IRCT | Effectiveness of prone positioning combined with active cycle of breathing techniques in non intubated COVID-19 patients at Hayatabad Medical Complex, Peshawar.

Protocol summary

Study aim: Literature has reported beneficial effects of prone positioning but in our region the use of this positioning is dependent on patients’ will. Currently to the investigator’s knowledge, no such trial has been documented comparing prone positioning and prone positioning combined with ACBTs, studies only showed that prone positioning is feasible and effective for COVID-19 patients. so the aim of this study is to determine the effectiveness of prone positioning combined with ACBT techniques in non-intubated COVID-19 patients at HAYATABAD MEDICAL COMPLEX, PESHAWAR.
Design: Randomized controlled trial
Settings and conduct: The data will be collected from 97 patients admitted in Hayatabad Medical complex Peshawar. Participants and assessor will be blinded
Participants/Inclusion and exclusion criteria: Inclusion Criteria: i. Admitted patients ii. Laboratory confirmed SARS-COV-2 having PCR or pharyngeal swab positive. iii. Both male and female gender. iv. Age ≥18 years. v. Noninvasive ventilation Exclusion Criteria: i. Intubated patients ii. Pregnancy iii. Patient inability to tolerate prone positioning iv. Hemodynamically unstable (SBP<90mmhg) or arrhythmias v. Pressure sores vi. Seizures vii. Recent abdominal surgery1)
Intervention groups: This control group will comprise of prone positioning for 1 hour session, five sessions per day each spaced 2 hours for 1 week. The interventional group will be same as control group but with addition of ACBT technique. The technique comprises breathing Control in which patient will breathe in and out gently through nose then deep Breath through nose hold for 2-3 sec before breath out 3-5 times then huffing or Forced Expiratory Technique to remove secretions for 15-20 minutes for 1 week
Main outcome variables: 1. heart rate 2. respiratory rate 3 blood pressure 4 oxygen saturation

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20211103052957N1

Registration date: 2021-11-10, 1400/08/19

Registration timing: prospective

Last update: 2021-11-10, 1400/08/19

Update count: 0
Registration date: 2021-11-10, 1400/08/19

Registrant information: Name

Zainab Jahan

Name of organization / entity

Hayatabad Medical complex Peshawar Pakistan

Country

Pakistan

Phone

+92 91 9217140

Email address

zaib1012@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2021-11-18, 1400/08/27
Expected recruitment end date: 2022-01-18, 1400/10/28
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Effectiveness of prone positioning combined with active cycle of breathing techniques in non intubated COVID-19 patients at Hayatabad Medical Complex, Peshawar.

Public title: Effectiveness of prone positioning combined with active cycle of breathing techniques in non intubated COVID-19 patients at Hayatabad Medical Complex, Peshawar.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Admitted patients Laboratory confirmed SARS-COV-2 having PCR or pharyngeal swab positive Both male and female gender Age ≥18 years. Noninvasive ventilation

Exclusion criteria:

Intubated patients Pregnancy Patient inability to tolerate prone positioning Hemodynamically unstable (SBP<90mmhg) or arrhythmias Pressure sores Seizures Recent abdominal surgery
Age: From 18 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant
Outcome assessor

Sample size

Target sample size: 97

Randomization (investigator's opinion)

Randomized

Randomization description

After participants are selected, they will be randomly allocated to control group and experimental group using lottery method in which they will asked to select a piece of paper from a box. The piece of paper will be marked with initial of the groups (such as A or B) and then the participants will be allocated to the group initial that was on paper

Blinding (investigator's opinion)

Double blinded

Blinding description

Due to nature of study, it will not be feasible to blind researcher/therapist. However, assessor, who will assess pre and post measurements, will be blinded.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Hospital research and ethical committee (IRED)

Street address

Phase 4 Hayatabad Peshawar

City

Peshawar

Postal code

25000
Approval date: 2021-09-09, 1400/06/18
Ethics committee reference number: 526/HEC/B&PSC/2021

Health conditions studied

1

Description of health condition studied: COVID-19
ICD-10 code: U07.1
ICD-10 code description: U07. 1 COVID-19, virus identified

Primary outcomes

1

Description: Oxygen saturation
Timepoint: Outcomes will be measure after each treatment session for 7 consecutive days.
Method of measurement: The outcomes will be measured by using pulse oximeter and cardiac monitor

2

Description: Respiratory rate
Timepoint: Outcomes will be measure after each treatment session for 7 consecutive days.
Method of measurement: The outcomes will be measured by using pulse oximeter and cardiac monitor

3

Description: Heart rate
Timepoint: Outcomes will be measure after each treatment session for 7 consecutive days.
Method of measurement: The outcomes will be measured by using pulse oximeter and cardiac monitor

4

Description: Blood pressure
Timepoint: Outcomes will be measure after each treatment session for 7 consecutive days.
Method of measurement: The outcomes will be measured by using pulse oximeter and cardiac monitor

Secondary outcomes

empty

Intervention groups

1

Description: Control group: prone positioning for 1 hour after every 2 hours 5 times a day for 7 days
Category: Treatment - Other

2

Description: Intervention group: prone positioning with ACBT for 1 hour after every 2 hours 5 times a day for 7 days
Category: Treatment - Other

Recruitment centers

1

Recruitment center: Name of recruitment center

Hayatabad Medical complex

Full name of responsible person

Professor Dr . Wajid Ali Akhunzada

Street address

Phase 4 Hayatabad Peshawar

City

Peshawar

Postal code

25000

Phone

+92 91 9217140

Email

info@hmckp.gov.pk

Web page address

https://www.hmckp.gov.pk/

1

Sponsor: Name of organization / entity

Khyber Medical University, Peshawar, Pakistan.

Full name of responsible person

Dr. Mujeeb Ur Rehman

Street address

Phase 4 Hayatabad Peshawar

City

Peshawar

Postal code

25000

Phone

+92 91 9217703

Fax

+92 91 9217704

Email

info@kmu.edu.pk

Web page address

https://www.kmu.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Khyber Medical University, Peshawar, Pakistan.
Proportion provided by this source: 1
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Khyber Medical University

Full name of responsible person

Zainab Jahan

Position

Student

Latest degree

Medical doctor

Other areas of specialty/work

Physiotherapy

Street address

Phase 4 Hayatabad Peshawar

City

Peshawar

Province

Khyber pakhtun khwa

Postal code

25000

Phone

+92 91 5254545

Email

zaib1012@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Khyber Medical University

Full name of responsible person

Zainab Jahan

Position

student

Latest degree

Medical doctor

Other areas of specialty/work

Physiotherapy

Street address

Phase 4 Hayatabad Peshawar

City

Peshawar

Province

Khyber pakhtun khwa

Postal code

25000

Phone

+92 91 5254545

Fax

Email

Zaib1012@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Khyber Medical University

Full name of responsible person

Zainab Jahan

Position

Student

Latest degree

Medical doctor

Other areas of specialty/work

Physiotherapy

Street address

Phase 4 Hayatabad Peshawar

City

Peshawar

Province

Khyber pakhtun khwa

Postal code

25000

Phone

+92 91 5254545

Email

zaib1012@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Yes - There is a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: the data regarding outcome measures and demographics will be shared
When the data will become available and for how long: the data will be available after the completion of study.
To whom data/document is available: people in academic institutes and working in clinical setups will be able to access this data
Under which criteria data/document could be used: the data could be used for experimental analysis by clinicians or academicians.
From where data/document is obtainable: the data can be obtained from principal author through email address zaib1012@gmail.com
What processes are involved for a request to access data/document: the applicants will email to the author who will respond them asap.
Comments

Effectiveness of prone positioning combined with active cycle of breathing techniques in non intubated COVID-19 patients at Hayatabad Medical Complex, Peshawar.