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

NCT06054022 | Completed DMC

• 1 other identifier: FFP-2020-245
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypoxemia During Surgery; Atelectasis

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Incident of intraoperative desaturation

  desaturation is taken as any spO2 \<94%

  From induction time until end of surgery

• Patient comfort on high flow nasal cannula

  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

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

• Atelactasis

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

  From end of operation until 24 hours post surgery

Secondary Outcomes (1)

• Length of hospital stay

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

Study Arms (2)

patient receiving high flow nasal cannula (A)

EXPERIMENTAL

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%.

Device: high flow nasal cannula

patient receiving nasoprong oxygen 2 L/min

ACTIVE COMPARATOR

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%.

Device: nasoprong oxyen 2Litres per minute

Interventions

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

patient receiving high flow nasal cannula (A)

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

patient receiving nasoprong oxygen 2 L/min

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Universiti Kebansaan Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Pulmonary Atelectasis; Hypoxia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Syarifah noor nazihah binti sayed masri, MD

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: there will be no masking except for the radiologist who compares the postoperative chest x-ray with the baseline
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: September 26, 2023
• Study Start: July 7, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2021
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)