IRCT | The effect of respiratory muscle exercises on pulmonary functional indices and successful extubation in patients hospitalized in the intensive care unit."

Protocol summary

Study aim: Determining the effect of respiratory muscle training on lung function indicators and success of extubation in patients hospitalized in the intensive care unit
Design: The present study is a controlled clinical trial. Patients are randomly assigned to intervention and control groups. The sample size in each group will be calculated as a pilot. Samples with entry criteria are selected in the available method, and then permutation blocks with size 4 and 2 will be produced by a statistician with the help of Stata software version 17. To hide the allocation of each block, it will be placed in an envelope. After completing each sampling with the envelope, the envelope is discarded and the next envelope will be opened.
Settings and conduct: Special care departments of Imam Reza Hospital in Mashhad
Participants/Inclusion and exclusion criteria: Entry criteria: more than 48 hours under mechanical ventilation, GCS ≥ 13, PI max ≤ -20 cmH2O, PaO2 > 60, PaO2/FiO2 ≥ 200, SPO2 > 90, TV > 5 ml/kg, RR < 35, RSBI < 135 lit/min, no fever and stable hemodynamic status. Exclusion criteria: inability to perform breathing exercises, unstable hemodynamic status of the patient, presence of barotrauma, need to use sedative or muscle relaxant during intervention, history of neuromuscular disease
Intervention groups: In both groups, routine exercises including chest physiotherapy will be performed by a physiotherapist once a day. In the intervention group, in addition to routine exercises, respiratory muscle strengthening exercises using the Threshold IMT/PEP device, twice a day for one week, include: tail muscle exercises In 5 sets of 10 breaths with an intensity of 40% of PImax and exhalation exercises with PEP: 7 cm H2O will be done for half an hour.
Main outcome variables: RSBI؛ MIP؛ MEP؛ pulmonary compliance; Diaphragm thickness; Extubation success

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20230214057418N1

Registration date: 2023-04-14, 1402/01/25

Registration timing: prospective

Last update: 2023-04-14, 1402/01/25

Update count: 0
Registration date: 2023-04-14, 1402/01/25

Registrant information: Name

Mohammad Kazemi

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 51 3211 9640

Email address

kazemim4001@mums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-05-10, 1402/02/20
Expected recruitment end date: 2023-10-22, 1402/07/30
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The effect of respiratory muscle exercises on pulmonary functional indices and successful extubation in patients hospitalized in the intensive care unit."

Public title: The effect of breathing training on lung function and extubation
Purpose: Supportive
Inclusion/Exclusion criteria: Inclusion criteria:

be under mechanical ventilation for more than 48 hours GCS ≥ 13 PI max ≤ -20 cmH2O PaO2>60 PaO2/FiO2 ≥ 200 SPO2>90 TV > 5 ml/kg RR<35 RSBI < 105 lit/min no fever stable in hemodynamic status age between 18-80 years old

Exclusion criteria:

A history of neuromuscular disease that may affect respiratory muscle function.
Age: From 18 years old to 80 years old
Gender: Both

Phase

N/A

Groups that have been masked

Outcome assessor
Data analyser

Sample size

Target sample size: 60

Randomization (investigator's opinion)

Randomized

Randomization description

Samples meeting the inclusion criteria will be selected, and then permuted blocks of size 4 and 2 will be generated using Stata software version 17 by a statistician. To conceal the allocation of each block, they will be placed in a packet.

Blinding (investigator's opinion)

Single blinded

Blinding description

The method of closed envelopes is used to allocate patients to groups. In this way, the generated random sequences are kept in closed envelopes. When a patient with inclusion criteria is found, the envelope is opened to identify his group. The outcome assessor and the statistics professor will also be unaware of this allocation.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Mashhad University of Medical Sciences

Street address

Daneshgah Ave, Ghoeishi Building

City

Mashhad

Province

Razavi Khorasan

Postal code

9137913199
Approval date: 2023-03-14, 1401/12/23
Ethics committee reference number: IR.MUMS.NURSE.REC.1401.123

Health conditions studied

1

Description of health condition studied: Weakness of respiratory muscles in patients under mechanical ventilation.
ICD-10 code: Z99.11
ICD-10 code description: Dependence on respirator [ventilator] status

Primary outcomes

1

Description: pulmonary functional indices
Timepoint: Every day before and after the intervention
Method of measurement: Ventilator

2

Description: successful extubation
Timepoint: 48 hours after extubation
Method of measurement: Clinical symptoms

Secondary outcomes

empty

Intervention groups

1

Description: Control group: Control group: Routine exercises include chest physiotherapy (Vibration & Percussion, etc.) in the form of creating passive movement in the organs, compression and percussion in the chest, compressive stretching and vibration on the chest and changing the position, which is done by the physiotherapist. It is performed once a day for an average of 15 minutes, the intensity of which will vary based on the patient's cooperation and vital signs.
Category: Treatment - Devices

2

Description: Intervention group: Intervention group: in the test group, in addition to physical therapy routine exercises, inspiratory and expiratory muscle strengthening exercises will be added by the Threshold IMT/PEP device that is connected to the end of the tracheal tube. Respiratory muscle exercises twice a day for one week include: inspiratory muscle exercises under the supervision of the researcher in 5 sets of 10 breaths with an intensity of 40% of PImax and expiratory exercises with PEP: 7 cm H2O for half an hour.
Category: Treatment - Devices

Recruitment centers

1

Recruitment center: Name of recruitment center

Imam Reza Hospital

Full name of responsible person

Razieh Froutan

Street address

Ibn Sina Street, Imam Reza Hospital Square, Imam Reza Educational Research and Treatment Center

City

Mashhad

Province

Razavi Khorasan

Postal code

٩١٣٧٩١٣٣١۶

Phone

+98 51 3854 3031

Email

froutanr@mums.ac.ir

1

Sponsor: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Majid Ghayour Mobarhan

Street address

University Street, Mashhad

City

Mashhad

Province

Razavi Khorasan

Postal code

9138813944

Phone

+98 51 3841 2081

Email

p.relations@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Mashhad University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Mohammad Kazemi

Position

Masters student

Latest degree

Bachelor

Other areas of specialty/work

Nursery

Street address

Number 41, Shahid Rajabi 6 , North Tabarsi 10

City

Mashhad

Province

Razavi Khorasan

Postal code

9149843112

Phone

+98 51 3211 9640

Fax

Email

KazemiM4001@mums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Razieh Froutan

Position

Associate Professor of Nursing

Latest degree

Ph.D.

Other areas of specialty/work

Nursery

Street address

University Street, Mashhad

City

Mashhad

Province

Razavi Khorasan

Postal code

9137913199

Phone

+98 51 3859 1511

Email

froutanr@mums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Mohammad Kazemi

Position

Masters student

Latest degree

Bachelor

Other areas of specialty/work

Nursery

Street address

Number 41, Shahid Rajabi 6 , North Tabarsi 10

City

Mashhad

Province

Razavi Khorasan

Postal code

9149843112

Phone

+98 51 3211 9640

Fax

Email

KazemiM4001@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD: There is no further information
Study Protocol: No - There is not a plan to make this available
Statistical Analysis Plan: No - There is not a plan to make this available
Informed Consent Form: No - There is not a plan to make this available
Clinical Study Report: No - There is not a plan to make this available
Analytic Code: No - There is not a plan to make this available
Data Dictionary: No - There is not a plan to make this available

The effect of respiratory muscle exercises on pulmonary functional indices and successful extubation in patients hospitalized in the intensive care unit."