NCT02519517

Brief Summary

Investigators studied 15 patients scheduled for pulmonary resection through thoracotomy. Initial tidal volume (VT) 10ml kg-1 was reduced to 8ml kg-1 after one lung ventilation (OLV) and the rate adjusted to maintain partial pressure of arterial carbon dioxide (PaCO2) 30-35 mm Hg. Data were obtained at: T1, 15 min post establishing OLV with normocapnia, T2, 15 min post establishing OLV with hypercapnia (PaCO2 7.98kPa (60mmHg) and 9.31kPa (70mmHg) and pH \>7.1), and T3, 15 min after resuming OLV with normocapnia. One-way repeated measures analysis of variance (ANOVA), with post hoc Dunnet´s test were used for analysis. A P value \< 0.05 is considered statistically significant.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

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

November 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 11, 2015

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

1.4 years

First QC Date

June 20, 2015

Last Update Submit

August 6, 2015

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Right ventricular systolic and diastolic functions measured by Tei index

    Tei index and Tricuspid Annular Plane Systolic Excursion (TAPSE) were used to assess both RV systolic and diastolic functions

    Intraoperative

Study Arms (1)

permissive hypercapnia

EXPERIMENTAL

during one lung ventilation, right ventricular function was assessed by TEE and the effect of rising PCO2 appreciated

Procedure: Permissive hypercapnia

Interventions

Permissive hypercapniaPROCEDURE

During one lung ventilation, right ventricular function was assessed by transesophageal echocardiography (TEE) and the effect of increased carbon dioxide pressure was evaluated

permissive hypercapnia

Eligibility Criteria

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

You may qualify if:

  • adult \>18 yr
  • elective pulmonary resection through thoracotomy.

You may not qualify if:

  • Patients with pulmonary hypertension (systolic \>50mmHg),
  • intracranial hypertension or previous intracranial haemorrhage,
  • pre-existing hypercapnia,
  • co-existing metabolic acidosis,
  • ischaemic heart disease,
  • predicted postoperative FEV1\<800 ml or \<40% of the expected in pneumonectomy
  • patient in which transesophageal echocardiography was contraindicated or necessary measurements were difficult to assess.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant (associate) professor

Study Record Dates

First Submitted

June 20, 2015

First Posted

August 11, 2015

Study Start

November 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

August 11, 2015

Record last verified: 2015-08