NCT04389047

Brief Summary

Comparison the effect of two different mechanical ventilation modes on tissue oxygenization.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2013

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

1.2 years

First QC Date

January 20, 2020

Last Update Submit

May 11, 2020

Conditions

Keywords

bariatric surgery, tissue oxygenization, ventilation

Outcome Measures

Primary Outcomes (6)

  • Oxygenization

    Peroperative Non invazive technique of Superficial Tissue Oxygenization

    peroperative 0. minute - 15. minute - 30. minute - 45. minute - 60. minute

  • Oxygenization-2

    Post operative Non invazive technique of Superficial Tissue Oxygenization

    post operative 1. hour - 4. hour - 8. hour - 12. hour - 24.hour

  • Arterial blood gas analysis

    Lactate, Ph, Arterial oxygen pressure, Arterial Carbondioxide pressure, Oxygen Saturation

    Peroperative 0. minute - 30. minute - 60. minute

  • Arterial blood gas analysis-2

    Lactate, Ph, Arterial oxygen pressure, Arterial Carbondioxide pressure, Oxygen Saturation

    post operative 1.hour - 4. hour - 8. hour - 12. hour - 24.hour

  • Peripheral oxygen saturation

    Peripheral Oxygen Saturation (SpO2)

    peroperative 0. minute - 15. minute - 30. minute - 45. minute - 60. minute

  • Peripheral oxygen saturation-2

    Peripheral Oxygen Saturation (SpO2)

    post operative 1.hour - 4. hour - 8. hour - 12. hour - 24.hour

Secondary Outcomes (3)

  • Peroperative hemodynamic measurements

    peroperative 0. minute - 15. minute - 30. minute - 45. minute - 60. minute

  • Postoperative hemodynamic measurements

    post operative 1.hour - 4. hour - 8. hour - 12. hour - 24.hour

  • Carbondioxide

    peroperative 15. minute - 30. minute - 45. minute - 60. minute

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Study population involves the elective bariatric surgery patients who have body mass index between 35 and 50 kg/m2.

You may qualify if:

  • Patients with Body Mass Index 35 - 50 kg/m2 Patients classified as American Society of Anesthesiologist (ASA) 1-2-3 classification Patients elected for Bariatric surgery

You may not qualify if:

  • Patients who wants to reject of study participation Patients who has any surgical complication during the surgery period Patients with decompensated cardiac failure Patients with Moderate or Severe obstructive/restrictive lung disease Patients with Reynaud disease Patients with Buerger phenomena Patients whıo has Intraoperative airway pressure more than 45 cmH2O Patients who had previous thoracic surgery Patients with Negative Modified Allen test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypoxiaRespiratory Aspiration

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesPathologic Processes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2020

First Posted

May 15, 2020

Study Start

January 10, 2012

Primary Completion

March 30, 2013

Study Completion

March 30, 2018

Last Updated

May 15, 2020

Record last verified: 2020-05