NCT03758573

Brief Summary

The long stay in mechanical ventilation can induce several complications, among them respiratory muscle weakness, this has been related to the duration of mechanical ventilation, delay and failure to wean, resulting in longer hospitalization, which reflects in greater care increase in hospital costs. Therefore, of this research will be to compare the effectiveness of early inspiratory muscle training (IMT) versus non-IMT in patients undergoing mechanical ventilation to improve the outcome of mechanical ventilation weaning time.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

5 years

First QC Date

November 21, 2018

Last Update Submit

May 9, 2023

Conditions

Respiratory Insufficiency

Keywords

Breathing ExercisesRespiratory MusclesRespiration ArtificialWeaning

Outcome Measures

Primary Outcomes (1)

  • Weaning mechanical ventilation

    time of mechanical ventilation

    through study completion, an average of 15 days

Secondary Outcomes (3)

  • length of stay in the ICU

    through study completion, an average of 15 days

  • extubation success

    through study completion, an average of 2 days

  • death

    yes or not death, through study completion, an average of 15 days

Study Arms (2)

Inspiratory Muscle Training (IMT)

EXPERIMENTAL

IMT by means of the Powerbreath equipment (Classic, London, UK), according to the following parameters: initial loading of 40% of MIP, 3 sets of 10 repetitions with interval of 1 minute between each sets, 7 days a week, 2 times a day , with the patients in the bed with the angulation of 45 °. The IMT load settings will be adjusted according to the values evaluated weekly. If there is need for addition of supplemental oxygen will be performed to perform the IMT.

Other: Inspiratory Muscle Training (IMT)

Intensive Physiotherapy (IPT)

ACTIVE COMPARATOR

IPT will be to individualized and supervised intervention program consisting of any of the following procedures: passive, assisted, active or resisted mobilization, sedation and orthostasis depending on the functional level of the patient, as well as bronchial hygiene therapy and pulmonary expansion therapy.

Other: Intensive Physiotherapy (IPT)

Interventions

Inspiratory Muscle Training (IMT)OTHER

Inspiratory Muscle Training (IMT)

Inspiratory Muscle Training (IMT)
Intensive Physiotherapy (IPT)OTHER

Intensive Physiotherapy (IPT)

Intensive Physiotherapy (IPT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • invasive mechanical ventilation
  • patients hemodynamically stable
  • without use of vasoactive drugs

You may not qualify if:

  • spindle trauma
  • neuromuscular diseases
  • end-stage disease
  • pneumothorax
  • rib fracture
  • diaphragmatic injury
  • postoperative pulmonary surgeries
  • abdominal disease
  • morbidities that have repercussions on diaphragmatic contraction
  • mechanical ventilation with FiO2 \> 60% and PEEP \> 10 cm H2O

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Education College

Petrolina, Pernambuco, 56304917, Brazil

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Rodrigo GS Carvalho, PhD

    Physical Education College / UNIVASF

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo GS Carvalho, PhD

CONTACT

+5587999832015rodrigocarvalhofisio@gmail.com

Rodrigo GS Carvalho, PhD

CONTACT

+558721016856rodrigo.carvalho@univasf.edu.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Compare the effectiveness of early inspiratory muscle training (IMT) versus non-IMT in patients undergoing mechanical ventilation to improve the outcome of mechanical ventilation weaning time.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 29, 2018

Study Start

January 15, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Registration ClinicalTrials; Study Protocol; Paper results.

Locations

BR(1)