Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201909644273809 Date of Approval: 30/09/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of a Threshold Trainer on Inspiratory Muscle Strength in Mechanically Ventilated Patients: A Randomized Controlled Trial
Official scientific title Effects of a Threshold Trainer on Inspiratory Muscle Strength in Mechanically Ventilated Patients: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Mechanical ventilation is known to adversely affect the diaphragmatic structure and function thus resulting in respiratory muscle weakness. The study aims to investigate the effect of threshold trainer on inspiratory muscle strength of mechanically ventilated patients through the following objectives: I. To determine the effect of Threshold trainer on maximal inspirational pressure variations. II. To determine the effect of a Threshold trainer on the patient’s oxygenation. III. To determine the effect of Threshold trainer on the ICU length of stay. IV. To determine the effect of Threshold trainer on the respiratory (respiratory rate) and cardiac (Heart Rate) systems.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/01/2020
Actual trial start date
Anticipated date of last follow up 30/06/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Threshold inspiratory muscle training The patient will be encouraged to take 6 breaths through the Threshold trainer for five sets. This will be done twice a day Until the patient is successfully extubated. Threshold inspiratory muscle training : I. MIP measurements will be taken before the commencement of the treatment. Participants will be pre-oxygenated for 120 seconds, thereafter they will encouraged to take a deep breath. This will be done three times and the best of the three measure will be recorded. II. The patient will be placed into semi-fowler’s position 450 for the commencement of Threshold inspiratory muscle training. III. Threshold inspirational muscle training will be done 30 minutes before manual chest physiotherapy so as to prevent fatigue. (Dixit et al., 2014) IV. Threshold device set at 50% of the patient’s baseline MIP thereafter increased by 10% daily (Ibrahiem et al., 2014). V. The Threshold inspiratory muscle trainer device will be connected between the endotracheal tube and the circuit by an oxygen adopter and will give the set resistance as the patient takes an independent breath. VI. The patient will be encouraged to take six deep breaths. This will be done five times with the patient getting one minute of rest in between breaths. (Ibrahiem et al., 2014). The total treatment will consist of thirty breaths. VII. If the patient is unable to cope, treatment will be stopped for that session (am/pm) and the number of breaths recorded. Treatment will commence again with the same setting at the next session. VIII. Threshold training will be stopped if adverse effects (such as drop in blood pressure, drop in saturation, tachypnea etc.) are noted. 40
Control Group Standard Manual Chest Physiotherapy treatment Twice a day for 30 minutes Until successful extubation Standard manual chest physiotherapy treatment • Active cycle breathing techniques • Vibrations • Percussions • Postural drainage • Suctioning 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
I. Participants should be intubated for at least 48 hours on PSIMV, CPAP, BiPAP or T-piece. II. Participants should be on FiO2 of 50% and less, PEEP of 8cmH2O or less, SpO2 of 90% and above. III. Participants should be haemodynamically stable (with BP no less than 100/60 mmHg or more 150/90 mmHg, HR of no more 120 b/minute, temperature no more than 37.50C). IV. Conscious and able to respond to verbal commands with a GCS of 7/10 and above. V. Participants should be able to maintain a semi-fowler position for at least 15 minutes. I. Participants will be excluded if they are haemodynamically unstable. II. Participants will be excluded if they have conditions that compromise inspiratory muscle training (e.g flail chest, neuropathies, myopathies, distended abdomen, open abdomen). III. Participants on sedatives or paralyzing medication at the time of assessment (propofol , dormicum, high levels of morphine etc) IV. Participants who cannot offer co-operation. V. Pain with a VAS of more than 8. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/11/2018 University of Pretoria
Ethics Committee Address
Street address City Postal code Country
31 Bophelo Road Gezina Pretoria 0007 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Maximal inspiratory pressure (MIP) Maximal inspiration pressure is an effective method for evaluating inspiratory muscle strength, thus giving the effect of It is used as a diagnostic tool , as a predictive mechanical index (Black et al., 1969) 2. Rapid shallow breathing index (RSBI) The rapid shallow breathing index is the known ration of respiratory rate and spontaneous tidal volume. Before and after intervention
Secondary Outcome 1.Rate of re-intubation For the purpose of this study, re-intubation is defined as any intubation after 48 hours following primary extubation, (Brueckmann, Villa-Uribe, Bateman, Grosse-Sundrup, Hess, Schlett, et al., 2013). The number of participants who will be re-intubated after successful extubation will be recorded and the rate of re-intubation will be calculated as a percentage of the total number of participants in either a control or experimental group. 2. Arterial Blood Gas Arterial blood gases will be recorded as per ICU protocol, changes in levels of arterial blood oxygen, carbon dioxide, saturation levels, and pH will be interpreted to show improvement in oxygenation of all participants, with interest in increased levels of CO2. After intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Netcare Ferncres hospital Moumo Street Tlhabane 0309 South Africa
Life Peglerae Private hospital Beyers Naude Rustenburg 0300 South Africa
Medicare Private Hospital Beyers Naude Rustenburg 0300 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Kelebogile Montsho 11 Sysie Avenue Safartuine Rustenburg 0300 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kelebogile Montsho 11 Sysie avenue Safarituine Rustenburg 0300 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Nomeko Mshunqane University of Pretoria Pretoria 0007 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kelebogile Montsho kelerox@gmail.com 0825631091 11 Sysie Avenue Safarituine
City Postal code Country Position/Affiliation
Rustenburg 0300 South Africa Physiotherapist
Role Name Email Phone Street address
Scientific Enquiries Nombeko Mshunqane nombeko.mshunqane@up.ac.za 0123563235 HW Snyman Building Gezina
City Postal code Country Position/Affiliation
Pretoria 0007 South Africa Principal Supervisor
Role Name Email Phone Street address
Public Enquiries Silmara Hanekom silmara.hanekom@gmail.com 0123563084 snyman buidling gezina
City Postal code Country Position/Affiliation
pretoria South Africa Clinical trial supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the participant data collected during the trial will be available for sharing. Informed Consent Form,Statistical Analysis Plan,Study Protocol 3 Months after the commencement of the trial, until5 years after completion of the trial. Data will be made available for access through the University of Pretoria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information