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A study to evaluate differences in amount of oxygen absorbed in blood by using pulse oximeter in brown skinned individuals

Discrepancies in peripheral oxygen saturation estimation by pulse-oximeter in brown-skinned individuals: the OXICOLOUR study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/04/065736
Enrollment
488
Registered
2024-04-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Sponsors

Lifebox foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing major elective oncologic surgery (For example, radical gastrectomy, pancreatic resection, hepatectomy, abdominal compartment resection, radical nephrectomy, retroperitoneal lymph node dissection, radical cystectomy, radical prostatectomy, colorectal resection, total abdominal hysterectomy and salpingo-oophorectomy, and cytoreductive surgeries). 2. Patients requiring an arterial line as part of their standard-of-care.

Exclusion criteria

Exclusion criteria: 1. Patients undergoing emergency surgery. 2. Hemodynamically unstable patients requiring inotrope support. Hemodynamically stable patients with elective low-dose intra-operative inotrope support of up to 0.05mcg/kg/min will still be included. 3. Haemoglobin less than or equal to 8g/dL at the time of surgery. 4. On mechanical ventilation prior to surgery. 5. Pre-existing local skin or nail disorders preventing accurate measurement of SpO2 by pulse-oximeter. 6. Patients with intrathoracic surgical procedures; to avoid potential confounding factors related to lung parenchymal resections, single-lung ventilation or mediastinal dissection.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with Occult hypoxemiaTimepoint: Pulse oximetry readings will be obtained at the time of intra-operative and immediate post-operative sampling for ABGA

Secondary

MeasureTime frame
1. Bias in measurement of arterial saturation 2. In-hospital mortality defined as death due to any cause from date of inclusion to date of discharge from the hospital. 3. Length of ICU stay to be measured in hours from time of shifting into ICU after surgery to time of transfer to the ward from ICU. 4. Post-operative extubation rate defined as proportion of patients being extubated at the end of surgery, prior to shifting from the operating room. 5. Duration of hospital stay defined as number of days from date of surgery to the date of discharge. 6. Post-operative pulmonary complications will be defined in accordance with the European Peri-operative Clinical Outcome (EPCO) definitions. 7. Serum lactate levels will be measured in the samples collected for arterial blood gas analysis. Mean and standard deviation of all intra-operative serum lactates levels of each patient will be calculated. Timepoint: At the time of intra-operative and immediate post-operative sampling for ABGA

Countries

India

Contacts

Public ContactDr Reshma Ambulkar

Tata Memorial Centre

rambulkar@hotmail.com9821790448

Outcome results

None listed

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