Summary: Hyperbaric Oxygen therapy is now given under carefully controlled regimen in experimental situations like cerebral palsy and similar diseases, that are not universally recognized as indications for HBOT. We are giving below the protocol for an USA based research project for use of HBOT in Cerebral Palsy. Last revised January 21, 2007.

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Dr. Chadha has opened a state of the art Hyperbaric Oxygen Therapy Centre facility in Scarborough Toronto Ontario. He is currently treating Cerebral Palsy, Stroke, MS, Traumatic Brain Injury and, sports injury under investigational/experimental protocol. Dr. Uday Chadha is former Chief of Neonatology and Director of Special Care Nursery at Ottawa Hospital. He is American and Canadian board certified in Neonatal – Perinatal Medicine and Pediatrics. He is also on the Board of Directors of 'The International Society for Hyperbaric Oxygenation in Cerebral Palsy and the Brain Injured Child.'

The fee per session charged there is $ 95-125 depending on the chamber used. In contrast, the fees at Delhi are about Rs.2000 ($45) per session, with concessions available for multiple use as per rules.

PROTOCOL FOR Hyperbaric Oxygen Therapy

1. Patients will be treated with oxygen at 1.5 ATA for one hour once a day for 40 days. 
2. The initial session will consist of 40 one-hour treatments, preferably once a day. There will be a second group of patients from out of town which will be treated twice a day for six days a week, the gap between the two treatments will be minimum of 4 hours.

The long term maintenance therapy is not yet defined, but we feel that once a week for one hour would be a good starting point to assess the need for long term therapy.

MEDICAL HISTORY (CHILD) (modified for our use)

Date ______________ ; Time ____________

Name _______________________________

Age _____, Sex M/F ____

Chief complaints cerebral palsy/stroke/multiple sclerosis/developmental delay/autism/prematurity

Pregnancy normal/abnormal (describe if abnormal)

Birth history

Birth wt.: _____ Pounds; APGAR score _______ ; Gestational age weeks. ___________

Normal delivery

Complication of delivery

Past Medical History Infections Seizures

Asthma ______ ; High B.P. _________

Immunization ________________________________ ; Allergy ______________________________

Medications

Developmental history ____________________________; Can sit yes/no ___; Can stand yes/no ______

Can walk yes/no ______; Can speak yes/no _____

How many words vocabulary

Tone spasticity yes/no _____

Fine motor skills ___________________________; Can hold objects yes/no _______ ; Can write y/n _________

Lab Investigations

MRI

CT

SPECT

Previous HBO Sessions Where?

Complications of Previous HBOT if any (Please describe)

Physical exam. B.P.

Gen Exam

Eye / ENT

Heart

Chest

Abd.

CNS

A)

    PLAN)

Medical History Attendant /Parent Date

Name Age Sex m/f

Address

Date of Birth

Medical Problems:

Heart Yes/No

Lungs Yes/NO

Ears Yes/No

CNS Yes/No

High Blood Pressure Yes/No

Other

Past Medical History: Please give details of medical conditions that you think we should know, if need be write on the back page:

Allergies No/Yes: Give details

Medications

Physical Exam. B.P. Pulse

Gen. Exam

Eye/ENT

Heart

Chest

Abd.

CNS

Other

Risks, Benefits and experimental nature of HBO Therapy discussed in details.

CONFIRMATION OF INSTRUCTIONS

This is to certify that __________________________ (patient or patient's parent /guardian) has been instructed in the following safety instructions with regards to Hyperbaric Oxygen Therapy for themselves and/or their child.

Safety Instructions

The chamber is very safe.

Fire safety is assured with fire proof materials. The patient (and accompanying parent for small children) plays an active part in the maintenance of safety in the chamber.

All oil or alcohol based make up, carbonated drinks and smoking should be withheld at least 2 hours prior to the treatment.
Water bottles can be taken into the chamber.
100 percent cotton clothing is worn in the chamber.

The following materials are not allowed in the chamber.

• Deodorant
• Glycerine based products
• Gum or candy
• Hair spray
• Moustache wax
• Oil based products
• Skin lotions
• Smoking materials
• Strong colognes
• Synthetic materials
• Toys
• Vaseline based products
• Watches
• Wigs or hair pieces

Patient's Signature (Parent/guardian if minor); Date

______________________________________ ______________

CHECK LIST FOR THE PARENTS BEFORE AND AFTER THERAPY

Name Age ______ Diagnosis _________

Number of sessions received so far

Improved: yes no

1. Fine motor functions ___ ___
2. Gross motor functions ___ ___
3. Gait analysis ___ ___
4. Child's general behavior (same/ better) ___ ___
5. Burden of care (Improved: yes /no) ___ ___
6. Does the child sleep through the night? ___ ___
7. Has the quality of sleep improved? ___ ___
8. Has the quality of life improved? ___ ___
9. Has the spasticity of the child improved? ___ ___
10. Has the vocalization of the child improved? ___ ___
11. Has toilet training improved? ___ ___
12. Has the general intelligence of the child improved? ___ ___
13. Are there any other comments that the parents want to include that they think are important from the study point of view? How do you think your child has or hasn't improved?

INFORMED CONSENT FOR HYPERBARIC OXYGEN THERAPY

(Must be completed before first treatment)

I,________________________, resident of __________________________________________________ and the _______________ of ______________ , a child diagnosed by competent medical authorities after all necessary examinations and investigations, as suffering from cerebral palsy, do hereby give Foundation for Spastic and Mentally Handicapped Persons, its main activity center UDAAN for the Disabled, and Apollo Hospital where HBOT will be carried out, my consent to administer Hyperbaric Oxygen Therapy to my ________________________as treatment for the following condition (s):_______________________________________________________ In doing so, I acknowledge that I have been advised for the following.

Although Hyperbaric Oxygen Therapy is considered adjunctive therapy for several conditions such as decompression, gas gangrene and carbon monoxide poisoning, and such as is generally accepted and recognized as effective in the medical community its use is considered "investigational" by many physicians when it is used to treat certain illnesses, injuries and disorders such as cerebral palsy.

Thus I understand the therapy to which I am agreeing may be characterized as "investigational and experimental".

The known risks of Hyperbaric Oxygen Therapy include: temporary visual changes (near sightedness), ear pressure –sinus pressure (similar to pressure changes experienced during an airplane flight), in the worst case scenario there is a risk of rupture of ear drums. Fire hazard (extremely remote) and confinement anxiety (claustrophobia) are some of the other side effects. If the pressure is increased beyond 3.0 ATA the risk of oxygen toxicity increases in the form of seizures. These risks have been fully explained to me and I have had the opportunity to ask and have answered to my satisfaction any questions regarding the safety of this treatment.

No representations have been made to me by Foundation for Spastic and Mentally Handicapped Persons, its main activity center UDAAN for the Disabled, or Apollo Hospital where HBOT will be carried out, or any other person associated with them implying that treatments to which I hereby consent will produce any specific result or benefit. This therapy in children is experimental. No representations have been made, except as set forth in this Informed Consent concerning the accuracy, validity or efficacy of Hyperbaric Oxygen Therapy.

The cost of performing Hyperbaric Oxygen Therapy is Rs. _______________ as applicable for my ___________________________ . I fully understand and expressly agree that I will be personally responsible for full cost of services rendered.

Physician/Manager statement

I , the undersigned , have fully explained the procedure to the above Parent/ patient/guardian.

Signature Date

The risks of Hyperbaric Oxygen Therapy and the the investigational nature of such therapy has been explained to me in detail and I have had the full opportunity to ask questions and such have been answered to my satisfaction.

Patient/Parent/Guardian Signature Date ___________________

Witness Signature Date _____________________

SAFETY PRECAUTIONS

Following points needs be checked before patient/attendant enters the chamber

Check list for Technician

Before the patient or the parent/guardian/or any designated family member /friend enters the chamber following safety precautions must be discussed and documented in the chart.

1. Complete physical examination examination of the parent and or attendant must be completed either by Dr Uday Chadha or the family Physician. This is the responsibility of parents to organize before starting the therapy. They can call the clinic to book an appointment or get a complete physical examination 's copy to the clinic to be placed in the patients chart.
2. Safety instructions needs to be discussed with the family and they have to signed the sheet that this has been discussed with them and that they understood these instructions, and that if they had any questions that have been discussed with them in detail and to their satisfaction, for example no make up, no jewelry .no nail polish, only 98-100 percent cotton clothing , no hair gel, no contacts ,no glasses, no carbonated drinks 2 hours prior to the session, no smoking 2 hours prior to treatment. A copy of this should be in the chart.
3. Instructions have been given to the family and patient as to how to clear the ears while in the chamber for example chewing a gum or giving water to the child to swallow.
4. A deposit of Rs.____________  has been received (only in cases where applicable) as full payment 
5. Patients needs be continuously monitored while they are in the chamber if there is any concerns regarding the health of the patient the treatment should be discontinued, and patient assessed.
6. Informed consent needs to be in the chart signed by the patient/guardian and the medical director or the manager.
7. Patients/families need to be told that the choice of chamber the child goes in will be at the sole discretion of staff members keeping the best interest of child in mind. This needs to be documented ,signed by the patient/family and copy kept in the chart.
8. Tech needs to ask the patient/family if they are feeling healthy if not the session should be postponed.
9. The blood pressure of every adult going into the chamber whether attendant or patient should be documented in the chart, and it is the responsibility of the tech to check before patient goes in the chamber. If the Blood pressure is above 170 over90 mm of mercury that person will not go into the chamber, until he/she has seen the family doctor.
10. There should be at least two people in the clinic one of them should be technician.

INSTRUCTIONS FOR PATIENTS UNDERGOING HYPERBARIC OXYGEN THERAPY

1. Only 100% cotton undergarments and clothing bought from here are allowed in the chamber. We insist that you remove all synthetics, nylons, and all other fabrics.
2. Do not go into the chamber with and heavy grease or oils on the skin or hair (i.e. sun lotion, perfumes, hair spray, nail polish, make up, etc.)
3. Please remove watches, wigs, hairpins, and heavy jewelry. Also remove unnecessary prosthetic devices such as hearing aids, and contact lenses.
4. Because smoking constricts the blood vessels we ask that you stop smoking while taking the treatments, or at least refrain for two hours prior to and after each treatment.
5. Do not take any foreign object into the chamber with you. If you wish to anything with you into the chamber (except gum or candy) please check with the staff prior to doing so.

   Thank you for your cooperation.

Signature___________________ Date_________________

UNFORESEEN CIRCUMSTANCES AND WAITING TIME POLICY

Please be aware there would be times during your treatment when for circumstances beyond our control we may not be able to keep the schedule on time , so be patient we would try to do our best to avoid such circumstances.

But the management does not take any responsibility for such occurrences.

Parent/Patient/Guardian's signature

Date___________________

VISITOR POLICY

Please be advised that for safety reasons and limited space in the chamber room not more than one family member will be allowed at a given time in the chamber room except in exceptional circumstances (at the discretion of the management.)

The rest of family should wait in the waiting area.

Your cooperation will be greatly appreciated

Signature of Patient/Parent/Guardian

Date__________________________

ASSIGNMENT OF CHAMBER POLICY

The assignment of chamber will be at the discretion of management keeping the safety of the children in mind.

Parents/patient/Guardian's Signature

Date________________

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