Comparison of the Outcome of Using One-way Heimlich Valve in the Treatment of Primary Spontaneous Pneumothorax in Comparison with Implantation of Chest Tube and Connection to the Bottle, A Randomized Clinical Trial
Comparison of the Outcome of Using One-way Heimlich Valve in the Treatment of Primary Spontaneous Pneumothorax in Comparison with Implantation of Chest Tube and Connection to the Bottle
Design
A double-blinded, phase 3, randomized controlled clinical trial in Shahid Madani Hospital of Alborz University of Medical Sciences in 1402.
Patients will be randomly assigned to two groups with a one-to-one ratio (total sample size of 40) using the stratified block randomization method.
Settings and conduct
This study was conducted on patients with Primary Spontaneous Pneumothorax in Shahid Madani Hospital of Alborz University of Medical Sciences in Karaj in 1402. The patients will be divided into two groups of lung collapse below 50% and above 50%. Participants with the collapse below 50% will be randomly divided into two treatment groups with Chest Tube or One-way Heimlich Valve insertion, and participants with collapse above 50% will also be randomly divided into two treatment groups. After 48 hours, patients will be checked daily. Within 30 days from discharge, the patient will be examined weekly.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18 to 40 with Primary Spontaneous Pneumothorax with the lung collapse of more than 15%; No history of trauma; No complete lung collapse. Exclusion criteria: Developing complications and stop treatment; Treatment failure
Intervention groups
The first group will be treated by a Chest Tube number 16 and connection to the bottle and the second group by using a One-way Heimlich Valve.
Main outcome variables
Hospitalization duration; pain; Readmission; Complications; Severity of the shortness of breath; Treatment failure; The need for Ketorolac injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230208057359N1
Registration date:2023-02-13, 1401/11/24
Registration timing:prospective
Last update:2023-02-13, 1401/11/24
Update count:0
Registration date
2023-02-13, 1401/11/24
Registrant information
Name
Seyed Mohammad Naghibalghora Banadaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3726 4451
Email address
m.naghib@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Outcome of Using One-way Heimlich Valve in the Treatment of Primary Spontaneous Pneumothorax in Comparison with Implantation of Chest Tube and Connection to the Bottle, A Randomized Clinical Trial
Public title
Comparison of the Outcome of Using One-way Heimlich Valve in the Treatment of Primary Spontaneous Pneumothorax in Comparison with Implantation of Chest Tube and Connection to the Bottle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 40 years old with Primary Spontaneous Pneumothorax that is symptomatic and the lung collapse rate is more than 15% (the distance between the chest wall and the lung is more than 1 cm)
No history of trauma in the last month
No history of severe asthma or chronic obstructive pulmonary disease
Not suffering from psychosis
Do not require special medical services such as hospitalization in ICU
Do not have complete lung collapse
Not breastfeeding or pregnant
Exclusion criteria:
Patients who are eligible to enter the study but did not consent to enter the study
Patients who developed complications and the patient's treatment was discontinued
Patients in need of Video-assisted thoracoscopic surgery include having one lung, being a diver or a pilot, having a large Pulmonary Embolus
Treatment failure after 7 days
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants with the collapse below 50% were randomly assigned to two treatment groups with chest tube insertion or One-way Heimlich Valve insertion, and participants with collapse above 50% were randomly assigned to two treatment groups with chest tube insertion or One-way Heimlich Valve insertion (stratified randomization). For randomization, the block randomization method will be used, so that at first in the Excel software, blocks of four will be prepared as (AABB) (BBAA) (ABBA) (BAAB) (ABAB) (BABA). A indicates the group of One-way Heimlich Valve and B indicates the group of the chest tube connected to the Bottle. Then one of the blocks will be randomly selected and based on the sequence of letters in the selected block, the eligible people will be assigned to the treatment groups. This random process of selecting blocks and assigning people to treatment groups will continue until the desired sample size is reached. The preparation of the random allocation sequences of these two intervention groups and placing them in sealed envelopes and numbering with a 5-digit serial number is done by a third person who is not involved in the design of the study. All the envelopes have a 5-digit serial number, which are opened after recording background information, and the sample participants are divided into two intervention groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be double-blinded, so that the evaluator and the participants are not aware of the status of assigning participants to the study groups. It will be explained to the study subjects before the random assignment, how the work process is, and they may receive one of the two treatments randomly, and the treatment used for the individual is not known in advance. It will not be possible for the patients to distinguish these treatments from each other. Also, the outcome evaluator will be blinded about assigning participants to the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Ethics Committee Unit, Research and Technology Department of Alborz University of Medical Sciences, No 20, Safarian Alley, Golshahr Street, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2023-01-08, 1401/10/18
Ethics committee reference number
IR.ABZUMS.REC.1401.272
Health conditions studied
1
Description of health condition studied
Primary Spontaneous Pneumothorax
ICD-10 code
J93.11
ICD-10 code description
Primary spontaneous pneumothorax
Primary outcomes
1
Description
The hospitalization duration from the start of treatment until the time of removal of the chest tube
Timepoint
When the chest tube is removed, the hospitalization duration is calculated
Method of measurement
Days recorded in the patient's file
Secondary outcomes
1
Description
Pain Severity
Timepoint
Daily examination during hospitalization and weekly after discharge for up to 4 weeks
Method of measurement
Visual Analogue Scale score (0 to 10)
2
Description
Readmission
Timepoint
Weekly from the time of discharge up to 4 weeks
Method of measurement
Based on examinations, symptoms and paraclinical measures
3
Description
Treatment failure
Timepoint
7 days after the intervention
Method of measurement
No symptom improvement or incomplete opening of the lung after 7 days is considered as treatment failure
4
Description
Complications
Timepoint
Daily examination during hospitalization and weekly after discharge for up to 4 weeks
Method of measurement
Occurrence of complications including subcutaneous Emphysema, Hematoma and wound infection through examination and clinical symptoms
5
Description
Shortness of breath severity
Timepoint
Daily examination during hospitalization and weekly after discharge for up to 4 weeks
Method of measurement
Visual Analogue Scale score (0 to 10)
6
Description
Ketorolac injection
Timepoint
Daily examination during hospitalization
Method of measurement
The number of requests and the milligrams of the injected Ketorolac
Intervention groups
1
Description
For the participants in the first intervention group, chest tube number 28 will be inserted from the fourth or fifth intercostal space in the area of the anterior to mid-axillary line and it will be connected to the bottle. Patients will receive supportive treatments such as incentive spirometry and respiratory physiotherapy, and they will be prescribed oral acetaminophen 10 mg per kilogram of weight. In case of shortness of breath, they will receive nasal oxygen.
Category
Treatment - Surgery
2
Description
For participants in the second intervention group, tube number 28 will be inserted from the fourth or fifth intercostal space in the area of the anterior to mid-axillary line and it will be and connected to the one-way Heimlich valve. Patients will receive supportive treatments such as incentive spirometry and respiratory physiotherapy, and they will be prescribed oral acetaminophen 10 mg per kilogram of weight. In case of shortness of breath, they will receive nasal oxygen.