Pneumothorax Spontaneous Primary, Pneumothorax, Recurrent, Pneumothorax Spontaneous Tension, Pneumothorax, Spontaneous
Conditions
Brief summary
Spontaneous pneumothorax is a common condition which is defined as air presence inside of pleural space. Despite, several studies that have been carried on management patients suffering spontaneous pneumothorax, the first step approach on patients is still the topic of debate. Since chest tube drainage and needle aspiration are widely used first step techniques in spontaneous pneumothorax, current study compares the efficacy of abovementioned techniques, as well as long-term outcomes. In current multi-center single-blinded RCT, all patients admitted with spontaneous pneumothorax will be enrolled study and written consent form provided by patients, simultaneously. Patients randomly assigned to study groups including (A) chest tube drainage and (B) needle aspiration. Subsequently, all patients will undergo one-year follow-up and will be evaluated in terms of treatment success rate and pneumothorax recurrence. Hypothesis of present trial are as follows: a) repetitive needle aspiration may lead to higher treatment success rate in patients with primary spontaneous pneumothorax, in comparison to chest tube drainage, b) needle aspiration may result in reduction of hospital admission duration in patients with primary spontaneous pneumothorax compared to chest tube drainage, c) the rate of spontaneous pneumothorax recurrence during one-year follow up might be lower in patients who undergo needle aspiration instead of chest tube drainage.
Detailed description
The chest tube drainage and needle aspiration are widely used first step techniques in spontaneous pneumothorax, thus present randomized controlled trial (RCT) aims to compare the efficacy of abovementioned techniques, as well as long-term outcomes. The study protocol has been confirmed by the ethics committee of AJA University. In current multi-center single-blinded RCT, all patients admitted with primary spontaneous pneumothorax will be enrolled study and written consent form provided by patients, simultaneously. With due attention to the success rate of 18% provided in a previous study comparing primary spontaneous pneumothorax treatment procedures and the study power of 80% and the confidence coefficient of 0.05, study population calculated to include 64 patient, which increased to 70 patients with taking 10% of falling risk into consideration. Using Randlist software, patients will be randomly assigned to study groups including (A) chest tube drainage and (B) needle aspiration. Subsequently, all patients will undergo one-year follow-up and will be evaluated in terms of treatment success rate and pneumothorax recurrence. In chest tube drainage group, while the patient is positioned in the supine position and subsequent to local anesthesia administration via lidocaine 2%, F16 or F20 (based on patients physical status) sterile plastic tube will be implemented at the level 4th or 5th intercostal space through the midaxillary line. However, in needle aspiration group, patients will be positioned semi-supine. Subsequently, G16 intravenous angiocath will be inserted through the midclavicular line at the level 2nd or 3rd intercostal space. The catheter needle will be removed and catheter will be fixed using sterile sticks. A three-way valve will be connected to the external end of the catheter and a 50 ml syringe will be connected to the valve. The air suction will be performed using 50 ml syringe till end of the air suction or up to 3.5 liters of air suctioning. Hypothesis of present trial are as follows: a) repetitive needle aspiration may lead to higher treatment success rate in patients with primary spontaneous pneumothorax, in comparison to chest tube drainage, b) needle aspiration may result in reduction of hospital admission duration in patients with primary spontaneous pneumothorax compared to chest tube drainage, c) the rate of spontaneous pneumothorax recurrence during one-year follow-up might be lower in patients who undergo needle aspiration instead of chest tube drainage.
Interventions
PROCEDUREChest tube drainage
In this group, in the supine position and subsequent to prepping and draping and local anesthesia administration via lidocaine 2%, F16 or F20 (based on patients physical status) sterile plastic tube will be implemented at the level 4th or 5th intercostal space through the midaxillary line. Subsequently, the external end of the tube will be connected to water sealing bottle and water bubbles coming out will be considered as proper chest tube insertion.
PROCEDURERepetitive needle aspiration
In this group, prior to needle aspiration, patients will take the semi-supine position. Subsequent to local anesthesia via lidocaine 2%, as well as prepping and draping, G16 intravenous angiocath will be inserted through midclavicular line at the level 2nd or 3rd intercostal space. Air bubble inside the lidocaine syringe will be considered as needled entrance to pleural cavity, thus 5-10 cm of the angiocath will be import to inside of the cavity. The catheter needle will be removed and catheter will be fixed using sterile sticks. A three-way valve will be connected to external end of the catheter and a 50 ml syringe will be connected to the valve. The air suction will be performed using 50 ml syringe till end of the air suction or up to 3.5 liters of air suctioning.
Sponsors
AJA University of Medical Sciences
Tabriz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Since patients are alert and conscious, therefore we are unable to blind the participants. However, care provider will not take part in the data acquisition and outcome analysis. The investigator and outcome assessor will be blinded to patients allocated group and treatment type provided in each patients.
Intervention model description
Patients will be randomly and equally assigned to study groups, as follows: group (a) will undergo chest tube drainage implementation and group (b) will undergo repetitive needle aspiration till pnuemothorax resolution.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged more than 18 years old * Symptomatic primary spontaneous pneumothorax or intervention-needed spontaneous pneumothorax (pneumothorax more than 20% in volume due to Light criteria)
Exclusion criteria
* Tension pneumothorax * bilateral severe respiratory failure * demand for mechanical ventilation * bilateral pneumothorax
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pneumothorax recurrence during one-year | One year postoperative | Will be defined as the rate of pneumothorax recurrence until postoperative one-year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful treatment rate | Postoperative day 1 and postoperative day 7 | Is defined as completely resolved pneumothorax during admission. |
| Length of hospital admission | Through hospital admission, an average of 10 days | will be calculated from the time of the operation to time of discharge. |
| Operation time | During procedure | Will be calculated from the time of skin incision to completing the procedure including complete chest tube insertion in chest tube group or complete air suction or up to 3.5 liters of air suction in needle aspiration group. |
| Procedure induced complications | Postoperative day 1, Postoperative day 3, Postoperative day 7, Postoperative month 1, | Includes all complications occurred during or after procedure during hospital stay. |
| Pneumothorax size | Before procedure, 1 hour after procedure, 48 hours after procedure, one-week after procedure | Will be calculated by Light's formula using chest radiography |
Countries
Iran
Contacts
Primary ContactAli Ramouz
Outcome results
None listed