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Completed

NCT Number: NCT02544477

High-flow Nasal Cannula Oxygen Versus Conventional Oxygen Therapy After Pulmonary Lobectomy

The primary objective of this study is to evaluate the effect of early application of nasal high flow oxygen therapy after pulmonary lobectomy on the incidence of postoperative hypoxemia

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Key information

Conditions

Respiratory Insufficiency Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiration Disorders Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Agostino Gemelli

Rome, 00168, Italy

About this study

High-flow nasal cannula oxygen (HFNCO) treatment has been showed to have several clinical advantages compared with conventional oxygen therapy. Currently, no reports have described the effects of HFNCO in postoperative patients after thoracic surgery. The primary objective of this study is to determine the incidence of postoperative hypoxemia (defined as a PaO2/FiO2 ratio <300) in patients with lung cancer after pulmonary lobectomy.

In the postoperative period after extubation, patients will be randomly assigned to either:

  • standard oxygen therapy group (control group) or
  • HFNCO group (study group).

In the control group, patients will receive oxygen treatment by means of a conventional face mask, with a level of fraction of inspired oxygen (FiO2) set to maintain peripheral oxygen saturation (SpO2) = 92% - 98%. Patients in the study group will be given HFNCO treatment with a gas flow level = 50 L/min and a FiO2 set to maintain peripheral oxygen saturation (SpO2) = 92% - 98%. After 48 hours from study entry, all patients will be evaluated for possible interruption of oxygen treatment on the basis of their clinical conditions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • planned pulmonary lobectomy for lung cancer

Exclusion criteria

  • age <18 years
  • patient refusal
  • body mass index ≥35 kg/m2
  • sleep apnea syndrome
  • tracheostomy
  • home oxygen therapy
  • pregnancy

Treatment and study plan

High-flow Nasal Cannula Oxygen (HFNCO)

Device

Conventional oxygen treatment

Device

Primary outcomes

  1. Number of patients with hypoxemia (defined as a PaO2/FiO2 ratio <300) after pulmonary lobectomy in patients with lung cancer

    Time frame: during the first 96 hours after surgery

Secondary outcomes

  1. Number of patients with SpO2 <93% in room air

    Time frame: after 48 hours from surgery and until 7th post operative day

  2. Number of patients undergoing endotracheal intubation or non-invasive ventilation for acute respiratory failure

    Time frame: during the first 7 days after surgery

    Respiratory failure will be defined as the presence of at least two of the following:

    • respiratory acidosis (arterial pH ≤7.35 with PaCO2 ≥ 45 mm Hg);
    • SpO2 < 90% or PaO2 < 60 mmHg at an FiO2 ≥ 0.5;
    • respiratory frequency > 35/min;
    • altered state of consciousness;
    • clinical signs of respiratory muscle fatigue.

    Respiratory failure will be treated using noninvasive ventilation (NIV), except when endotracheal intubation (ETI) will be required, i.e., when any of the following clinical events will be present:

    • respiratory or cardiac arrest;
    • respiratory pauses with loss of consciousness or gasping;
    • psychomotor agitation inadequately controlled by sedation;
    • massive aspiration;
    • persistent inability to remove respiratory secretions;
    • heart rate < 50/min with loss of alertness;
    • severe hemodynamic instability without response to fluids and vasoactive drugs. Patients with deterioration of blood gases or tachypnea despite 1 hour of NIV will undergo ETI.

  3. Postoperative pulmonary complications

    Time frame: during the first 7 days after surgery

  4. Respiratory discomfort evaluated by VAS (visual analogic scale) ranging from 0 (no discomfort) to 10 (maximum imaginable discomfort)

    Time frame: during the first 96 hours after surgery

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 9, 2015
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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