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.: PACTR202002728476768 Date of Approval: 26/02/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Initial management of well tolerated but voluminous primary pneumothorax : intercostal chest tube versus needle aspiration.
Official scientific title Study PRotocol for the INitial management of well toleraTED but voluminous primary pneumothorax
Brief summary describing the background and objectives of the trial there is evidence that conservative management of small pneumothoraces may be effective and safe. But the initial approach of a primary pneumothorax with large volume is still to debate. the objectives were to compare the effectiveness and the safety of a chest tube or a needle aspiration in large primary pneumothorax, then to assess the recurrence risk in one year using one technique or the other.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PRINTED
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/02/2020
Actual trial start date 01/02/2020
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date 31/12/2021
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status 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 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 needle aspiration group needle aspiration lasts for two to five minutes. inpatient surveillance lasts for five days. the needle aspiration is done according to asepsis rules. we use a 16 gauges needle connected by a three-way tap and an exit tube under water to an aspiration source. needle aspiration lasts for two to five minutes. the intervention ends when there is no more bubbling underwater. then, a chest X-ray is performed. if it shows a failure, a chest tube is inserted. if not, daily clinical examination, daily chest X-ray and in bed resting lasts for five days. Success is defined by an interpleural distance measured in the apex, inferior than 1 cm. It can be noted immediately after the aspiration or after five days of resting. Failure is defined by an interpleural distance superior than 3 cm. 50
Control Group chest tube after chest tube insertion, soft aspiration (minus 20 cm H2O) is maintained for five days starting from the first chest X Ray showing a total regression of the pneumothorax. the intervention is performed according to asepsis rules. we insert a 24 French chest tube in the second intercostal space. after chest tube insertion, soft aspiration (minus 20 cm H2O) is maintained for five days starting from the first chest X Ray showing a total regression of the pneumothorax. daily clinical examination, daily chest X-ray and in bed resting lasts for five days. in the case of failure, a thoracic surgeon is informed and a surgical pleurodesis is proposed. Failure is defined by an active bubbling after 48 hours, or a large pneumothorax still noted after five days of aspiration. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age above eighteen years old normal neurological state written informed consent First episode of large pneumothorax defined by a volume surpassing 41% of thoracic volume, which correspond to an interpleural distance over 8 cm according to Collins Formula. No radiological sign of an underlying pulmonary disease No signs of a non tolerated pneumothorax Past medical history of pneumothorax Radiological sign of secondary pneumothorax Hydropneumothorax Bilateral pneumothorax clinical signs of a non tolerated pneumothorax : oxymetry< 90% , schock index PAS/FC < 1 HIV infection impossibility to consent due to mental impairement incarceration Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 Year(s) Male
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 27/11/2019 Ethics commitee of Abderrahmen Mami Hospital
Ethics Committee Address
Street address City Postal code Country
2 rue de l hopital ARIANA 2080 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Success rate 5 days after procedure of pneumothorax evacuation - Success for manual aspiration was defined as complete or nearly complete and persistent lung expansion. Tolerated interpleural distance in the apex is less than 1 cm - Success for chest tube drainage was defined as complete lung expansion, absence of air leakage , and soft aspiration removal within 5 days after tube placement - day of discharge from hospital
Secondary Outcome Immediate success rate after procedure of pneumothorax evacuation - Immediate success for manual aspiration was defined as complete or nearly complete and persistent lung expansion immediately following manual aspiration. - Immediate success for chest tube drainage was defined as complete lung expansion, absence of air leakage in less than 48 hours after tube placement - after evacuation procedure
Secondary Outcome need for pleurodesis in case of persistence of pneumothorax day of discharge from hospital
Primary Outcome recurrence rate over one year of follow up after one year of follow up
Secondary Outcome Hospitalization duration day of discharge from hospital
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
abderrahmen mami hospital rue de l hopital ARIANA 2080 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Belloumi nidhal service de pneumologie Pavillon 4 . hopital Abderrahmen Mami . rue de l hopital Ariana 2080 Tunisia
abderrahmen mami hospital rue de l hopital Ariana 2080 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor nidhal belloumi service de pneumologie Pavillon 4 Hopital A Mami Ariana 2080 Tunisia Individual
Secondary Sponsor imen bachouch service de pneumologie Pavillon 4 hopital A Mami Ariana 2080 Tunisia Individual
Secondary Sponsor chermiti ben abdallah fatma service de pneumologie Pavillon 4 Hopital A Mami Ariana 2080 Tunisia Individual
Secondary Sponsor soraya fenniche service de Pneumologie Pavillon 4 Hopital A Mami Ariana 2080 Tunisia Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator nidhal belloumi nidhalbelloumi@gmail.com +21620456190 rue de l hopital. Service de pneumologie Pavillon 4 Hopital A Mami
City Postal code Country Position/Affiliation
Ariana 2080 Tunisia Service de pneumologie Pavillon 4 Hopital A Mami
Role Name Email Phone Street address
Scientific Enquiries fatma chermiti ben abdallah cherabdallah@yahoo.fr +21658084887 rue de l hopital. Service de pneumologie Pavillon 4 Hopital A Mami
City Postal code Country Position/Affiliation
Ariana 2080 Tunisia Service de pneumologie Pavillon 4 Hopital A Mami
Role Name Email Phone Street address
Public Enquiries soraya fenniche soraya.fenniche@yahoo.fr +21698586490 rue de l hopital. Service de pneumologie Pavillon 4 Hopital A Mami
City Postal code Country Position/Affiliation
ariana 2080 Tunisia Service de pneumologie Pavillon 4 Hopital A Mami
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1. The Excel + SPSS data used to support the findings of this study are available from the corresponding author upon request. Corresponding Author : Nidhal Belloumi E Mail : nidhalbelloumi@gmail.com Clinical Study Report,Informed Consent Form,Study Protocol findings of this study will be available in January 2022 Requests of data will be answered by mail after discussion between the principal investigator and collaborators. Nevertheless, our laboratory encourages open access, stands in favor of removing barriers for those who seek access to data and sees no limitations on how data can be used in order to promote transparency, reproducibility, and more rapid advancement of new knowledge and discovery.
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