Artificial, Energy Metabolism
- Keywords
- energy expenditure, mechanical ventilation, weaning, pressure support ventilation, T-tube
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 27 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During weaning from mechanical ventilation process, the energy expenditure in T tube is greater than pressure support ventilation.
Detailed description
The energy expenditure (EE) was measured during the two periods of 30-minutes, with the 10 first minutes being discarded for analysis purposes. The other variables were recorded and monitored during the 10th and the 30th minute, in both pressure support (PS) and t-Tube (TT) modes. Patients were randomized in terms of sequence selection: PS - TT or TT - PS. In the baseline period, patients were receiving mechanical ventilation (Servo 900C and Servo 300; Siemens-Elema, Solna, Sweden), with PS ranging from 10 to 15cmH2O. During the PS mode, patients received assisted pressure ventilation of 10 cmH2O, 5 cmH2O of final positive expiratory pressure, the sensitivity of -1cmH2O and FiO2 of 0.4. During TT mode, oxygen flow was delivered in order to keep the same FiO2 that was provided in PS (0.4) as controlled by monitor screen (Datex Ohmeda S/5 - Compact Airway Module, M-COVX model, Finland). In this mode, an extensor was employed, one end of which was connected to the oxygen-enriched and the other end was secured to a 3-output ("T") connector, which was attached to the patient's ventilatory prosthesis. During the rest period (30 minutes), patients returned to the mechanical ventilation parameters utilized in the baseline period.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with respiratory failure receiving MV fore more than 24 hours, who had been admitted to the Intensive Care Unit (ICU) of the Hospital de Clínicas de Porto Alegre and who met the criteria for weaning from MV according to the parameters previously defined were selected to participate in the study.
Key inclusion criteria (1 listed)
- Patients with acute respiratory failure receiving MV for over 24 hours, in the ICU of the Hospital de Clínicas de Porto Alegre
Key exclusion criteria (1 listed)
- Patients with chest drainage, hemodynamic instability (characterized by the use of vasoactive drugs), renal failure, mental status change, agitation, sudoresis, tachycardia, axillary temperature above 38°C and inspiratory oxygen fraction (FiO2) over 0.6.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2009.
Related trials for Respiration, Artificial
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
Not yet recruitingObservational study
Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
Recruiting
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Neonatal Resuscitation, Apnea Neonatal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Vieira, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiration, Artificial and Energy Metabolism, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2009.