NCT05548309

Brief Summary

Eighty adult patients were randomly categorized into two equal groups (forty patients each): HFNC was applied to group I, and a simple oxygen face mask was applied to group II. Postoperative pulmonary complications were assessed for five days later.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

12 months

First QC Date

September 12, 2022

Last Update Submit

September 16, 2022

Conditions

Post Operative Pulmonary Complications

Keywords

HFNCPulmonary complications

Outcome Measures

Primary Outcomes (1)

  • To compare the effect of HFNC and simple face mask oxygen therapy regarding postoperative pulmonary complications within five days after major elective upper abdominal surgeries.

    postoperative pulmonery complications detected by lung ultrasound and chest x-ray

    5 days postoperatively

Secondary Outcomes (3)

  • To detect the need for escalation of respiratory support

    5 days postoperatively

  • Intensive care unit length of stay(days)

    14 days postoperatively

  • Hospital length of stay(days)

    21 days postoperatively

Study Arms (2)

High flow nasal cannula

ACTIVE COMPARATOR

High flow nasal cannula (HFNC) was inserted through nasal prongs (Fisher \& Paykel Healthcare, Auckland, New Zealand) . FiO2 was continuously measured by a dedicated system (AIRVO™ 2; Fisher \& Paykel Healthcare, Auckland, New Zealand) .

Device: HFNC

oxygen face mask

ACTIVE COMPARATOR

Simple oxygen face mask was applied to patients starting with flow rate 6L/min .

Device: Oxygen face mask

Interventions

HFNCDEVICE

High flow nasal cannula (HFNC) was inserted through specific medium/large nasal prongs . FiO2 was continuously measured by a dedicated system (AIRVO™ 2; Fisher \& Paykel Healthcare, Auckland, New Zealand) connected to the HFNC. Starting flow 35 L/min, temperature 31oc. The flow was titrated up to 60L/min with a target SpO2 of ≥94%.

High flow nasal cannula
Oxygen face maskDEVICE

Oxygen face mask was applied to patients postoperatively with starting flow 8L/min and titration of flow up to 10 L/min with target SpO2 of ≥94%

oxygen face mask

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (50-70 years).
  • Patients with American Society of Anesthesiologists (ASA) status I-III.
  • Patients with body mass index less than 35kg/m2.
  • Patients scheduled for major elective upper abdominal surgeries (gastrectomy, hepatic resection, pancreatectomy, Whipple procedures,..).
  • Upper abdominal surgery with an abdominal incision longer than 5 cm that is above or extending above the umbilicus.
  • Upper abdominal surgeries with an anticipated duration of two hours or more.

You may not qualify if:

  • Patients with tracheostomy
  • Patients with pre-existing pulmonary disease (pleural effusion, pneumothorax or pulmonary atelectasis).
  • Patients with pre-existing obstructive sleep apnea.
  • Patients with any nasal or facial defect that could impede use of HFNC (Nasal septal defect or any form of facial deformity).
  • Impaired consciousness Glasgow coma scale (GCS) less than 12.
  • Hemodynamic instability as systolic blood pressure less than 90 mmHg, mean arterial blood pressure less than 65 mmHg or vasopressor requirement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University,Faculty of Medicine

Alexandria, Egypt

Location

Study Officials

  • Dorya fekry, MD

    Alexandria University

    STUDY DIRECTOR

  • Ahmed EL-Attar, MD

    Alexandria University

    STUDY DIRECTOR

  • Mohamed El Hadidy, MD

    Alexandria University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer,alexandria university

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 21, 2022

Study Start

April 30, 2021

Primary Completion

April 29, 2022

Study Completion

July 15, 2022

Last Updated

September 21, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

clinical trial

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
one month

Locations

EG(1)