*A prospective, randomised trial in pneumothorax therapy: manual aspiration versus conventional chest tube drainage.*

The aim of pneumothorax therapy is to restore lungexpansion and to prevent a
pneumothorax in the future. Nowadays, conventional chest tube drainage is the
standard therapy. Manual aspiration is as effective as the conventional
drainage technique and has similar risks, according to a prior trial. However,
a comparing trial in the Netherlands has never been performed. Benefits might
be a shorter hospital stay with lower costs.

To evaluate the efficacy of manual aspiration in comparison to conventional
chest
tube drainage in pneumothorax therapy:

1.whether the lung will expand by means of clinical and radiological findings.
2.whether manual aspiration will shorten hospital admission.

prospective single-centre, open randomised trial.

Onehundredandfourteen patients with a first episode of a symptomatic
pneumothorax admitted to the ER of the hospital or an asymptomatic
pneumothorax with a size of >= 20 % as estimated by Light*s formula are
recruited
and will be followed-up for one year, after they have given written informed
consent. Exclusion criteria are a previous pneumothorax or lung fibrosis in
medical history, pregnancy, comorbidity limiting decision making or a prior
randomisation. Patients will be randomised by a computer minimisation program
for the cause of pneumothorax (spontaneous or traumatic) the presence of
smoking and gender and will undergo manual aspiration or conventional chest
tube drainage:

Manual aspiration:
After skin desinfection and field preparation, an angio I.V. catheter with a
diameter of 1.3 mm will be introduced in the second or third intercostal space
midclavicular of the affected site after local anaesthesia (lidocaïne 1%).
In case of extreme obesity a pneumocatheter will be used. After fixation to the
skin, the I.V. catheter will be connected with a three-way valve to a 50 ml
syringe and air will be manually aspirated until a resistance is felt and no
air is
acquired any longer. In case of success with an expanded lung at the chest
X-ray,
the drainage system will be disconnected and patient will be observed during 24
hours. If manual drainage has failed, no second attempt will be made and
conventional drainage will be chosen. After the observation period a new chest
X- ray will be made with a final evaluation. When the lung is still expanded at
the
chest X-ray, discharge will follow. When no lung expansion is reached or in case
of absorption of > 4000 ml air (prolonged air leak), conventional chest tube
drainage will be performed.

Conventional chest tube drainage:

After skin desinfection and field preparation, a pneumocath catheter with a
diameter of 2.7 mm will be introduced in the second or third intercostal space
in the axillary line of the affected site after local anaesthesia (lidocaïne
1%).
The drain will be connected to a drainage system with a negative pressure of
- 10 mmHg H2O. When airway leakage has ceased, expansion of the lung will be
radiologically evaluated. The drain will be clipped for four hours. When the
expansion of the lung still exists after four hours (chest X-ray), the drain
will be
removed and patient will be discharged.

After discharge patients are seen at day 14 and after one year at the
outpatient clinic with a chest X-ray to evaluate a possible recurrence of the
pneumothorax.

Conventional chest tube drainage:

After skin desinfection and field preparation, a pneumocath catheter with a
diameter of 2,7 mm will be introduced in the second or third intercostal space
in the axillary line of the affected site after local anaesthesia (lidocaïne
1%). The drain will be connected to a drainage system with a negative pressure
of -10 mmHg H2O. When airway leakage has ceased, lungexpansion will be
radiologically evaluated. The drain will be clipped for four hours. When the
lungexpansion still exists after four hours, the drain will be removed.

Manual aspiration:

After skin desinfection and field preparation, an angio I.V. catheter with a
diameter of 1,3 mm will be introduced in the second or third intercostal space
midclaviculair of the affected site after local anaesthesia (lidocaïne 1%).
In case of extreme obesity a pneumocath catheter will be used. After fixation
to the skin, the I.V. catheter will be connected with a three-way valve to a 50
ml
syringe and air will be manually aspirated until a resistance is felt and no
air is
acquired any longer. Expansion of the long will be confirmed radiologically
whereafter the drainage system will be disconnected. Finally the patient will be
observed during 24 hours and when the lung is still expanded at the chest
X-ray, discharge will follow. When no lung expansion is reached or in case of
absorption of > 4000 ml air (prolonged air leak), conventional chest tube
drainage will be performed.

The risks of manual aspiration and chest tube drainage techniques are the same.
Complications seem to be occur in only 1 % of the aspirations and they consist
of haematothorax, retained catheter tips, subcutaneous emphysema and vasovagal
reactions. The most important disadvantage is in case of an unsuccessfull
treatment by manual aspiration with a still consisting pneumothorax. Patients
in these situation have to undergo the conventional tube chest drainage at all.
The benefit of the investigational approach might be that patients are
discharged earlier from the hospital in case of success and it's
costeffectiveness.