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.: PACTR201802003024149 Date of Approval: 27/01/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Laser Puncture on Arterial Blood Gased for Mechanically Ventilated Patients
Official scientific title Effect of Laser Puncture on Arterial Blood Gased for Mechanically Ventilated Patients
Brief summary describing the background and objectives of the trial PURPOSE: The purpose of the study is to determine the effect of laser puncture on arterial blood gases for mechanically ventilated patient. BACKGROUND: ¿ Mechanical ventilation is indicated in acute reversible respiratory failure. However, patients receiving mechanical ventilation may have an increased risk of sputum retention, atelectasis, and pneumonia, making ventilation weaning more difficult and resulting in excess morbidity and mortality. The cost of maintaining patients on prolonged ventilation in the ICUs of acute care hospitals is high. Thus, every effort should be made to determine which patients can be rapidly extubated so as to keep the weaning period to a minimum .Laser therapy has biostimulative and tissue regenerative properties as well as antimicrobial, anti-inflammatory and analgesic effects. Studies on its effects in respiratory disease have shown improvement in both gas exchange and pulmonary function, as well as enhanced immunity and other health benefits. HYPOTHESES: It will be hypothesized that there is no effect of laser puncture on arterial blood gases for mechanically ventilated patient. RESEARCH QUESTION: Does, laser puncture have an effect on arterial blood gases for mechanically ventilated patient?
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied mechanically ventilated patient due to respiratory failure,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2017
Actual trial start date 01/01/2018
Anticipated date of last follow up 07/01/2018
Actual Last follow-up date 07/01/2018
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 30
Recruitment status Closed to recruitment,follow-up continuing
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 randomisation using by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Twenty subjects will receive both Laser puncture and conventional chest physiotherapy output of 5¿20 mW, wavelength of 905 nm and frequency of 5000 Hz study period for 7 days Twenty subjects will receive Low level laser therapy using (Phyaction CL) with output of 5¿20 mW, wavelength of 905 nm and frequency of 5000 Hz. ( throughout the body along 12 main pathways known as meridians) for 7 days . 20
Control Group Twenty subjects will receive conventional chest physiotherapy only twice daily for 7 days study period for 7 days Conventional Chest physiotherapy in the form of positioning , percussion, vibration and suction is applied for all patients in both groups. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age of the patients from 40 to 60 years old. 2. All patients are respiratory failure on mechanical ventilator. 3. Subjects will be assigned randomly on a 1 : 1 : basis to one of two treatment groups A&B, equally in number. ¿ Un drained pneumothorax. ¿ Skin cancer. ¿ Tattoos at site of application of laser acupuncture. ¿ Acute cardiac vascular dysfunction (myocardial ischemia ). ¿ Other systemic disease (eg. systemic lupus erythematosus ,or AIDS ). ¿ Age over 60 or less than 40 years old. 40 Year(s) 60 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 03/04/2016 Research Ethical Committee ,Faculty of physical therapy , Cairo University
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzaiat St., Ben Elsarayat-ElDokki- Giza-Egypt Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome arterial blood gases before and after the treatment ¿ PaO2 (partial arterial oxygen pressure) , PaCO2 (partial arterial carbon dioxide pressure) ¿ O2 %( oxygen saturation) ¿ PaO2 / FiO2 (% of O2 pressure and fraction inspired O2) At the beginning and after finishing the study
Secondary Outcome Heart rate, respiratory rate, mean arterial pressure,tidal volume, minute ventilation, rapid shallow breathing index the ratio of the frequency of breathing divided by the tidal volume and dynamic lung compliance scores At the beginning and After finishing the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
critical care unit in Cairo University hospitals. 27 Nafezet Sheem El Shafaey St.¿ KASR EL AINY Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Zeinab Sami Ali Ahmed El ensha El hadetha El Mehalla El-Kobra - GHarbia- Egypt 31829 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Cairo University Street- Giza Giza - EGYPT 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Prof.,Dr. Hany Farid Eid Morsy Tal ELfahmyeen - EL Saf Giza - EGYPT 12897 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amany Mohamed amany.raafat@yahoo.com 002-01001654457 31 Alkafoor
City Postal code Country Position/Affiliation
Alzaytoon, Cairo ,Egypt 11734 Egypt Assistant, Professor (consultant ) of Physical Therapy Critical Care Department
Role Name Email Phone Street address
Public Enquiries Azza Ismail dr.azzafekry@yahoo.com 002-01009983675 15 Fouad Bedwany
City Postal code Country Position/Affiliation
Nassr , Cairo 11765 Egypt Professor of Physical Therapy for Cardiovascular ,Respiratory Disorder and Geriatrics
Role Name Email Phone Street address
Scientific Enquiries Hany Morsy Hanyelsisi24@yahoo.com 002-01146020419 Tal Elfahmyeen -Elsaf
City Postal code Country Position/Affiliation
Giza -EGYPT 12897 Egypt Assistant, Professor of Physical Therapy for Cardiovascular Respiratory Disorders and Geriatrics
REPORTING
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