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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06054022
Enrollment
50
Registered
2023-09-26
Start date
2020-07-07
Completion date
2021-12-31
Last updated
2023-09-26

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

Conditions

Atelectasis, Hypoxemia During Surgery

Keywords

high flow nasal cannula, elderly, orthopaedic, hypoxaemia, regional anaesthesia

Brief summary

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

Detailed description

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

Interventions

DEVICEhigh 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

DEVICEnasoprong 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

Sponsors

Universiti Kebangsaan Malaysia Medical Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incident of intraoperative desaturationFrom induction time until end of surgerydesaturation is taken as any spO2 \<94%
Patient comfort on high flow nasal cannulaAt 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
AtelactasisFrom end of operation until 24 hours post surgeryIncident of postoperative atelectasis by compraring the preoperative and postoperative chest x ray by a radiologist

Secondary

MeasureTime frameDescription
Length of hospital stayTime of hospital admission to time of discharge up to 30 days which ever come firstDuration of hospital admission from the time of patient admitted to the hospital, until discharge from hospital

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026