Usage of High Flow Nasal Cannula in Preventing Desaturations in Elderly Patients Going for Lower Limb Surgeries

NCT ID: NCT06054022

Last Updated: 2023-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-07

Study Completion Date

2021-12-31

Brief Summary

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To study the effect of high flow nasal cannula in comparisons with nasoprong used intraoperatively in patients oxygenation status

Detailed Description

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To observe the effect of high flow nasal cannula used intraoperatively compared to normal oxygen therapy (nasoprong) at a same fraction of inspired oxygen (FiO2) in elderly patients who are going for orthopaedic surgeries under central neuraxial block.

oxygenation will be access with intermittent blood gas. atelectasis will be access via chest x-ray , compared to a baseline chest x-ray, validated by a blinded radiologist

Conditions

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Hypoxemia During Surgery Atelectasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
there will be no masking except for the radiologist who compares the postoperative chest x-ray with the baseline

Study Groups

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patient receiving high flow nasal cannula (A)

Patient will be put on high flow nasal cannula at a fixed flow of 50L/min, at Fio2 0.3% throughout surgery. Oxygen therapy will be discontinued once surgery ends. FiO2 will be titrated by 0.1 increment to a SpO2 of ≥94%.

Group Type EXPERIMENTAL

high flow nasal cannula

Intervention Type DEVICE

high flow nasal cannula provides heated and humidified gas to the airways via nasal prongs at a prescribed accurate fraction of inspired oxygen (FiO2) ranging from 0.21 to 1.0 and with a higher flow rate of up to 60 litres per minute

patient receiving nasoprong oxygen 2 L/min

Patient will be put nasoprong oxygen 2L/min throughout surgery. Oxygen therapy will be discontinued once surgery ends. FiO2 will be titrated by 0.1 increment to a SpO2 of ≥94%.

Group Type ACTIVE_COMPARATOR

nasoprong oxyen 2Litres per minute

Intervention Type DEVICE

nasoprong @L/min will deliver approximately a FiO2 of 0.3. subsequently, if incremental O2 is needed, patient will be provided with ventimask 40% and so forth

Interventions

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high flow nasal cannula

high flow nasal cannula provides heated and humidified gas to the airways via nasal prongs at a prescribed accurate fraction of inspired oxygen (FiO2) ranging from 0.21 to 1.0 and with a higher flow rate of up to 60 litres per minute

Intervention Type DEVICE

nasoprong oxyen 2Litres per minute

nasoprong @L/min will deliver approximately a FiO2 of 0.3. subsequently, if incremental O2 is needed, patient will be provided with ventimask 40% and so forth

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. American Society of Anesthesiologists (ASA) I, II or III patients.
2. Patients age 60 years and above
3. Patients scheduled for total knee replacement therapy and hip surgeries under central neuraxial block under the elective and emergency list.

Exclusion Criteria

1. Patients with pre-operative spO2\<94%
2. Patients delirious or demented / unable to give consent.
3. Patients with pre-existing pneumonia (defined as the initiation of antibiotics for suspected infection with one or more of the following: new or changed sputum; new or changed lung opacities; fever; white blood cell count \>12 × 109 litre-1 )15
4. BMI ≥35
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universiti Kebangsaan Malaysia Medical Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Syarifah noor nazihah binti sayed masri, MD

Role: PRINCIPAL_INVESTIGATOR

National University of Malaysia

Locations

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Universiti Kebansaan Malaysia

Cheras, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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FFP-2020-245

Identifier Type: -

Identifier Source: org_study_id

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