NCT02039466

Brief Summary

Postoperative pulmonary complications following abdominal surgery are frequent and associated with increased morbidity and mortality and hospital length of stay. Pressure controlled ventilation will improve oxygenation indices , hemodynamics during anesthesia for laparoscopic colectomy, decreasing postoperative pulmonary complications.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 17, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 11, 2014

Status Verified

July 1, 2014

Enrollment Period

11 months

First QC Date

January 16, 2014

Last Update Submit

July 10, 2014

Conditions

Postoperative Respiratory Complication

Outcome Measures

Primary Outcomes (1)

  • peak airway pressure in patients receiving pressure controlled ventilation and volume controlled ventilation

    40 minutes after pneumoperitoneum

Study Arms (2)

volume controlled ventilation

ACTIVE COMPARATOR

volume controlled ventilation as a tidal volume of 8 ml/kg (ideal body weight)

Procedure: volume controlled ventilation

pressure controlled ventilation

ACTIVE COMPARATOR

pressure controlled ventilation as a tidal volume of 8 ml/kg (ideal body weight)

Procedure: pressure controlled ventilation

Interventions

volume controlled ventilationPROCEDURE
volume controlled ventilation
pressure controlled ventilationPROCEDURE
pressure controlled ventilation

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status classification
  • patients scheduled for laparoscopic colectomy

You may not qualify if:

  • severe cardiopulmonary disease
  • patients who cannot understand Korean

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung-Ang University Hospital

Seoul, Seoul, 156-755, South Korea

RECRUITING

Central Study Contacts

Soyoung Yang, clinical assistant professor

CONTACT

82-2-6299-3160didth79@hanmail.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
So Young Yang. MD.PHD

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 17, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

July 11, 2014

Record last verified: 2014-07

Locations

KR(1)