NCT04446520

Brief Summary

Purpose: This study will find out the effect of Autogenic drainage on the prevention of pulmonary complications after upper abdominal surgery. Method: Sixty patients post upper abdominal surgeries will be included, their ages ranged from 50 to 60 years old. The patients will be divided into two groups, study group (A) include patients that receive first traditional physiotherapy (localized breathing exercise, diaphragmatic breathing, and splinted coughing) then autogenic drainage (B)-Group B: patients that receive traditional physiotherapy (localized breathing exercise, diaphragmatic breathing and splinted coughing)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

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

First Submitted

Initial submission to the registry

June 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

June 27, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2020

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2020

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

June 21, 2020

Last Update Submit

November 23, 2020

Conditions

Postoperative Complications

Keywords

Autogenic drainageblood gasesPneumonia,upper abdominal surgeryPostoperative pulmonary Complications

Outcome Measures

Primary Outcomes (1)

  • arterial blood gases

    7 days

Secondary Outcomes (1)

  • prevalence of post operative pulmonary complication (pneumonia, hypoxemia and atelectasis) and number of days staying in ICU

    7 days

Study Arms (2)

autogenic drainage and traditional physiotherapy

EXPERIMENTAL

autogenic drainage technique plus traditional physiotherapy (localized breathing exercise, diaphragmatic breathing and splinted coughing)

Procedure: autogenic drainage

traditional physiotherapy

ACTIVE COMPARATOR

traditional physiotherapy (localized breathing exercise, diaphragmatic breathing, and splinted coughing)

Procedure: autogenic drainage

Interventions

autogenic drainagePROCEDURE

breathing control using expiratory airflow to mobilize secretions from smaller to larger airways. Secretions are cleared independently by adjusting the depth and speed of respiration in a sequence of controlled breathing techniques during exhalation in addition to traditional physiotherapy (deep breathing exercise, diaphragmatic breathing and splinted coughing)

autogenic drainage and traditional physiotherapytraditional physiotherapy

Eligibility Criteria

Age50 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age from 50 to 60 years
  • Patients undergoing elective upper abdominal surgery with an abdominal incision longer than 5 cm that is above or extending above the umbilicus.
  • Non-smoker patients

You may not qualify if:

  • Patients developing cancer
  • Patients with rib fractures
  • Inability to comprehend and follow instructions.
  • Pre-existing obstructive sleep apnea
  • Current hospital patient for a separate episode of care.
  • Patients requiring esophageal surgery or organ transplant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alaini

Cairo, 11711, Egypt

Location

Related Publications (1)

  • Taha MM, Draz RS, Gamal MM, Ibrahim ZM. Adding autogenic drainage to chest physiotherapy after upper abdominal surgery: effect on blood gases and pulmonary complications prevention. Randomized controlled trial. Sao Paulo Med J. 2021 Nov 15;139(6):556-563. doi: 10.1590/1516-3180.2021.0048.0904221. eCollection 2021.

    PMID: 34787294DERIVED

MeSH Terms

Conditions

Postoperative ComplicationsPneumonia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mona Taha, PhD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSISTANT PROFESSOR

Study Record Dates

First Submitted

June 21, 2020

First Posted

June 25, 2020

Study Start

June 27, 2020

Primary Completion

August 28, 2020

Study Completion

September 5, 2020

Last Updated

November 24, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)