Lung InfectionNCT03630510

Ventilator Hyperinflation With Increase of Inspiratory Time

A study testing Ventilator hyperinflation in people with Lung Infection and Mechanical Ventilation, run by Brazilian Institute of Higher Education of Censa at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Lung Infection, Mechanical Ventilation
What is being tested?: Ventilator hyperinflation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteBrazil
Study dates: 18 Mar 2017to 28 Mar 2018
Phase: Interventional
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients under mechanical ventilation for more than 48h
Mucus hypersecretion (defined as the need for suctioning < 2-h intervals)

Who cannot join

Severe bronchospasm,
Positive end expiratory pressure > 10cmH2O,
PaO2-FiO2 relationship < 150,
Mean arterial pressure < 60mmHg,
Pleural effusion or pneumothorax undrained,
Bronchopleural or tracheoesophageal fistula,
Decompensated congestive heart failure.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Luciano M Chicayban
Campos dos Goytacazes, Rio de Janeiro, 28015150

Other trials in Brazil

About this study

Official title: Ventilator Hyperinflation With Increase of Inspiratory Time on Respiratory Mechanics: A Randomized Crossover Trial

The investigators hypothesis is that the adjustment of the inspiratory time may optimize the distribution of ventilation and increase tidal volume, producing potential therapeutic effects on the displacement of secretions and respiratory mechanics. The objective of this study was To evaluate the effects of hyperinflation with the ventilator associated with increased inspiratory time on respiratory mechanics.

Read the detailed description

A randomized crossover clinical trial was conducted with 38 mechanically ventilated patients with pulmonary infection. The order of hyperinflation or control (without changes in parameters) was randomized. Hyperinflation was performed for 5 minutes in the controlled pressure ventilation mode, with progressive increases of 5cmH2O until reaching a maximum pressure of 35cmH2O, maintaining PEEP. After reaching 35cmH2O, the inspiratory time and respiratory rate were adjusted so that the inspiratory and expiratory flows reached the baseline, respectively. Static compliance (Cest, sr), total resistance (Rsr) and airway resistance (Rva), slow pressure drop (ΔP2) and peak expiratory flow (PEF) were assessed before (PRÉ), immediately after the maneuver (POSSimed) and after aspiration (POSPasp). Two-way ANOVA was used for repeated measurements with Tukey post-test, considering a significant p <0.05.

Conditions: Lung Infection, Mechanical Ventilation
Being tested: Ventilator hyperinflation
Keywords: Physical Therapy Modalities,, Respiration Artificial,, Respiratory Care Units,, Respiratory Mechanics,, Positive-Pressure Respiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ventilator hyperinflationOther
The ventilator hyperinflation maneuver with inspiratory time adjustment was performed in the pressure controlled ventilation mode (PCV). The inspiratory pressure was increased gradually every 5 cmH2O until reaching a maximum pressure of 35 cmH2O, according to the tolerance of the patient determined by the absence of cough. PEEP remained unchanged throughout the study. After reaching a maximum pressure of 35 cmH2O (PCV + PEEP level), the inspiratory time was gradually increased until the inspiratory flow reached the baseline. Concomitantly, the respiratory rate was decreased to allow the expiratory flow also to reach the baseline, to avoid self-PEEP. The maneuver was performed for 5 min, followed by tracheal aspiration.

Study groups in NCT03630510
Study group	Role	What they receive
mechanical ventilator hyperinflation	Experimental	The VHI maneuver with inspiratory time adjustment was performed in the pressure controlled ventilation mode (PCV). The inspiratory pressure was increased gradually every 5 cmH2O until reaching a maximum pressure of 35 cmH2O, according to the tolerance of the patient determined by the absence of cough. PEEP remained unchanged throughout the study. After reaching a maximum pressure of 35 cmH2O (PCV + PEEP level), the inspiratory time was gradually increased until the inspiratory flow reached the baseline. Concomitantly, the respiratory rate was decreased to allow the expiratory flow also to reach the baseline, to avoid self-PEEP. The maneuver was performed for 5 min, followed by tracheal aspiration. Receives: Other: Ventilator hyperinflation
Control	No intervention	To perform the control (CTRL), the patients were only positioned and aspirated, without alteration in ventilatory parameters.

What is being measured

The primary outcome is the main question the study is designed to answer.

Static compliance of respiratory system
Compliance was assessed through the occlusion maneuver at the end of inspiration, considering tidal volume, plateau pressure and PEEP. Three measurements were taken at each moment, the mean being used.
Measured: Baseline (before), immediately after VHI and five minutes after aspiration
Total Resistance of respiratory system
The total resistance of the respiratory system was evaluated through the occlusion maneuver at the end of the inspiration, considering the resistive pressure, measured by the difference between the maximum plateau pressure. Three measurements were taken at each moment, the mean being used.
Measured: Baseline (before), immediately after VHI and five minutes after aspiration
Airway Resistance
The airway resistance was assessed by means of the occlusion maneuver at the end of the inspiration, considering the rapid fall of the pressure immediately after the occlusion, measured by the difference between the maximum pressure and P1. Three measurements were taken at each moment, the mean being used.
Measured: Baseline (before), immediately after VHI and five minutes after aspiration
Peak expiratory flow
The peak expiratory flow was evaluated through passive expiration, being considered the greatest value of the flow in the expiratory phase.
Measured: Baseline (before), immediately after VHI and five minutes after aspiration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Mar 201728 Mar 2018

First posted15 Aug 2018
Study start18 Mar 2017
Primary completion12 Aug 2017
Study completion28 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lung InfectionStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: The VHI maneuver with inspiratory time adjustment was performed in the pressure controlled ventilation mode (PCV). The inspiratory pressure was increased gradually every 5 cmH2O until reaching a maximum pressure of 35 cmH2O, according to the tolerance of the patient determined by the absence of cough. PEEP remained unchanged throughout the study. The maneuver was performed for 5 min, followed by tracheal aspiration. To perform the control (CTRL), the patients were only positioned and aspirated, without alteration in ventilatory parameters.
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03630510
Sponsor's protocol ID: VHI + Tins
Status last verified: Aug 2018
First submitted: 2 Mar 2017
Last updated: 15 Aug 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chicayban LM. Acute effects of ventilator hyperinflation with increased inspiratory time on respiratory mechanics: randomized crossover clinical trial. Rev Bras Ter Intensiva. 2019 Oct 14;31(3):289-295. doi: 10.5935/0103-507X.20190052. eCollection 2019.
PubMed 31618346

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation

All Lung Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ventilator Hyperinflation With Increase of Inspiratory Time on Respiratory Mechanics: A Randomized Crossover Trial
ClinicalTrials.gov ID: NCT03630510
Acronym / sponsor ID: VHI + Tins
Conditions: Lung Infection, Mechanical Ventilation
Keywords: Physical Therapy Modalities,, Respiration Artificial,, Respiratory Care Units,, Respiratory Mechanics,, Positive-Pressure Respiration
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Brazilian Institute of Higher Education of CensaUniversity, hospital or other
Study start: 18 Mar 2017 (actual)
Primary completion: 12 Aug 2017 (actual)
Study completion: 28 Mar 2018 (actual)
First posted: 15 Aug 2018 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: The VHI maneuver with inspiratory time adjustment was performed in the pressure controlled ventilation mode (PCV). The inspiratory pressure was increased gradually every 5 cmH2O until reaching a maximum pressure of 35 cmH2O, according to the tolerance of the patient determined by the absence of cough. PEEP remained unchanged throughout the study. The maneuver was performed for 5 min, followed by tracheal aspiration. To perform the control (CTRL), the patients were only positioned and aspirated, without alteration in ventilatory parameters.

Arm	Type	Receives
mechanical ventilator hyperinflation	Experimental	Other: Ventilator hyperinflationThe VHI maneuver with inspiratory time adjustment was performed in the pressure controlled ventilation mode (PCV). The inspiratory pressure was increased gradually every 5 cmH2O until reaching a maximum pressure of 35 cmH2O, according to the tolerance of the patient determined by the absence of cough. PEEP remained unchanged throughout the study. After reaching a maximum pressure of 35 cmH2O (PCV + PEEP level), the inspiratory time was gradually increased until the inspiratory flow reached the baseline. Concomitantly, the respiratory rate was decreased to allow the expiratory flow also to reach the baseline, to avoid self-PEEP. The maneuver was performed for 5 min, followed by tracheal aspiration.
Control	No intervention	–To perform the control (CTRL), the patients were only positioned and aspirated, without alteration in ventilatory parameters.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients under mechanical ventilation for more than 48h
Mucus hypersecretion (defined as the need for suctioning < 2-h intervals)

Key exclusion criteria (7 listed)

Severe bronchospasm,
Positive end expiratory pressure > 10cmH2O,
PaO2-FiO2 relationship < 150,
Mean arterial pressure < 60mmHg,
Pleural effusion or pneumothorax undrained,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ventilator hyperinflationThe ventilator hyperinflation maneuver with inspiratory time adjustment was performed in the pressure controlled ventilation mode (PCV). The inspiratory pressure was increased gradually every 5 cmH2O until reaching a maximum pressure of 35 cmH2O, according to the tolerance of the patient determined by the absence of cough. PEEP remained unchanged throughout the study. After reaching a maximum pressure of 35 cmH2O (PCV + PEEP level), the inspiratory time was gradually increased until the inspiratory flow reached the baseline. Concomitantly, the respiratory rate was decreased to allow the expiratory flow also to reach the baseline, to avoid self-PEEP. The maneuver was performed for 5 min, followed by tracheal aspiration.	Other	mechanical ventilator hyperinflation

Primary outcome

Static compliance of respiratory system
Time frame: Baseline (before), immediately after VHI and five minutes after aspiration
Compliance was assessed through the occlusion maneuver at the end of inspiration, considering tidal volume, plateau pressure and PEEP. Three measurements were taken at each moment, the mean being used.
Total Resistance of respiratory system
Time frame: Baseline (before), immediately after VHI and five minutes after aspiration
The total resistance of the respiratory system was evaluated through the occlusion maneuver at the end of the inspiration, considering the resistive pressure, measured by the difference between the maximum plateau pressure. Three measurements were taken at each moment, the mean being used.
Airway Resistance
Time frame: Baseline (before), immediately after VHI and five minutes after aspiration
The airway resistance was assessed by means of the occlusion maneuver at the end of the inspiration, considering the rapid fall of the pressure immediately after the occlusion, measured by the difference between the maximum pressure and P1. Three measurements were taken at each moment, the mean being used.
Peak expiratory flow
Time frame: Baseline (before), immediately after VHI and five minutes after aspiration
The peak expiratory flow was evaluated through passive expiration, being considered the greatest value of the flow in the expiratory phase.

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 15 Aug 2018.
Derived from this study: PubMed 31618346Chicayban LM. Acute effects of ventilator hyperinflation with increased inspiratory time on respiratory mechanics: randomized crossover clinical trial. Rev Bras Ter Intensiva. 2019 Oct 14;31(3):289-295. doi: 10.5935/0103-507X.20190052. eCollection 2019.
Individual participant dataSharing planned: No

Related trials for Lung Infection

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation

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.

LUCIANO M CHICAYBAN principal investigator

Brazilian Institute of Higher Education of Censa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ventilator hyperinflation in people with Lung Infection and Mechanical Ventilation, run by Brazilian Institute of Higher Education of Censa 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 2 inclusion and 7 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 15 Aug 2018. 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.

What does the primary outcome measure?

Static compliance of respiratory system (time frame: Baseline (before), immediately after VHI and five minutes after aspiration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03630510, which also lists 1 linked publication.

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 15 Aug 2018.