NCT02297828

Brief Summary

The purpose of this study is to determine if the application of Boussignac continuous positive airway pressure (CPAP) immediately after extubation improves PaO2 and PaO2/FiO2 ratio in morbidly obese patients undergoing gastric bypass surgery .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

1 month

First QC Date

November 17, 2014

Last Update Submit

April 23, 2015

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (2)

  • Difference in mean PaO2 values after surgery

    Arterial blood samples for blood gas analysis are collected at 1 hour, 2 hours and 24 hours post-extubation. The differences in the mean values of PaO2 are registered and analysed.

    24 hours

  • Difference in mean PaO2/FiO2 ratio values after surgery

    Arterial blood samples for blood gas analysis are collected at 1 hour, 2 hours and 24 hours post-extubation. The differences in the mean values of PaO2/FiO2 ratio are registered and analysed.

    24 hours

Secondary Outcomes (1)

  • Difference in mean FEV 1 and FVC values

    24 hours

Study Arms (2)

Boussignac CPAP

EXPERIMENTAL

Boussignac CPAP with a 50% FiO2 (adjusted in a piece adapted to the system) and a pressure of 5cmH2O (measured with a manometer) is applied immediately after extubation and mantained for two hours after extubation in the post anesthesia care unit (PACU). Arterial blood samples to measure PaO2 and PaO2/FiO2 ratio are collected before surgery and at 1, 2 and 24 hours after extubation. Spirometry is performed at the same intervals measuring FEV1 and FVC.

Device: Boussignac CPAP

Ventury face mask

ACTIVE COMPARATOR

Venturi mask with a 50% FiO2 is used immediately after extubation and mantained for two hours in the post anesthesia care unit (PACU). Arterial blood samples to measure PaO2 and PaO2/FiO2 ratio are collected before surgery and at 1, 2 and 24 hours after extubation. Spirometry is performed at the same intervals measuring FEV1 and FVC.

Device: Venturi face mask

Interventions

Boussignac CPAPDEVICE

Boussignac CPAP with a 50% FiO2 (adjusted in a piece adapted to the system) and a pressure of 5cmH2O (measured with a manometer) is applied immediately after extubation and mantained for two hours after extubation in the post anesthesia care unit (PACU).

Boussignac CPAP
Venturi face maskDEVICE

Venturi mask with a 50% FiO2 is used immediately after extubation and mantained for two hours in the post anesthesia care unit (PACU).

Ventury face mask

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients age between 18 and 65 years of age
  • Morbidly obese with a body mass index \> 35 kg/m2
  • Laparoscopic gastric bypass

You may not qualify if:

  • Patient refusal
  • American Society of Anesthesiologists' (ASA) class IV
  • Lung parenchyma disease
  • Chronic Obstructive Pulmonary Disease
  • Moderate to severe asthma
  • Pre-existing cardiac failure (above class II in the New York Heart Association (NYHA) classification)
  • Estimated pulmonary artery pressure ≥35mmHg
  • Hemoglobin concentration (\[Hgb\]) less than 7 g / dL
  • Need for invasive ventilation during preoperative immediate post-extubation defined in the preoperative period
  • Patients with obstructive sleep apnea previously treated with CPAP
  • Severe psychiatric disorder
  • Language barrier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Hospitalar Porto

Porto, 4099-001, Portugal

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joana Guimarães, MD

    Centro Hospitalar do Porto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 17, 2014

First Posted

November 21, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

April 24, 2015

Record last verified: 2015-04

Locations

PT(1)