Trial document





This trial has been registered retrospectively.
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  DRKS00006273

Trial Description

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Title

Normobaric hyperoxia for treatment of pneumocephalus after posterior fossa surgery in the semisitting position: a prospective randomized controlled trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Semisitting position is routine positioning for patients, who undergo posterior fossa surgery. This position associates, however, commonly with accumulation of intracranial air, so-called pneumocephalus. Normobaric oxygen has been suggested to be effective to treat pneumocephalus, since oxygen is able to replace nitrogen by increasing the diffusion gradient for nitrogen between the air collection and the surrounding tissue.
The aim of this prospective randomized controlled trial is to prove, whether administration of normobaric hyperoxia at FiO2 100% over an endotracheal tube (ETT) for 3 hours might accelerate the resorption of postoperative supratentorial pneumocephalus after posterior fossa surgery in the semisitting position. We hypothesized that patients who will be treated with normobaric hyperoxia at FiO2 100% via endotracheal tube for 3 hours will show a significantly volume change and a higher resorption rate of postoperative pneumocephalus as compared to untreated patients. Furthermore, the efficacy of normobaric hyperoxia at FiO2 of 100% on attention, as measured by the Stroop color-word interference tests, and on alertness, as noted on the Stanford Sleepiness Scale, will be compared and analyzed.
This study was initiated to assess treatment possibility of normobaric hyperoxia for inpatients, who underwent posterior fossa surgery in our own department. The study was registered in the German Clinical Trials Register retrospectively because of the recruitment of patients was performed for inpatients only.
A total of 44 patients aged 18 to 80 years who will undergo posterior fossa surgery in the semi-sitting position (as performed routinely in ours institution), will be randomized and evaluated after written informed consent are obtained. Patients randomized to the treatment group will be ventilated with normobaric hyperoxia at FiO2 100% via the endotracheal tube (ETT). Patients randomized to the control group will be weaned off anaesthesia and will then be extubated. The results will be statistically evaluated.

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Brief Summary in Scientific Language

This study aim to analyze the effect of administration of normobaric hyperoxia at FiO2 100% over an endotracheal tube (ETT) for 3 hours on pneumocephalus after posterior fossa surgery in the semisitting position.

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Organizational Data

  •   DRKS00006273
  •   2014/07/02
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  •   yes
  •   Approved
  •   5374, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

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Health Condition or Problem studied

  •   postoperative pneumocephalus
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Interventions/Observational Groups

  •   Patients randomized to the treatment arm will be ventilated with FiO2 = 100% at 1.0 ATA via the ETT for a period of 3 hours, starting immediately after their admission to the neurosurgical ICU. Subsequently, they will be weaned off from ventilation and will be extubated after completion of normobaric hyperoxia.
  •   Patients randomized to the control arm will be weaned off from ventilation and then will be extubated.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

1. The mean change of air volume between CT scan performed immediately and 24 hours after completion of surgery.
2. The air resorption rate (the mean change of air volume / hour).

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Secondary Outcome

1. Attention at 24 hours after completion of surgery: Stroop color-word interference tests
2. Alertness at 24 hours after completion of surgery: Stanford Sleepiness Scale

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2010/08/30
  •   44
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

- Patient’s age above 18 years
- Surgery with standard anaesthetic and ventilation procedures
- Postoperative course must be uneventful without any complication.
- CT scan show intracranial air collection of 30 ml or more.

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Exclusion Criteria

- Patients with a history of any cardiac disease or previously cardiac surgery, any pulmonary disease, chronic obstructive pulmonary disease (COPD), chronic cough or dyspnoe, abnormal chest X-ray, or previously pulmonary surgery - Patients, who will need, for whatever reason, a CSF drain or prolonged postoperative ventilation
- Pregnant or breastfeeding women

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Addresses

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    • Medizinische Hochschule Hannover
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Klinik für Neurochirurgie Medizinische Hochschule Hannover
    • Mr.  Dr. med.  Bujung  Hong 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Klinik für Neurochirurgie Medizinische Hochschule Hannover
    • Mr.  Dr. med.  Bujung  Hong 
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Neurochirurgie Medizinische Hochschule Hannover
    • 30625  Hannover
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/04/11
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Trial Publications, Results and other Documents

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