Non-invasive Ventilation Assisted Fiber-optic Bronchoscopy

ConditionsLungDiseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMansoura University

About this trial

The purpose of this study is the evaluation of using bi-level positive airway pressure ventilation in candidates for fiber-optic bronchoscopy regarding benefits and drawbacks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who admitted to the pulmonology ward or intensive care unit with any (diagnostic and/or therapeutic) bronchoscopy indication.

Age 18 years or more.

Patients accepted to participate in the study.

Disqualifiers

Cardiac or respiratory arrest.

Impaired consciousness or confusion.

Type II respiratory failure.

Hemodynamic instability.

Trial design

Design model

Parallel

Treatments tested in this trial

  • non- invasive ventilator

    Device

    Group 1 (hypoexemic patient who will undergo bronchoscopy under non- invasive ventilation{NIV} and conventional o2 therapy) will be on NIV half an hour prior and throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria

  • fiber-optic bronchoscopy

    Device

    Group 2 (hypoxemic patients who will undergo conventional bronchoscopy under conventional o2 therapy without NIV ) will be on conventional oxygen therapy half an hour prior and throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria

  • non- invasive ventilator

    Device

    Group 3 (non- hypoxemic patients who will undergo bronchoscopy under non- invasive ventilation{NIV} and conventional o2 therapy) will be on NIV throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria

  • fiber-optic bronchoscopy

    Device

    Group 4 (non- hypoxemic patients who will undergo conventional bronchoscopy without non- invasive ventilation{NIV) will be on conventional oxygen therapy throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: (Group 1) 25 (H. NIV): Hypoxemic patients{hypoxemic NIV group}Active comparator 2 interventions
Group B: (Group 2) 25 (H. conv.): Hypoxemic patients{hypoxemic conventional group }Active comparator 1 intervention
Group C: (Group 3) 25 (N.H.NIV): Non- hypoxemic patients{non-hypoxemic NIV group}Active comparator 2 interventions
Group D: (Group 4) 25(N.H. conv.): Non- hypoxemic patients{non-hypoxemic conventional group}Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Evaluation of the changes in oxygen saturation, heart rate, respiratory rate, blood pressure, dyspnea score and arterial blood gases in bronchoscopy procedure

Evaluate changes and when to reach base line in each of 1- (SPO2) by pulse oximeter in (percentage %) at base line, 15 minute before, during and immediately after bronchoscopy. 2-heart rate in (beat/minute) at base line, 15 minute before, during and immediately after bronchoscopy. 3-respiratory rate in (cycle/minute) at base line, 15 minute before, during and immediately after bronchoscopy. 4-mean arterial blood pressure in {millimeter/mercury mm/Hg)} at base line, 15 minute before, during and immediately after bronchoscopy. 5-dyspnea score in {grade 0-3 according to: (mMRC)} 15 minute before and immediately after bronchoscopy. arterial blood gases (PH, Paco2 in {millimeter/mercury (mm/Hg)}, Pao2 in {millimeter/mercury (mm/Hg)},Spo2 (percentage %) andHco3 in {millimol (mmol/l)} before and after bronchoscopy. To show effects of using NIV and conventional o2 therapy and using of conventional o2 therapy alone on these parameters in the studied patients in bronchoscopy.

Time frame
4 years

Secondary outcomes

1

Fiber-optic bronchoscopy complications

The need for intubation, if it occurs within two to eight hours of bronchoscopy, it was considered as a complication possibly related to bronchoscopy. This time span was adopted from previous studies (Hilbertet et al., 2001). Also the existence of complications as hemorrhage, pneumothorax, hypotension, arrhythmia) that occurred during bronchoscopy and in the first 24 hours following bronchoscopy, which could possibly be related to the procedure (Schönhofer et al., 2008).

Time frame
4 years

Other outcomes

Sponsors and contacts

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