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Completed

NCT Number: NCT02117908

Study of the Application of CPAP to Reduce Complications and Improve Lung Cancer Ablation Radiofrequency Treatment

The project aims to study whether the application of a continuous positive airway pressure (CPAP) of 4 cm water vapor is a safe method in pulmonary radiofrequency intervention (PRF) lung cancer under conscious sedation compared with placebo. And, assess whether CPAP prevents atelectasis formation and consequently reduces the potential complications of PRF and improves procedural success

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Key information

Conditions

Atelectasis Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pulmonary Atelectasis 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

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male and female aged 18 years and older
  • Patient with a scheduled intervention for ablation of pulmonary malignant tumor with radiofrequency .
  • Patient able to undergo tests and examinations required by the study.

Exclusion criteria

  • Patients with CPAP intolerance test.
  • Patients with progressive disease in which local treatment is not applicable
  • Patients with intercurrent process (pleural effusion, pneumonia, ...).
  • Patient unable to understand the proceedings.
  • Pregnancy or breastfeeding.

Treatment and study plan

RESMED AUTOSET S9

Device

Continuous positive pressure during surgery

Primary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety

    Time frame: thirty days

    Patients with any of the following complications

    Pulmonary over-distention along intervention Pneumothorax along intervention Bronchial fistulas measures Computed tomography (CT)1, CT2 and CT3 Vomiting along intervention Decrease in MAP (mean arterial pressure) > 20% measured in the intraoperative period

    Assay of each of the previous complications

Secondary outcomes

  1. Prevention of atelectasis.

    Time frame: during surgery

    Atelectasic area Normal ventilation pulmonary area Hypoventilation pulmonary area Hyperventilation pulmonary area Bronchial wall injury distance

  2. Decrease associated complications with PFR. Measurement times: intraoperative, PACU (post-anesthesic care unit), hospital discharge, day 15 and day 30.

    Time frame: thirty days

    Major complications (death, failure to complete treatment, need for manual ventilation, intubation or resuscitation, pulmonary hemorrhage, need for pleural drainage, shock, fistulas, nerve injury, diaphragmatic injury, persistent pain, infections, increased hospitalization time and readmission rates) and any classified as a serious adverse event.

  3. Treatment success

    Time frame: Measurement time: CT3

    Tumor ablation range, measured in CT3.

  4. Predictors factors of the occurrence of complications during PRA (pulmonary radiofrequency ablation).

    Time frame: thirty days

    Minor complications (transient episodes of hypoxemia, apnea / hypoventilation or hypotension, pneumothorax without clinic symptoms or drainage, increased need for sedation, longer procedure) and any other event adverse not classified as serious.

Sponsors and collaborators

Lead sponsor

Sara Varea

Other

Collaborators

  • Ministerio de Economía y Competitividad, Spain

Registry information

Official study title

Application of CPAP to Reduce Complications and Improve Treatment of Radiofrequency Ablation of Lung Cancer Under Conscious Sedation. A Randomized Study

Acronym: CPAP-RFP

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 21, 2014
Registry last updated
Jul 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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