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.: PACTR202201706227234 Date of Approval: 14/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of one nostril inhalation, added to standard physiotherapy management, on hospital length of stay and pulmonary complications in patients with thoracic trauma: a randomised trial.
Official scientific title The effect of one nostril inhalation, added to standard physiotherapy management, on hospital length of stay and pulmonary complications in patients with thoracic trauma: a randomised trial.
Brief summary describing the background and objectives of the trial Trauma is the second most common cause of death in South Africa and has been found to be the leading cause of death in young adults. Chest injuries are unique due to their potential for rapid deterioration, the need for aggressive resuscitation and an associated high mortality rate. Pneumonia is the most common complication that develops post thoracic injury. Physiotherapists play an important part in the multidisciplinary team management of patients with thoracic trauma. The aims of physiotherapy in these patients are to improve clinical outcomes such as decreasing the occurrence of complications, reducing mortality, improving lung volumes and oxygenation, optimizing mobilization and decreasing hospital length of stay. One nostril inhalation (ONI) is a new type of inexpensive resistance breathing, for which no equipment is needed. It has been introduced as a modality to decrease inspiratory flow and rate, and regain breathing control for patients who are experiencing pain. There is a dearth of research on the effect of ONI on pain experienced by patients with thoracic trauma. The aim of this study is to describe the effect of ONI, added to standard physiotherapy management, on the incidence of respiratory complications and hospital length of stay of patients with thoracic trauma. Preliminary findings will be provided on the effectiveness of ONI on clinical outcomes of patients with thoracic trauma. The standard physiotherapy care that such patients receive at the study site will also be described. The findings of this preliminary clinical trial will form the foundation on which future clinical research in this patient population can be modelled. This trial forms part of phase 2 of a larger project titled 'Physiotherapy management of patients who sustained thoracic trauma: a multi-center study' for which ethics clearance was obtained in 2020.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/02/2022
Actual trial start date
Anticipated date of last follow up 30/11/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 150
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group One Nostril Inhalation Every second waking hour of the day. (Every 2 hours) (10 breaths) 5 min The ONI technique will be taught as slow and deep inspirations with the mouth and one nostril closed by hand. The participant will be informed to perform sets of 10 deep breaths every second waking hour of the day and, in addition, when experiencing pain. 75
Control Group Standard Physiotherapy treatment once a day 20 min Deep breathing exercises Active coughing PEP Active trunk and upper limb exercises Mobilisation 75 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult (18 years and older) male and female patients Diagnosed with traumatic injury to the thorax and breathing spontaneously (without assistance from a mechanical ventilator) Standardised 5 questions (S5Q) score of 4-5/5 (indicates close to full or full cooperation) Patients with accompanying acute or previously diagnosed spinal cord injury or traumatic brain injury Those with accompanying complex fractures of the pelvis or lower limbs that restrict active mobilization Those with amputation of the lower limb/s Those with accompanying extensive abdominal trauma (repeat laparotomy procedures) that requires prolonged immobilization for healing purposes 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 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 27/06/2020 Human Research Ethics Committe Medical
Ethics Committee Address
Street address City Postal code Country
Research Office, Faculty of Health Sciences, Phillip Tobias Building, Offices 301-304, 3rd Floor, Cnr York Road and 29 Princess of Wales Terrace, Parktown, 2193. Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome hospital length of stay and incidence and type of pulmonary complications developed At discharge from hospital
Secondary Outcome Functional Status Score for ICU (FSS-ICU) Day 1,3,5,7,10,15,20,25,30
Secondary Outcome 10-meter walk test Day 1,3,5,7,10,15,20,25,30
Secondary Outcome Timed Up and Go (TUG) Test Day 1,3,5,7,10,15,20,25,30
Secondary Outcome One minute sit to stand test Day 1,3,5,7,10,15,20,25,30
Secondary Outcome Adverse events Day 1,3,5,7,10,15,20,25,30
Secondary Outcome Level of pain Day 1,3,5,7,10,15,20,25,30
Secondary Outcome ICU admission At discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chris Hani Baragwanath Academic Hospital 26 Chris Hani Rd Johannesburg 1864 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of the Witwatersrand 27 St Andrews Road, Parktown Johannesburg 2193 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor None N/A Johannesburg South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sameer Tootla sameertootla@gmail.com +2732878813 40 Lark Street Extension 1 Lenasia
City Postal code Country Position/Affiliation
Johannesburg 1827 South Africa Physiotherapist
Role Name Email Phone Street address
Public Enquiries Sameer Tootla sameertootla@gmail.com 0832878813 40 Lark Street Extension 1 Lenasia
City Postal code Country Position/Affiliation
Johannesburg South Africa Physiotherapist
Role Name Email Phone Street address
Scientific Enquiries Sameer Tootla sameertootla@gmail.com 0832878813 40 Lark Street Extension 1 Lenasia
City Postal code Country Position/Affiliation
Johannesburg South Africa Physiotherapist
Role Name Email Phone Street address
Principal Investigator Heleen Van Aswegen helena.vanaswegen@wits.ac.za +27117173702 Wits Education Campus, 27 St Andrews Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Personal Professor at University of the Witwatersrand and study supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual patient data will be collected and de-identified data will be used to report the results of this trial through publication in a peer-reviewed rehabilitation journal. Individual patient data sharing will not be available. A summary of results from this trial will be reported within the trial registration record within 12 months of the study completion date. Study Protocol Not applicable Not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not available 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