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NCT Number: NCT06054022

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

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

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Key information

Conditions

Hypoxemia During Surgery Atelectasis Hypoxia Lung Diseases Pathological Conditions, Signs and Symptoms Pulmonary Atelectasis Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Kebansaan Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with pre-operative spO2<94%
  • Patients delirious or demented / unable to give consent.
  • 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
  • BMI ≥35

Treatment and study plan

High Flow Nasal Cannula

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

nasoprong oxyen 2Litres per minute

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

Primary outcomes

  1. Incident of intraoperative desaturation

    Time frame: From induction time until end of surgery

    desaturation is taken as any spO2 <94%

  2. Patient comfort on high flow nasal cannula

    Time frame: At end of surgery till discharge to ward (recovery area)

    Patient rate comfort level using Visual Numerical Scale. The scale of 1 to 5 with 1 being extreme discomfort, 3 neutral and 5 extreme comfort

  3. Atelactasis

    Time frame: From end of operation until 24 hours post surgery

    Incident of postoperative atelectasis by compraring the preoperative and postoperative chest x ray by a radiologist

Secondary outcomes

  1. Length of hospital stay

    Time frame: Time of hospital admission to time of discharge up to 30 days which ever come first

    Duration of hospital admission from the time of patient admitted to the hospital, until discharge from hospital

Sponsors and collaborators

Lead sponsor

Universiti Kebangsaan Malaysia Medical Centre

Other

Registry information

Official study title

Comparing Intraoperative High Flow Nasal Cannula Therapy and Convetional Oxygen Therapy in Preventing Perioperative Hypoxaemia In Elderly Patients Undergoing Orthopaedic Surgery: A Randomized Controlled Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 26, 2023
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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