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A trial to find out if the head end of the patients bed need to be raised if air enters the brain after a head injury.

Randomised controlled trial of the effectiveness of head end elevation versus no head end elevation for resolution of traumatic pneumocephalus

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009578
Enrollment
176
Registered
2017-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Pneumocephalus following head injury

Interventions

Intervention1: Elevation of the head end of the bed: Head end of the bed will be elevated by 30 degrees to 45 degrees and this angle will be verified twice a day using a smart phone application. Contr

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients with pneumocephalus detected by CT scan soon after head injury Pneumocephalus should measure at least 10 ml by volumetry in the initial scan or if volumetry cannot be done, the air bubble should measure 3 cm in all dimensions. If there are multiple specks of pneumocephalus, the total diameter in each of the two dimensions should be 3 cm so that the volume is approximately 10 ml by the formula axbxc divided by 2 where a, b and c are the dimensions in orthogonal planes.

Exclusion criteria

Exclusion criteria: 1)Patients who are pregnant in whom CT scans are relatively contraindicated or have to be limited 2)Patients whose pneumocephalus was detected more than 24 hours after the injury. 3)Preexisting CSF rhinorrhea or otorrhea 4)Patients who require immediate cranial neurosurgical intervention or are very likely to have surgery within 5 days

Design outcomes

Primary

MeasureTime frame
Resolution of pneumocephalusTimepoint: Five days after trauma. (fitth post-trauma day)

Secondary

MeasureTime frame
Hypostatic pneumoniaTimepoint: Day seven;Operative intervention for hypostatic pneumoniaTimepoint: 30 days after trauma;Post traumatic meningitisTimepoint: Day seven and day 30.

Countries

India

Contacts

Public ContactRahul Srivastava

JIPMER (Jawaharlal Institute of Post-graduate Medical Education and Research

gopalakrishnanms@gmail.com9345141431

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026