High Concentration Oxygen for Pneumocephalus After Evacuation of Chronic Subdural Haematoma

NCT04725851 | Unknown DMC

• 1 other identifier: NTEC-2021-0021
• Study Type: interventional
• Target: 36
• 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; Recurrence; Oxycephaly

Keywords

Chronic subdural hematoma; Oxygen therapy; Normobaric Oxygen; High concentration Oxygen; Pneumocephalus; Recurrence

Outcome Measures

Primary Outcomes (1)

• Changes in the volume of pneumocephalus after 24 hours of oxygen therapy

  Volumetric measurement of pneumocephalus from Computed Tomographic (CT) scan for the Head

  24 hours

Secondary Outcomes (16)

• Modified Rankins Scale (mRS)

  at baseline before admission, on admission, at 1 month, at 3 months and at 6 months.

• EuroQOL EQ-5D

  at 1 month, at 3 months and at 6 months.

• Glasgow Coma Scale (GCS)

  On admission, at 1 month, at 3 months and at 6 months.

• Recurrence rate, as defined by reoperation rate due to symptomatic recurrence

  Reoperation rate within six months, including the number of re-operations for CSDH during the same admission episode, as well as subsequent readmission for reoperation for CSDH.

• Changes in brain volume re-expansion

  after 24 hours of oxygen therapy and 1 week after oxygen therapy

Other Outcomes (3)

• Recurrence rate in BILATERAL Chronic Subdural Hematoma (CSDH)

  Within six months from the index operation

• Volumetric reduction in pneumocephalus in BILATERAL Chronic Subdural Hematoma (CSDH) after Oxygen therapy

  Within 24 hours after Oxygen therapy

• Improvement in mRS for BILATERAL Chronic Subdural Hematoma (CSDH)

  at 1 month, 3 months and 6 months

Study Arms (2)

High concentration Oxygen Therapy

EXPERIMENTAL

12-15 Litre/min O2 delivery via Non-Rebreather Mask (NRM) consecutively for 24 hours.

Procedure: High concentration Oxygen therapy

Room air or low concentration oxygen

PLACEBO COMPARATOR

Room air or low concentration oxygen (0-2 Litre/min O2 ) consecutively for 24 hours.

Procedure: Control: Room Air or Low concentration Oxygen

Interventions

High concentration Oxygen therapy PROCEDURE

FiO2 \>80% Oxygen (Delivered with 12-15L/min Non-rebreather Mask)

High concentration Oxygen Therapy

Control: Room Air or Low concentration Oxygen PROCEDURE

FiO2 \<30% Oxygen (Delivered with 0-2L/min Nasal Cannula)

Room air or low concentration oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• Presence of 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.
• 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

• Chinese University of Hong Kong: 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

Related Publications (10)

• Gore PA, Maan H, Chang S, Pitt AM, Spetzler RF, Nakaji P. Normobaric oxygen therapy strategies in the treatment of postcraniotomy pneumocephalus. J Neurosurg. 2008 May;108(5):926-9. doi: 10.3171/JNS/2008/108/5/0926.

  PMID: 18447708 BACKGROUND

• Dexter F, Reasoner DK. Theoretical assessment of normobaric oxygen therapy to treat pneumocephalus. Anesthesiology. 1996 Feb;84(2):442-7. doi: 10.1097/00000542-199602000-00024.

  PMID: 8602677 BACKGROUND

• Greif R, Akca O, Horn EP, Kurz A, Sessler DI; Outcomes Research Group. Supplemental perioperative oxygen to reduce the incidence of surgical-wound infection. N Engl J Med. 2000 Jan 20;342(3):161-7. doi: 10.1056/NEJM200001203420303.

  PMID: 10639541 BACKGROUND

• Xu F, Liu P, Pascual JM, Xiao G, Lu H. Effect of hypoxia and hyperoxia on cerebral blood flow, blood oxygenation, and oxidative metabolism. J Cereb Blood Flow Metab. 2012 Oct;32(10):1909-18. doi: 10.1038/jcbfm.2012.93. Epub 2012 Jun 27.

  PMID: 22739621 BACKGROUND

• Santarius T, Kirkpatrick PJ, Ganesan D, Chia HL, Jalloh I, Smielewski P, Richards HK, Marcus H, Parker RA, Price SJ, Kirollos RW, Pickard JD, Hutchinson PJ. Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1067-73. doi: 10.1016/S0140-6736(09)61115-6.

  PMID: 19782872 BACKGROUND

• Miranda LB, Braxton E, Hobbs J, Quigley MR. Chronic subdural hematoma in the elderly: not a benign disease. J Neurosurg. 2011 Jan;114(1):72-6. doi: 10.3171/2010.8.JNS10298. Epub 2010 Sep 24.

  PMID: 20868215 BACKGROUND

• Chan DYC, Poon WS, Chan DTM, Mak WK, Wong GKC. Chronic subdural haematoma during the COVID-19 lockdown period: late presentation with a longer interval from the initial head injury to the final presentation and diagnosis. Chin Neurosurg J. 2021 Jan 8;7(1):4. doi: 10.1186/s41016-020-00229-7.

  PMID: 33419483 BACKGROUND

• Chan DY, Woo PY, Mak CH, Chu AC, Li CC, Ko NM, Ng SC, Sun TF, Poon WS. Use of subdural drain for chronic subdural haematoma? A 4-year multi-centre observational study of 302 cases. J Clin Neurosci. 2017 Feb;36:27-30. doi: 10.1016/j.jocn.2016.10.039. Epub 2016 Nov 30.

  PMID: 27914805 BACKGROUND

• Chan DY, Chan DT, Sun TF, Ng SC, Wong GK, Poon WS. The use of atorvastatin for chronic subdural haematoma: a retrospective cohort comparison study. Br J Neurosurg. 2017 Feb;31(1):72-77. doi: 10.1080/02688697.2016.1208806. Epub 2016 Nov 23.

  PMID: 27881024 BACKGROUND

• Chan DYC, Sun TFD, Poon WS. Steroid for chronic subdural hematoma? A prospective phase IIB pilot randomized controlled trial on the use of dexamethasone with surgical drainage for the reduction of recurrence with reoperation. Chinese Neurosurgical Journal. 2015; 1(1):2.

  BACKGROUND

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Recurrence; Craniosynostoses; Pneumocephalus

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; Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Brain Injuries

Study Officials

• David YC Chan, MBBS, FRCS

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Wai S Poon, MBChB, FRCS

  Chinese University of Hong Kong

  STUDY CHAIR

Central Study Contacts

David YC Chan, MBBS, FRCS

CONTACT

852-35052624; david.yc.chan@cuhk.edu.hk

Wai S Poon, MBChB, FRCS

CONTACT

852-35051316; wpoon@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 27, 2021
• Study Start: July 26, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)