CTRI

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CTRI Number

CTRI/2024/04/065736 [Registered on: 16/04/2024] Trial Registered Prospectively

Last Modified On:

10/04/2024

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Prospective Observational Study

Study Design

Other

Public Title of Study

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

Scientific Title of Study

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

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
901030_Version 1.1 dated 05.03.24	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Reshma Ambulkar
Designation	Professor and Head
Affiliation	Tata Memorial Centre
Address	Department of Anesthesia Critical care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai Mumbai (Suburban) MAHARASHTRA 410210 India
Phone	9821790448
Fax
Email	rambulkar@hotmail.com

Details of Contact Person
Scientific Query

Name	Dr Reshma Ambulkar
Designation	Professor and Head
Affiliation	Tata Memorial Centre
Address	Department of Anesthesia Critical care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai MAHARASHTRA 410210 India
Phone	9821790448
Fax
Email	rambulkar@hotmail.com

Details of Contact Person
Public Query

Name	Dr Reshma Ambulkar
Designation	Professor and Head
Affiliation	Tata Memorial Centre
Address	Department of Anesthesia Critical care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai MAHARASHTRA 410210 India
Phone	9821790448
Fax
Email	rambulkar@hotmail.com

Source of Monetary or Material Support

195 Montague Street, 14th Floor, Brooklyn, NY 11201, USA

Primary Sponsor

Name	Lifebox foundation
Address	195 Montague Street, 14th Floor, Brooklyn, NY 11201, USA
Type of Sponsor	Other [Non Profit Organisation]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Reshma Ambulkar	Advanced Centre for Treatment, Research and Education (ACTREC)	Department of Anaesthesia, Critical Care and Pain, 7th Floor, RRS Building, ACTREC, Kharghar Mumbai (Suburban) MAHARASHTRA	9821790448 rambulkar@hotmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Tata Memorial Centre_Institutional Ethics Committee III	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Intervention	NA	Nil
Comparator Agent	NA	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	75.00 Year(s)
Gender	Both
Details	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.

ExclusionCriteria

Details

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.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Proportion of patients with Occult hypoxemia	Pulse oximetry readings will be obtained at the time of intra-operative and immediate post-operative sampling for ABGA

Secondary Outcome

Outcome

TimePoints

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.

At the time of intra-operative and immediate post-operative sampling for ABGA

Target Sample Size

Total Sample Size="488"
Sample Size from India="488"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

22/04/2024

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Aim: To identify and quantify the impact of skin colour on oxygen saturation (SpO2) levels measured by pulse-oximeter.

Objectives:

Primary objective:

1. To identify the incidence of â€œoccult hypoxemiaâ€ (defined under outcome measures sub-section) in individuals of different skin colour grades.

2. Secondary objectives:

3. To quantify the bias (defined under outcome measures sub-section) in arterial saturation measurement due to skin colour and develop a corrective factor for each skin tone.

4. To compare post-operative outcomes of patients with and without occult hypoxaemia.

To compare serum lactate levels between patients with and without occult hypoxaemia.

Study design: This is a prospective observational study. Skin colour of study participants will be quantified using the Fitzpatrick (17) as well as the Monkâ€™s skin tone (MST) scale (18). Test measurement of SpO2 will be done by the Lifebox pulse-oximeter and the pulseoximeter currently in use at the study site. Pulse-oximeter readings will be taken intra-operatively at two time-points at least 2 hours apart. SpO2 measured by an arterial blood gas analysis (ABGA) will be the gold-standard against which the test measurement will be compared. The test measurement will be taken at the time of collection of the arterial blood sample for ABGA. The ABGA will be done as per the discretion of the anaesthesiologist, as per standard intra-operative management protocols. The difference between the test and gold standard SpO2 measurement for different skin tones will be studied and quantified. Proportion of patients with occult hypoxaemia will be identified for each skin grade.