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A study done to compare the accuracy of one technique over pulse oximetry to detect a drop in oxygen level in the blood.

An observational study to determine the accuracy of Oxygen Reserve Index (Ori) to predict impending desaturation in patient’s undergoing procedures under apnoea. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/12/030112
Enrollment
50
Registered
2020-12-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx Health Condition 2: C30-C39- Malignant neoplasms of respiratory and intrathoracic organs

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Dr Jeson R Doctor
Lead Sponsor
Dr Sohan Solanki
Collaborator
Dr Urmila Phad
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults 18 - 80 years’ old 2. American Society of Anesthesiologists (ASA) physical status classification system:1 or 2 3. Any patient undergoing any procedure under general anaesthesia with apnoea and apnoeic oxygenation. e.g. direct laryngoscopic/ microlaryngoscopic evaluation or laser surgery for head and neck cancer, tracheal dilatation or stenting done under apnoeic oxygenation.

Exclusion criteria

Exclusion criteria: 1. Any patients with respiratory ailments (e.g. chronic obstructive pulmonary disease, asthma) or poor pulmonary function- Objective parameter to identify poor effort tolerance is ability to climb less than 1 flight of stairs. 2. Patients with baseline saturation less than 95% on room air. 3. Expected difficulty in tracheal intubation due to insufficient mouth opening and trismus where an awake fibreoptic intubation is planned. 4. Patients with stridor or an obstructed airway. 5. Patients with nail polish or Henna on fingers and nails- in whom the pulse oximeter readings may not be accurate. 6. No informed consent 7. Inability to wear the sensor due to deformity or hypoperfusion of the fingers

Design outcomes

Primary

MeasureTime frame
To find out the time lag between the ORI alarm at 0.24 and Sp02 to drop to 95%. Timepoint: The corresponding SpO2 and ORI values will be recorded every 5 seconds for 3 minutes. In case the ORI and SpO2 does not drop in 3 minutes the time at which ORI drops to 0.24 and Spo2 drops to 95% will be noted from the time of apnoea. The time interval between the ORI alarm and the fall in SpO2 to 95% will also be recorded.

Secondary

MeasureTime frame
Time taken, for the ORI to rise up to 0.24 and the SpO2 to rise to 100% after resuming ventilation and the time difference between the two.Timepoint: Oxygenation with anaesthesia breathing circuit will be resumed once the patient starts desaturating to less than 95%. The time taken for the ORI to rise back to 0.24 and SpO2 to rise to 100% after reoxygenation will also be noted in seconds from the time of resuming of ventilation of the patient.

Countries

India

Contacts

Public ContactDr Urmila Phad

Tata Memorial Hospital Mumbai

jesonrdoctor@gmail.com09820054956

Outcome results

None listed

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