Trial Outcomes & Findings for Impact of Prophylactic High Flow Nasal Oxygen in Post-Operative Thoracic Surgical Patients (NCT NCT03024112)

NCT ID: NCT03024112

Last Updated: 2017-12-05

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 51 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2017-12-05

Participant Flow

Participant milestones

Measure	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 Heated humified high-flow nasal cannula Oxygen	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%. Standard oxygen therapy
Overall Study STARTED	25	26
Overall Study COMPLETED	18	26
Overall Study NOT COMPLETED	7	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen n=18 Participants 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 Heated humified high-flow nasal cannula Oxygen	Standard Oxygen Therapy n=26 Participants The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%. Standard oxygen therapy	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Age, Continuous	57 years n=5 Participants	59 years n=7 Participants	58 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	14 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	26 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

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

Outcome measures

Measure	Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen n=18 Participants 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 Heated humified high-flow nasal cannula Oxygen	Standard Oxygen Therapy n=26 Participants The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%. Standard oxygen therapy
Number of Participants With Post-operative Pulmonary Complications	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days

length of stay from hospital admission to hospital discharge

Outcome measures

Measure	Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen n=18 Participants 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 Heated humified high-flow nasal cannula Oxygen	Standard Oxygen Therapy n=26 Participants The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%. Standard oxygen therapy
Hospital Length of Stay	6.6 Days Standard Deviation 2.1	9.5 Days Standard Deviation 7

SECONDARY outcome

Timeframe: 30 days

Lowest oxygen saturation level measured during hospitalization from admission to discharge

Outcome measures

Measure	Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen n=18 Participants 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 Heated humified high-flow nasal cannula Oxygen	Standard Oxygen Therapy n=26 Participants The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%. Standard oxygen therapy
Lowest Oxygen Saturation Level Measured	88 percentage of oxygen saturation Standard Deviation 7	84 percentage of oxygen saturation Standard Deviation 7

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen n=18 Participants 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 Heated humified high-flow nasal cannula Oxygen	Standard Oxygen Therapy n=26 Participants The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%. Standard oxygen therapy
ICU Length of Stay	2 Days Standard Deviation 1.2	3.2 Days Standard Deviation 3.8

Adverse Events

Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Standard Oxygen Therapy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Heated Humidified High-flow Nasal Cannula (HHFNC) Oxygen n=18 participants at risk 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 Heated humified high-flow nasal cannula Oxygen	Standard Oxygen Therapy n=26 participants at risk The standard O2 treatment group received usual nasal cannula or face mask oxygen titrated by nurses as necessary to maintain SpO2 ≥ 90%. Standard oxygen therapy
Respiratory, thoracic and mediastinal disorders Pulmonary Complications	11.1% 2/18 • Number of events 2	7.7% 2/26 • Number of events 2

Additional Information

Dr. Jason Brainard

University of Colorado, Denver

Phone: 720-848-3257

Email: Jason.Brainard@ucdenver.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place