High Concentration Oxygen Therapy for Pneumocephalus in Chronic Subdural Haematoma: A Prospective Observational Study

NCT05143216 | Unknown

• 1 other identifier: WON-20210111-18486
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Normobaric oxygen therapy was shown to be effective in reducing post craniotomy pneumocephalus. Theoretical assessment of normobaric oxygen therapy in treating pneumocephalus has shown that a higher level of oxygen concentration will significantly decrease the time for absorption of pneumocephalus. The therapeutic efficacy is not fully established in patients with chronic subdural hematoma after burr hole drainage. Both radiological outcomes and clinical outcomes would be evaluated.

Conditions

Chronic Subdural Hematoma

Keywords

Chronic subdural hematoma; Oxygen therapy

Outcome Measures

Primary Outcomes (3)

• Changes in pneumocephalus volume

  Changes in pneumocephalus volume

  24 hours

• Changes in pneumocephalus volume

  Changes in pneumocephalus volume

  48-72h hours

• Recurrence

  6 month

Secondary Outcomes (1)

• Modified Rankins Scale

  3 month, 6 month

Study Arms (1)

Chronic subdural haematoma post burr-hole drainage

Chronic subdural haematoma post burr-hole drainage

Other: Low concentration oxygen group: Room air (0-2Litre Oxygen via Nasal Canula); Other: High concentration oxygen group: Room air (12-15Litre Oxygen via Non-rebreather Mask)

Interventions

Low concentration oxygen group: Room air (0-2Litre Oxygen via Nasal Canula) OTHER

Low concentration oxygen group: Room air (0-2Litre Oxygen via Nasal Cannula)

Chronic subdural haematoma post burr-hole drainage

High concentration oxygen group: Room air (12-15Litre Oxygen via Non-rebreather Mask) OTHER

High concentration oxygen group: Room air (12-15Litre Oxygen via Non-rebreather Mask)

Chronic subdural haematoma post burr-hole drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic subdural haematoma

You may qualify if:

• Age greater than or equal to 18 years-old. Presence of chronic subdural haematoma (CSDH) as diagnosed radiologically either by computed tomography (CT) brain scan or magnetic resonance imaging (MRI).
• Treatment of CSDH by burr-hole evacuation. Post operative pneumocephalus, as evidenced from post-operative CT Brain or MRI brain.
• Negative test to SARS-nCoV-2, as evidenced by either deep throat saliva rapid test, deep throat saliva PCR test, nasopharyngeal swab real-time PCR test, or nasopharyngeal swab rapid test within seven days.

You may not qualify if:

• Presence of pre-existing respiratory conditions such as chronic obstructive pulmonary disease (COPD) and hence not suitable for oxygen therapy.
• Any pre-existing illness that renders the patient moderately or severely disabled before diagnosis with CSDH, such as a history of central nervous system infection.
• CSDH arising from secondary causes, such as intracranial hypotension, thrombocytopenia, etc.
• Any evidence or suspicion that there is communication between the pneumocephalus with the air cells (e.g. such as mastoid air cells) or air sinuses (e.g. frontal sinus).
• Patients that need an additional procedure e.g. epidural blood patch, etc. Complications arising from the burr-hole operation or subdural drain insertion such as hemorrhage or surgical site infection requiring surgical intervention or deemed to affect the patient's long-term functional outcome.
• Patients already on long-term steroid for pre-existing medical conditions. Patients who received instillation of subdural urokinase or tissue plasminogen activator via the subdural catheter(s).
• Participation in other clinical trials within four weeks upon recruitment. Pregnancy or on breastfeeding. Any other reasons that the researchers consider the patients to be unsuitable.

Sponsors & Collaborators

• Dr. David Yuen Chung CHAN: lead

Study Sites (1)

Division of Neurosurgery, Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, 852, Hong Kong

RECRUITING

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• David YC CHAN

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David YC CHAN

CONTACT

852-35052211; david.yc.chan@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor (Neurosurgery)

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 3, 2021
• Study Start: May 6, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 31, 2023
• Last Updated: July 28, 2022

Record last verified: 2022-07

Locations

HK (1)