Impact of Prophylactic High Flow Nasal Oxygen in Post-Operative Thoracic Surgical Patients

The Investigators goal was to study the effect of high flow nasal cannula oxygen (HFNC) on the rate of post-operative pulmonary complications in thoracic surgical patients. The Investigators hypothesis is that prophylactic HFNC oxygen, as compared to standard oxygen treatment, will reduce the incidence of postoperative pulmonary complications, improve post-operative pulmonary function, and reduce Intensive Care Unit (ICU) and hospital length of stay.

Study Overview

• Status: Completed
• Conditions: Post-operative Pulmonary Complications
• Intervention / Treatment: Device: Heated humified high-flow nasal cannula Oxygen; Other: Standard oxygen therapy

Detailed Description

The Investigators goal was to study the effect of high flow nasal cannula oxygen (HFNC) on the rate of post-operative pulmonary complications in thoracic surgical patients. The Investigators hypothesis is that prophylactic HFNC oxygen, as compared to standard oxygen treatment, will reduce the incidence of postoperative pulmonary complications, improve post-operative pulmonary function, and reduce ICU and hospital length of stay.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Unversity of Colorado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Undergoing Thoracic surgery
• Planned admission to ICU after surgery

Exclusion Criteria:

• Younger than 18
• Pregnant
• Breast feeding
• Known diagnosis of obstructive sleep apnea
• Current or previous lung transplant
• Pneumonectomy
• Home oxygen greater than 4L/minute
• Inability to adhere to assigned treatment prior to 48 hours of surgery or until transferred to a floor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heated humidified high-flow nasal cannula (HHFNC) oxygen; The intervention group received HHFNC O2 at a set flow of 40L/min. FiO2 was titrated by respiratory therapists to maintain SpO2 ≥ 90%. The HHFNC O2 apparatus included: 1) Air-Oxygen blender - capable of delivering 21-100% FiO2 at flow rates up to 60L/min, 2) Heated Humidifier - providing active heating and humidification to the delivered air-O2 blend, 3) Nasal cannula - larger diameter, slightly elongated nasal cannula with single limb connection to humidifier	Device: Heated humified high-flow nasal cannula Oxygen
Active Comparator: Standard oxygen Therapy; The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%.	Other: Standard oxygen therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Post-operative Pulmonary Complications	The primary outcome "post-operative pulmonary complication" is defined as present if any one of the following criteria are met: SpO2 < 90% with FiO2 ≥ 50%; Dyspnea at rest; Respiratory rate > 25 breaths/min; Active use of accessory respiratory muscles; PaO2/FiO2 ratio < 200; Escalation of therapy to non-invasive ventilation; Re-intubation; Occurrence of hospital-acquired pneumonia; Re-admission to the ICU	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay	length of stay from hospital admission to hospital discharge	30 days
Lowest Oxygen Saturation Level Measured	Lowest oxygen saturation level measured during hospitalization from admission to discharge	30 days
ICU Length of Stay		30 days

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Jason Brainard, M.D., University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 13, 2017
• First Posted (Estimate): January 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2017
• Last Update Submitted That Met QC Criteria: December 4, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 12-1403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to share IPD