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

NCT03024112 | Completed Results

• 1 other identifier: 12-1403
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-operative Pulmonary Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hospital Length of Stay

  30 days

• Lowest Oxygen Saturation Level Measured

  30 days

• ICU Length of Stay

  30 days

Study Arms (2)

Heated humidified high-flow nasal cannula (HHFNC) oxygen

EXPERIMENTAL

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

Standard oxygen Therapy

ACTIVE COMPARATOR

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

Interventions

Heated humified high-flow nasal cannula Oxygen DEVICE

Heated humidified high-flow nasal cannula (HHFNC) oxygen

Standard oxygen therapy OTHER

Standard oxygen Therapy

Eligibility Criteria

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

You may qualify if:

• Undergoing Thoracic surgery
• Planned admission to ICU after surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Unversity of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Results Point of Contact

• Title: Dr. Jason Brainard
• Organization: University of Colorado, Denver

Jason.Brainard@ucdenver.edu

720-848-3257

Study Officials

• Jason Brainard, M.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 18, 2017
• Study Start: August 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 5, 2017
• Results First Posted: December 5, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)